English Subtitles for Audio ID: 90809



Subtitles / Closed Captions - English

the conference is now being<font color="#E5E5E5"> recorded</font>

<font color="#CCCCCC">Gary Fox</font><font color="#E5E5E5"> have joined the conference slow</font> <font color="#E5E5E5">cuz like hello so</font><font color="#CCCCCC"> I was on mute then and</font> playing hi Gary good to talk<font color="#CCCCCC"> to</font><font color="#E5E5E5"> you yes how are you</font> sorry<font color="#E5E5E5"> I was getting on I have difficulty</font> getting<font color="#CCCCCC"> through the access process oh</font>

<font color="#CCCCCC">really I was</font><font color="#E5E5E5"> just and</font><font color="#CCCCCC"> typing you an</font> <font color="#CCCCCC">email on my phone to say are we having a</font> technological problem<font color="#CCCCCC"> or</font><font color="#E5E5E5"> something</font> cropped<font color="#E5E5E5"> up on your side and</font><font color="#CCCCCC"> was it just</font> saying the hosts<font color="#E5E5E5"> and the participant pin</font> wasn't recognized so what was the

problem<font color="#E5E5E5"> yes but I know it's</font><font color="#CCCCCC"> just</font><font color="#E5E5E5"> for</font> <font color="#CCCCCC">some</font><font color="#E5E5E5"> reason it didn't accept the</font><font color="#CCCCCC"> first</font> it didn't accept the ID number and then disconnected me so but finally I got through so that's good and if<font color="#CCCCCC"> it seems a bit late starting and</font>

there it's actually<font color="#E5E5E5"> in the middle of</font> your<font color="#E5E5E5"> day</font><font color="#CCCCCC"> it's my evening so I don't have</font> <font color="#E5E5E5">so many poor for my time are you still</font> <font color="#CCCCCC">okay for half an hour</font><font color="#E5E5E5"> or do you have a</font> hard stop<font color="#CCCCCC"> at</font><font color="#E5E5E5"> any point</font> yes<font color="#E5E5E5"> no no I'm I'm</font><font color="#CCCCCC"> all Topher for half an</font>

hour <font color="#E5E5E5">hopefully in which case let's dive</font> straight<font color="#E5E5E5"> in and thanks again</font><font color="#CCCCCC"> for</font> agreeing to listen to you<font color="#E5E5E5"> you're the</font> first<font color="#CCCCCC"> one to get</font><font color="#E5E5E5"> back to me so this is</font> <font color="#E5E5E5">the the</font><font color="#CCCCCC"> first interview I'm actually</font>

<font color="#E5E5E5">performing in terms of product profile I</font> sent one through yesterday<font color="#CCCCCC"> did you</font><font color="#E5E5E5"> have</font> a chance<font color="#CCCCCC"> just have a look at that just</font> <font color="#CCCCCC">to understand the</font><font color="#E5E5E5"> product we're</font><font color="#CCCCCC"> going</font> <font color="#E5E5E5">together yes I did I</font><font color="#CCCCCC"> look</font><font color="#E5E5E5"> through it and</font> we that didn't have any major questions

the there were a couple of minor comments that I<font color="#CCCCCC"> our questions that I had</font> but nothing major let me<font color="#E5E5E5"> just I'm at a</font> different<font color="#E5E5E5"> computer right now so let</font><font color="#CCCCCC"> me</font> just pull it<font color="#E5E5E5"> up on this computer</font><font color="#CCCCCC"> so</font><font color="#E5E5E5"> the</font> <font color="#E5E5E5">first part of the cool because</font><font color="#CCCCCC"> what we'd</font>

like to<font color="#E5E5E5"> do is and get your take on the</font> product profile but also understand in<font color="#CCCCCC"> general the the</font> patient<font color="#E5E5E5"> flow</font><font color="#CCCCCC"> and the overall market and</font> reimbursement environment before<font color="#CCCCCC"> and the</font> treatment of more severe dry eye disease

<font color="#E5E5E5">so if it's that</font><font color="#CCCCCC"> if you actually just</font> start on that<font color="#E5E5E5"> if that's</font><font color="#CCCCCC"> alright with you</font> <font color="#CCCCCC">and then get on to how you would</font><font color="#E5E5E5"> see</font> this fitting in and you know assuming <font color="#E5E5E5">the clinical data when it comes out in</font> July<font color="#CCCCCC"> is as we hope so</font><font color="#E5E5E5"> first of all if</font>

<font color="#E5E5E5">it's okay with you I'd</font><font color="#CCCCCC"> just like to</font> start with learning<font color="#CCCCCC"> a bit more about</font> where you<font color="#CCCCCC"> practice and the types of</font> patient you see and<font color="#E5E5E5"> it's the patient</font> journey<font color="#CCCCCC"> - that</font><font color="#E5E5E5"> they've taken in order to</font> come and see you whether or<font color="#E5E5E5"> not it sort</font>

of self referral or to pop<font color="#E5E5E5"> them</font><font color="#CCCCCC"> all up</font> optometrist or<font color="#E5E5E5"> you know how they</font> actually<font color="#E5E5E5"> come to see</font><font color="#CCCCCC"> especially such as</font> yourself<font color="#E5E5E5"> and said</font><font color="#CCCCCC"> know</font><font color="#E5E5E5"> that oh</font><font color="#CCCCCC"> yeah</font><font color="#E5E5E5"> yes</font> there<font color="#E5E5E5"> you go go ahead</font><font color="#CCCCCC"> oh shit yeah I</font> should preface it by saying<font color="#E5E5E5"> you</font><font color="#CCCCCC"> know I'm</font>

no longer in active clinical<font color="#E5E5E5"> practice</font><font color="#CCCCCC"> so</font> what I'm commenting<font color="#CCCCCC"> on is the practice</font> <font color="#CCCCCC">that I had most recently</font><font color="#E5E5E5"> was at</font> University of Louisville in Louisville Kentucky<font color="#CCCCCC"> is</font><font color="#E5E5E5"> the director of the cornea</font> service so this is based most recently

upon that but<font color="#CCCCCC"> I can also you know call</font> upon my experience<font color="#E5E5E5"> both at Duke</font> University<font color="#CCCCCC"> and</font><font color="#E5E5E5"> at the University of</font> Pittsburgh so where<font color="#CCCCCC"> are actors</font><font color="#E5E5E5"> before</font><font color="#CCCCCC"> oh no that</font> scrapes what we want to understand

really<font color="#CCCCCC"> is the</font><font color="#E5E5E5"> US market obviously it's</font> <font color="#CCCCCC">very different to the UK market</font><font color="#E5E5E5"> so in</font> terms of the US market<font color="#CCCCCC"> and and then the</font> practices<font color="#CCCCCC"> that you've been involved in</font> <font color="#E5E5E5">can you just talk me through in your own</font> words to type of patients that<font color="#E5E5E5"> you would</font>

<font color="#E5E5E5">get to see and how you got to see them</font> what proportion<font color="#E5E5E5"> would have dry eyes as</font> <font color="#E5E5E5">their as the problem for coming to see</font> you right<font color="#CCCCCC"> now well i was again sub</font> specialized training<font color="#CCCCCC"> in cornea</font><font color="#E5E5E5"> and</font> external disease and had done a lot<font color="#CCCCCC"> of</font>

war research work in dry eye disease<font color="#E5E5E5"> so</font> <font color="#E5E5E5">i was a tertiary referral for a lot of</font> <font color="#E5E5E5">the practices in both the</font> the city of<font color="#E5E5E5"> Louisville and previously in</font> Pittsburgh and in North Carolina<font color="#CCCCCC"> so I</font> would<font color="#E5E5E5"> tend to see the more complicated</font>

dry<font color="#E5E5E5"> eye patients</font> you referred either<font color="#E5E5E5"> by optometrists or</font> ophthalmologists<font color="#CCCCCC"> so a lot of the</font> patients<font color="#E5E5E5"> I saw were also</font><font color="#CCCCCC"> Sjogren's</font> syndrome<font color="#E5E5E5"> dry eye patients but the bulk</font> of<font color="#CCCCCC"> what was referred to me</font><font color="#E5E5E5"> was generally</font>

<font color="#CCCCCC">the dry eye patient that was symptomatic</font> despite<font color="#E5E5E5"> treatment with artificial tears</font> yes that was case<font color="#E5E5E5"> be</font><font color="#CCCCCC"> my</font><font color="#E5E5E5"> next question</font> <font color="#CCCCCC">here so has to</font><font color="#E5E5E5"> be the</font><font color="#CCCCCC"> driver religion</font> like I<font color="#CCCCCC"> said</font><font color="#E5E5E5"> well no III did maintain a</font> general general<font color="#E5E5E5"> practice as well but the</font>

percentage of dry eye patients specifically<font color="#E5E5E5"> in that general population</font> was not<font color="#E5E5E5"> as severe as what ended up being</font> referred<font color="#CCCCCC"> to me as a tertiary drawing eye</font> care specialists<font color="#E5E5E5"> so you know you have to</font> have<font color="#E5E5E5"> to remember that my perspective</font>

although<font color="#CCCCCC"> I did</font><font color="#E5E5E5"> maintain a general</font> practice<font color="#E5E5E5"> it was predominantly as a</font> tertiary referral specialist for dry eye now that's good because we're<font color="#E5E5E5"> actually</font> looking<font color="#CCCCCC"> to target</font><font color="#E5E5E5"> the more severe end of</font> dry eye and<font color="#CCCCCC"> in terms of getting referred</font>

to you<font color="#E5E5E5"> what are the criteria is it just</font> <font color="#E5E5E5">patient reported criteria or rather</font> specific measurements that optometrists <font color="#CCCCCC">or the people before you take</font><font color="#E5E5E5"> before</font> they get referred<font color="#E5E5E5"> to</font><font color="#CCCCCC"> you well if the</font> they pretty<font color="#E5E5E5"> much all had both symptoms</font>

<font color="#E5E5E5">and signs of dry eye occasionally there</font> would be patients who were sent with symptoms<font color="#CCCCCC"> only but those were were</font> <font color="#E5E5E5">oftentimes not your standard dry eye</font> population<font color="#E5E5E5"> they often times had</font> neuropathic<font color="#E5E5E5"> issues that</font>

that complicated<font color="#E5E5E5"> the</font><font color="#CCCCCC"> dryer dry I most of</font> the patients I saw had some evidence<font color="#CCCCCC"> of</font> dry<font color="#CCCCCC"> eye beyond</font><font color="#E5E5E5"> just the symptoms whether</font> it was an unstable tear<font color="#CCCCCC"> film a rapid</font> <font color="#E5E5E5">breakup time of the tears but more often</font> <font color="#E5E5E5">staining of the ocular surface with</font>

vital<font color="#E5E5E5"> dyes because</font><font color="#CCCCCC"> they most most of</font><font color="#E5E5E5"> the</font> time<font color="#E5E5E5"> unless</font><font color="#CCCCCC"> the patient</font><font color="#E5E5E5"> had staining of</font> <font color="#CCCCCC">the ocular surface</font><font color="#E5E5E5"> they didn't get</font> referred to<font color="#CCCCCC"> me they were managed by by</font> their<font color="#CCCCCC"> local doctors</font><font color="#E5E5E5"> okay so when they</font> get referred<font color="#CCCCCC"> to you and is it fair to</font>

say<font color="#E5E5E5"> that they've already tried all these</font> sort of OTC the artificial tryptase lubricants<font color="#E5E5E5"> or is that where you would</font> <font color="#E5E5E5">start with</font><font color="#CCCCCC"> some of the treatment</font><font color="#E5E5E5"> so if</font> you<font color="#CCCCCC"> just</font><font color="#E5E5E5"> told me</font><font color="#CCCCCC"> that you want once</font> you've got one<font color="#CCCCCC"> of these for their</font>

<font color="#E5E5E5">patients how you would approach the</font> treatment yes and the the the approach was basically a graded approach based on <font color="#CCCCCC">a severity</font><font color="#E5E5E5"> of disease as assessed by</font><font color="#CCCCCC"> a</font> <font color="#E5E5E5">both symptoms and signs so and that's</font> you<font color="#CCCCCC"> may or may not be</font><font color="#E5E5E5"> familiar with the</font>

<font color="#CCCCCC">do's report the dry eye workshop report</font> <font color="#E5E5E5">of 2007 yes</font><font color="#CCCCCC"> yes that yeah well I was one</font> <font color="#CCCCCC">of the</font><font color="#E5E5E5"> participants in that</font><font color="#CCCCCC"> workshop</font><font color="#E5E5E5"> and</font> I tended to follow the<font color="#E5E5E5"> recommendations</font> of the dry eye workshop with regard to severity graded treatment and the

routine<font color="#E5E5E5"> was generally again artificial</font> tear lubricants but when they got<font color="#E5E5E5"> to</font><font color="#CCCCCC"> me</font> <font color="#E5E5E5">I would</font><font color="#CCCCCC"> oftentimes be evaluating both</font> for evidence of not only<font color="#E5E5E5"> aqueous</font> deficient productive and production deficiency but also the my<font color="#CCCCCC"> bohmian gland</font>

dysfunction<font color="#E5E5E5"> aspect of dry eye so I would</font> typically if they were on<font color="#E5E5E5"> artificial</font> tears and they had evidence<font color="#E5E5E5"> of my</font> <font color="#E5E5E5">bohmian gland dysfunction</font><font color="#CCCCCC"> I would</font> sometimes<font color="#E5E5E5"> art</font> <font color="#E5E5E5">alter</font><font color="#CCCCCC"> chart officials here they were</font><font color="#E5E5E5"> on</font>

and begin a routine<font color="#E5E5E5"> of live</font><font color="#CCCCCC"> Messiah</font><font color="#E5E5E5"> hot</font> compress and rib massage and if that then worked and resolved the issues then <font color="#CCCCCC">we would just stick with</font><font color="#E5E5E5"> that</font><font color="#CCCCCC"> if indeed</font> they were more severe and had a little or no response to<font color="#CCCCCC"> the to the meibomian</font>

gland treatment and had<font color="#E5E5E5"> evidence still</font> abstaining<font color="#CCCCCC"> I would move to</font><font color="#E5E5E5"> one of two</font> treatments<font color="#E5E5E5"> either topical cyclosporine</font> <font color="#CCCCCC">wrist ASIS as an anti-inflammatory or</font> <font color="#E5E5E5">oral doxycycline for treatment of their</font> my<font color="#CCCCCC"> bohmian</font><font color="#E5E5E5"> gland is disease nowadays in</font>

the u.s. not only<font color="#CCCCCC"> is cyclosporine</font> considered at that<font color="#E5E5E5"> stage</font><font color="#CCCCCC"> but also zadra</font> any the photographs<font color="#E5E5E5"> treatment if those</font> things fail<font color="#E5E5E5"> then I would move</font><font color="#CCCCCC"> to</font> autologous serum treatment<font color="#E5E5E5"> where I would</font> <font color="#CCCCCC">actually</font><font color="#E5E5E5"> draw blood from the patient's</font>

vein<font color="#E5E5E5"> spin it down and use the serum</font> diluted to a<font color="#CCCCCC"> ten percent</font><font color="#E5E5E5"> concentration</font> <font color="#E5E5E5">and have the patient apply that drop</font> <font color="#E5E5E5">three or four times a day okay</font><font color="#CCCCCC"> so</font> anything<font color="#CCCCCC"> that</font><font color="#E5E5E5"> was kind of the routine so</font> when it comes to stasis and<font color="#E5E5E5"> sitter I</font>

mean they are<font color="#E5E5E5"> high-priced treatments so</font> very what<font color="#E5E5E5"> percentage of patients and</font> you've been in<font color="#E5E5E5"> both this of general</font> <font color="#CCCCCC">practice and the specialist practice</font> what sort of percent of patients<font color="#E5E5E5"> would</font> you say would<font color="#E5E5E5"> be happy</font><font color="#CCCCCC"> with the more OTC</font>

type products and what percent would need to<font color="#E5E5E5"> move on to to these more</font> advanced<font color="#E5E5E5"> products probably 60% of the</font> patients<font color="#CCCCCC"> which mild dry</font><font color="#E5E5E5"> I would notice</font> improvement with<font color="#E5E5E5"> artificial tear and</font> lived<font color="#E5E5E5"> the management of the</font><font color="#CCCCCC"> lid my</font>

<font color="#CCCCCC">Bamiyan gland problem</font> the 50%<font color="#E5E5E5"> that that didn't respond and</font> that had<font color="#CCCCCC"> to go on to potentially rest</font> <font color="#CCCCCC">ASIS my experience was that 10% of</font><font color="#E5E5E5"> those</font> patients<font color="#E5E5E5"> would not tolerate</font><font color="#CCCCCC"> the stasis</font> <font color="#CCCCCC">hmm a</font><font color="#E5E5E5"> number of them obviously couldn't</font>

afford it<font color="#CCCCCC"> so they did not to use it of</font> the patients who stayed<font color="#E5E5E5"> on the</font><font color="#CCCCCC"> wrist</font> <font color="#E5E5E5">ASIS about 75% of them would show some</font> <font color="#E5E5E5">improvement</font><font color="#CCCCCC"> to some</font><font color="#E5E5E5"> degree in symptom</font> sign or both<font color="#E5E5E5"> so there was 25 percent of</font> the patients<font color="#E5E5E5"> on</font><font color="#CCCCCC"> row stasis that did not</font>

have a significant<font color="#E5E5E5"> improvement and those</font> are the ones<font color="#CCCCCC"> that we often ended up</font> going<font color="#E5E5E5"> to autologous serum okay</font><font color="#CCCCCC"> at least</font> patients of the<font color="#E5E5E5"> 25%</font><font color="#CCCCCC"> they the ones</font><font color="#E5E5E5"> that</font> manage<font color="#CCCCCC"> to take it for the several months</font> <font color="#CCCCCC">is it 2 or 3</font><font color="#E5E5E5"> months it takes to take the</font>

full effect right<font color="#E5E5E5"> 3</font><font color="#CCCCCC"> 3 months was the</font> <font color="#E5E5E5">minimum that I I would count</font><font color="#CCCCCC"> towards</font><font color="#E5E5E5"> the</font> end of my<font color="#CCCCCC"> career when</font><font color="#E5E5E5"> I was using</font> <font color="#E5E5E5">osmolality excuse me oz molarity testing</font> as a response indicator<font color="#E5E5E5"> if they'd been</font> <font color="#E5E5E5">on row stasis for a month with no</font>

improvement<font color="#E5E5E5"> in their osmolarity</font><font color="#CCCCCC"> I would</font> <font color="#CCCCCC">often times move to the next</font><font color="#E5E5E5"> treatment</font> <font color="#CCCCCC">right okay what was the basis well</font> <font color="#CCCCCC">digger's</font><font color="#E5E5E5"> only just approved and so</font><font color="#CCCCCC"> am</font><font color="#E5E5E5"> I</font> <font color="#E5E5E5">mean have you got any feel</font><font color="#CCCCCC"> for the</font> difference now<font color="#CCCCCC"> with zero and the status</font>

which<font color="#E5E5E5"> one's going to be</font><font color="#CCCCCC"> the better</font> treatment or are they<font color="#CCCCCC"> complementary or</font> <font color="#CCCCCC">just alternatives well buckle</font><font color="#E5E5E5"> and I have</font> to<font color="#E5E5E5"> answer from a couple of perspectives</font> <font color="#CCCCCC">with regard to response the response to</font> zebra is quicker than is risque<font color="#CCCCCC"> psious</font>

and it is tolerated a little better<font color="#E5E5E5"> from</font> <font color="#E5E5E5">the standpoint of stinging of the</font> surface some<font color="#E5E5E5"> patients will</font> notice<font color="#CCCCCC"> disturbing change in their</font><font color="#E5E5E5"> taste</font> <font color="#E5E5E5">and so they opted not to continue this</font> <font color="#CCCCCC">idea but</font><font color="#E5E5E5"> in general I think the</font><font color="#CCCCCC"> ziege</font>

<font color="#E5E5E5">has a quicker response</font><font color="#CCCCCC"> if it is going</font><font color="#E5E5E5"> to</font> work<font color="#E5E5E5"> it is</font><font color="#CCCCCC"> not clear what the</font><font color="#E5E5E5"> magnitude</font> <font color="#CCCCCC">of effect is in the trials where they</font> reached<font color="#CCCCCC"> us approval</font><font color="#E5E5E5"> the the benefit was</font> relatively<font color="#CCCCCC"> small but sufficient for</font> approval<font color="#CCCCCC"> so from</font><font color="#E5E5E5"> that from an efficacy</font>

standpoint<font color="#E5E5E5"> desire should be quicker</font><font color="#CCCCCC"> in</font> response<font color="#E5E5E5"> should have</font><font color="#CCCCCC"> a better acceptance</font> by<font color="#E5E5E5"> the patient</font><font color="#CCCCCC"> but may have</font><font color="#E5E5E5"> as modest of</font> responses<font color="#E5E5E5"> or stasis debts now from the</font> <font color="#E5E5E5">other perspective is from a</font> reimbursement standpoint<font color="#E5E5E5"> they're both</font>

<font color="#E5E5E5">expensive mistakes is approved for</font> reimbursement by<font color="#E5E5E5"> kind of most insurance</font> companies<font color="#E5E5E5"> albeit at a fairly high copay</font> level as I drew<font color="#E5E5E5"> at present is not</font> <font color="#E5E5E5">accepted by or covered by a lot of the</font> <font color="#CCCCCC">healthcare</font><font color="#E5E5E5"> programs so it's going to</font>

<font color="#E5E5E5">take a little time</font><font color="#CCCCCC"> for zebra to reach</font> the<font color="#CCCCCC"> level of acceptance and</font> <font color="#E5E5E5">reimbursement that wrist</font><font color="#CCCCCC"> asus has</font><font color="#E5E5E5"> right</font> now have<font color="#E5E5E5"> you got any</font><font color="#CCCCCC"> choice about how</font> long that<font color="#CCCCCC"> will take</font> oh just<font color="#E5E5E5"> at least six months maybe longer</font>

<font color="#CCCCCC">if</font><font color="#E5E5E5"> you say versus if there's quite a</font> high copay<font color="#CCCCCC"> and what sort</font><font color="#E5E5E5"> of percentage</font> <font color="#E5E5E5">of patients and that you would normally</font> want<font color="#CCCCCC"> to put</font><font color="#E5E5E5"> onto a stasis</font><font color="#CCCCCC"> and do you</font> think would turn it down<font color="#CCCCCC"> or just not be</font> <font color="#E5E5E5">able to go ahead because</font><font color="#CCCCCC"> of the</font>

financials of it is it a really significant factor well that depends upon their insurance<font color="#E5E5E5"> coverage</font><font color="#CCCCCC"> I mean</font><font color="#E5E5E5"> it</font> you know<font color="#E5E5E5"> the cost of</font><font color="#CCCCCC"> the side</font><font color="#E5E5E5"> remember</font> stasis for<font color="#E5E5E5"> an equal amount of time care</font> basically<font color="#CCCCCC"> one month is the same so</font>

<font color="#CCCCCC">seven hundred dollars</font><font color="#E5E5E5"> seven to eight</font> hundred<font color="#E5E5E5"> dollars excuse me</font> most<font color="#E5E5E5"> good insurance programs will</font> reimburse the cost of<font color="#E5E5E5"> wrist</font><font color="#CCCCCC"> asus2</font> around<font color="#CCCCCC"> fifty dollars a month all</font><font color="#E5E5E5"> right</font> okay<font color="#CCCCCC"> oh and they probably will</font><font color="#E5E5E5"> end up</font>

doing<font color="#CCCCCC"> about</font><font color="#E5E5E5"> the</font><font color="#CCCCCC"> same for zebra I would</font> expect but if someone has no insurance coverage<font color="#CCCCCC"> then they're unlikely to want</font> <font color="#E5E5E5">to spend seven to eight</font><font color="#CCCCCC"> hundred dollars</font> a month<font color="#E5E5E5"> for the drug so in terms of</font> other<font color="#CCCCCC"> things that</font><font color="#E5E5E5"> might limit whether or</font>

not you would<font color="#E5E5E5"> be happy to prescribe a</font> status<font color="#E5E5E5"> as a juror is there anything</font> I mean you've mentioned that there's <font color="#E5E5E5">limited efficacy and have you seen</font> <font color="#E5E5E5">anything else that would would make you</font> <font color="#E5E5E5">want</font><font color="#CCCCCC"> to keep this in reserve for really</font>

severe patients such as society you've mentioned some side effects are there <font color="#E5E5E5">any other from a practitioner point of</font> view any other concerns with these drugs no not<font color="#CCCCCC"> really</font> that the part of<font color="#CCCCCC"> the</font><font color="#E5E5E5"> issue that</font><font color="#CCCCCC"> comes up</font>

with<font color="#E5E5E5"> risque</font><font color="#CCCCCC"> --ss is that even the</font> patients who have a response<font color="#E5E5E5"> favorable</font> response<font color="#CCCCCC"> long-term can</font><font color="#E5E5E5"> have what are</font> called breakthrough<font color="#CCCCCC"> or flare-ups</font><font color="#E5E5E5"> of</font> symptoms and<font color="#CCCCCC"> those patients</font><font color="#E5E5E5"> typically</font> what we do is<font color="#CCCCCC"> we treat</font><font color="#E5E5E5"> that flare-up</font>

<font color="#CCCCCC">with</font><font color="#E5E5E5"> topical corticosteroids but as you</font> probably know there are<font color="#E5E5E5"> problems with</font> <font color="#CCCCCC">corticosteroids side effects of elevated</font> <font color="#CCCCCC">and rockateur pressure long-term use can</font> lead to cataract<font color="#CCCCCC"> formation and there is</font> a potential risk<font color="#E5E5E5"> of infection</font><font color="#CCCCCC"> so most of</font>

<font color="#E5E5E5">the time you're limiting the treatment</font> with<font color="#E5E5E5"> the corticosteroids</font><font color="#CCCCCC"> to two or</font><font color="#E5E5E5"> three</font> weeks at a time<font color="#E5E5E5"> and then once the</font> episode<font color="#E5E5E5"> or flare-up is broken</font><font color="#CCCCCC"> you just</font> <font color="#CCCCCC">keep on</font><font color="#E5E5E5"> with their stasis</font> <font color="#E5E5E5">and I assume</font><font color="#CCCCCC"> Zeigler will have a similar</font>

response so the patient<font color="#E5E5E5"> is taking a safe</font> this do they also tend to<font color="#E5E5E5"> use the</font><font color="#CCCCCC"> the</font> tears or lubricants at the same time<font color="#CCCCCC"> or</font> is<font color="#E5E5E5"> it just one treatment of</font><font color="#CCCCCC"> nine no</font> they're usually they usually will use because<font color="#CCCCCC"> the race basis is only used once</font>

excuse me typically<font color="#E5E5E5"> twice a day</font><font color="#CCCCCC"> patients still you</font> end up using or meeting lubricants artificial tears so in the US with the <font color="#E5E5E5">lubricants and is that something a</font> patient tends to pay for<font color="#CCCCCC"> themselves or</font>

is that<font color="#CCCCCC"> true insurance as well no</font> insurance<font color="#E5E5E5"> doesn't cover the over the</font> counters so the patient is paying<font color="#E5E5E5"> for</font> those<font color="#E5E5E5"> out-of-pocket okay that's</font><font color="#CCCCCC"> on my</font> <font color="#E5E5E5">question yes if those that can be bought</font> OTC<font color="#E5E5E5"> is that a general thing in the u.s.</font>

though that if it can<font color="#E5E5E5"> be bought OTC</font> there's no way for<font color="#CCCCCC"> an insurer to car it</font> <font color="#E5E5E5">right okay</font><font color="#CCCCCC"> exactly yeah and that that</font> would<font color="#CCCCCC"> be tha that would be the biggest</font> issue with<font color="#CCCCCC"> lamellas all but they're</font> actually<font color="#E5E5E5"> going to go for our X but I've</font>

got the question or they are<font color="#E5E5E5"> and they</font> are<font color="#E5E5E5"> but there's also from the product</font> profile you've seen<font color="#E5E5E5"> that</font><font color="#CCCCCC"> it puts</font> <font color="#CCCCCC">wave-around I'm sitting my lights have</font> <font color="#CCCCCC">gone off because</font><font color="#E5E5E5"> it's been well</font> certainly big Canada and UK<font color="#E5E5E5"> it's been</font>

<font color="#E5E5E5">accepted to be registered as a device in</font> the<font color="#E5E5E5"> u.s. it's actually with the office</font> <font color="#E5E5E5">of combination products to decide</font> whether<font color="#E5E5E5"> or not it can be registered</font><font color="#CCCCCC"> as a</font> de novo device or whether<font color="#E5E5E5"> or not it does</font> have to<font color="#E5E5E5"> go the drug route so I do</font>

<font color="#CCCCCC">actually</font><font color="#E5E5E5"> have some other questions</font><font color="#CCCCCC"> but</font> firstly<font color="#CCCCCC"> just finishing off</font><font color="#E5E5E5"> a little</font> <font color="#CCCCCC">cazali phone they have</font><font color="#E5E5E5"> based on the</font> target profile you sent me<font color="#CCCCCC"> I would</font> expect that<font color="#E5E5E5"> the the FDA would consider</font> it as a pharmaceutical rather than a

device yes that is a<font color="#E5E5E5"> little</font><font color="#CCCCCC"> bitter</font><font color="#E5E5E5"> sterile</font> <font color="#CCCCCC">preservative-free I</font><font color="#E5E5E5"> drop</font><font color="#CCCCCC"> work for the</font> treatment of dry eye<font color="#E5E5E5"> it is and these</font><font color="#CCCCCC"> are</font> the discussions<font color="#E5E5E5"> that are being had at</font> the moment

about trying to<font color="#E5E5E5"> prove</font><font color="#CCCCCC"> that it's a purely</font> by a<font color="#E5E5E5"> physical mechanism of action rather</font> than actually having<font color="#E5E5E5"> a pharmacological</font> mechanism of action and that<font color="#CCCCCC"> is</font><font color="#E5E5E5"> they</font> that actually is<font color="#CCCCCC"> the nature of the</font> ongoing<font color="#E5E5E5"> discussion</font><font color="#CCCCCC"> with the FDA I mean</font>

in the in the UK<font color="#CCCCCC"> and Canada they</font><font color="#E5E5E5"> have</font> accepted that<font color="#E5E5E5"> it's biophysical so</font><font color="#CCCCCC"> they</font> can be registered<font color="#E5E5E5"> as a device</font><font color="#CCCCCC"> oh very</font> interesting<font color="#E5E5E5"> is that you know the</font> <font color="#CCCCCC">description as lipid viscid vesicles is</font> somewhat comparable to some of the

pharmaceutical delivery systems<font color="#CCCCCC"> that are</font> being<font color="#E5E5E5"> evaluated right now in the</font><font color="#CCCCCC"> US yes</font> we should get an answer<font color="#CCCCCC"> and of course</font> <font color="#CCCCCC">three</font><font color="#E5E5E5"> this</font><font color="#CCCCCC"> year</font><font color="#E5E5E5"> how the US are going to</font> view<font color="#E5E5E5"> this and I mean in the UK it was</font> <font color="#E5E5E5">based on the fact that the exact term is</font>

<font color="#CCCCCC">two in</font><font color="#E5E5E5"> one</font><font color="#CCCCCC"> also uses soy phospholipids</font> <font color="#E5E5E5">so they managed to argue that that's an</font> OTC product<font color="#CCCCCC"> actually in the in the</font><font color="#E5E5E5"> UK so</font> that's how it managed to<font color="#E5E5E5"> get registered</font> as a device<font color="#E5E5E5"> saving or registry yes so</font> with the existing products out there<font color="#CCCCCC"> and</font>

apart from sort cost side effects are there any other limitations and<font color="#E5E5E5"> that</font><font color="#CCCCCC"> you</font> can think of and we do thing for<font color="#CCCCCC"> no</font> those<font color="#CCCCCC"> yeah obviously for the over the</font> counters that contain a preservative <font color="#CCCCCC">there there's always a</font><font color="#E5E5E5"> risk of</font>

preservative toxicity or allergic response but for the preservative free drops that's usually not not an<font color="#E5E5E5"> issue</font><font color="#CCCCCC"> there</font><font color="#E5E5E5"> are a</font><font color="#CCCCCC"> number of</font> over-the-counter<font color="#E5E5E5"> drops in the</font><font color="#CCCCCC"> u.s. that</font> contain lipids<font color="#E5E5E5"> as part of their</font>

component formula the<font color="#CCCCCC"> they generally are</font> considered as an enhanced artificial <font color="#E5E5E5">tear and generally are available at a</font> higher higher price<font color="#E5E5E5"> but the again they</font> generally only<font color="#CCCCCC"> contain some type of a</font>

lubricant vehicle and then the additional lipid<font color="#E5E5E5"> hmm and will be this</font> <font color="#CCCCCC">and</font><font color="#E5E5E5"> gone to any sort of clinical trials</font> <font color="#E5E5E5">no</font><font color="#CCCCCC"> yeah</font><font color="#E5E5E5"> right well they</font><font color="#CCCCCC"> they all they</font> have to they<font color="#CCCCCC"> have to meet</font><font color="#E5E5E5"> certain FDA</font> requirements in terms<font color="#E5E5E5"> of you know</font>

<font color="#CCCCCC">quality control and if other other</font> stability<font color="#E5E5E5"> issues but there generally is</font> no requirement<font color="#CCCCCC"> for a separate specific</font> registered clinical<font color="#E5E5E5"> trial in order for</font> them to be<font color="#E5E5E5"> approved they're approved</font> under what's called<font color="#CCCCCC"> the monograph which</font>

<font color="#E5E5E5">lists a variety</font><font color="#CCCCCC"> of different things</font> components and excipient that can be added<font color="#CCCCCC"> to a topical eyedrop application</font> and they get approved<font color="#E5E5E5"> under the of the</font> the<font color="#CCCCCC"> monograph</font><font color="#E5E5E5"> but if it contains you</font> know there is one one<font color="#E5E5E5"> drug that's in</font>

testing and dry<font color="#CCCCCC"> eye now that is a</font> delivery<font color="#E5E5E5"> system</font><font color="#CCCCCC"> for a topical steroid</font> <font color="#E5E5E5">but the delivery system itself would</font><font color="#CCCCCC"> not</font> have to<font color="#E5E5E5"> be evaluated in a clinical trial</font> but because it contains the steroid as a pharmaceutical<font color="#E5E5E5"> it has to be</font><font color="#CCCCCC"> evaluated in</font>

phase<font color="#E5E5E5"> three clinical trials pivotal</font> clinical trials<font color="#E5E5E5"> okay</font><font color="#CCCCCC"> this is</font><font color="#E5E5E5"> a micro</font> it's a micro<font color="#E5E5E5"> formula that that allows</font> higher delivery of the drug to<font color="#CCCCCC"> the eye</font> through the<font color="#E5E5E5"> tear</font><font color="#CCCCCC"> film okay in terms</font><font color="#E5E5E5"> of</font> <font color="#E5E5E5">the the lipid containing enhanced tears</font>

<font color="#E5E5E5">if they get</font><font color="#CCCCCC"> proved</font><font color="#E5E5E5"> just on a monograph</font> <font color="#E5E5E5">have most of these companies done some</font> <font color="#E5E5E5">sort of clinical testing to</font><font color="#CCCCCC"> show</font> efficacy for marketing purposes<font color="#CCCCCC"> or is</font><font color="#E5E5E5"> it</font> <font color="#CCCCCC">really a brand in the market itself the</font> uptake is that really driven<font color="#E5E5E5"> by</font><font color="#CCCCCC"> the the</font>

marketing power of the company<font color="#CCCCCC"> behind</font> them yes it's<font color="#E5E5E5"> predominantly the</font> marketing power<font color="#CCCCCC"> and that's why you'll</font> see<font color="#CCCCCC"> that that when there's a new</font> additive they will<font color="#E5E5E5"> concentrate on the</font> new additive<font color="#E5E5E5"> a good example of that was</font>

<font color="#CCCCCC">the sustained drop</font><font color="#E5E5E5"> from alcone</font><font color="#CCCCCC"> sustain</font> was a well recognized and well used artificial<font color="#E5E5E5"> tear but when they moved it</font> and enhanced it with the lipid containing component they marketed as what's called<font color="#CCCCCC"> sustained balance and that</font>

was done<font color="#CCCCCC"> under the</font><font color="#E5E5E5"> monograph and is</font> marketed<font color="#CCCCCC"> at a higher higher cost and in</font> your experience<font color="#CCCCCC"> how they got higher</font> efficacy or<font color="#E5E5E5"> is it a marketing and</font> success<font color="#CCCCCC"> it yes</font><font color="#E5E5E5"> it depends upon the</font><font color="#CCCCCC"> the</font> <font color="#CCCCCC">nature of the</font><font color="#E5E5E5"> patient's dry</font><font color="#CCCCCC"> eye</font><font color="#E5E5E5"> if they</font>

have significant my<font color="#CCCCCC"> Bamiyan gland</font> dysfunction<font color="#E5E5E5"> it seems to make a</font> <font color="#E5E5E5">difference it seems to work better for</font> the standard aqueous deficient dry<font color="#E5E5E5"> eye I</font> didn't notice that<font color="#E5E5E5"> it that it really</font> <font color="#E5E5E5">made that</font><font color="#CCCCCC"> much of a difference but for</font>

<font color="#E5E5E5">the lipid deficient dry eye it seemed to</font> have a better effect<font color="#E5E5E5"> thank you it</font><font color="#CCCCCC"> it in</font> <font color="#E5E5E5">terms of the percentage of patients</font><font color="#CCCCCC"> once</font> you've gone with each patient gone through<font color="#E5E5E5"> though the whole cascade of</font> treatments what sort of percentage of

patients<font color="#CCCCCC"> do</font><font color="#E5E5E5"> you think are happy with</font> the outcome<font color="#E5E5E5"> it might have taken a while</font> <font color="#CCCCCC">to get there but whatever there they</font> finally prescribed that if they're happy <font color="#E5E5E5">with and the results are getting well</font> that kind of depends on the severity of

<font color="#E5E5E5">the dry eye the mild to moderate dry eye</font> patients<font color="#E5E5E5"> generally do fairly well</font><font color="#CCCCCC"> with</font> whatever<font color="#E5E5E5"> final</font><font color="#CCCCCC"> combination works for</font> them be it<font color="#CCCCCC"> artificial tears</font><font color="#E5E5E5"> wrists ASIS</font> <font color="#CCCCCC">or</font><font color="#E5E5E5"> ziege or</font><font color="#CCCCCC"> puncta plugs which</font><font color="#E5E5E5"> are the</font> other device that's<font color="#CCCCCC"> used to retain tears</font>

on the other hand<font color="#CCCCCC"> the moderate to</font><font color="#E5E5E5"> severe</font> group<font color="#E5E5E5"> they oftentimes don't</font><font color="#CCCCCC"> have as</font> favorable response<font color="#E5E5E5"> and typically are</font> using<font color="#E5E5E5"> wrists ASIS I drew and have had</font> <font color="#CCCCCC">Ponca plugging and obviously</font><font color="#E5E5E5"> a group of</font> those go<font color="#E5E5E5"> on to autologous serum</font>

treatment now that I had some<font color="#CCCCCC"> patients</font> who had particularly<font color="#E5E5E5"> those with children</font> syndrome<font color="#E5E5E5"> who had dramatic response to</font> autologous serum<font color="#E5E5E5"> even though they didn't</font> respond terribly well to<font color="#CCCCCC"> the</font><font color="#E5E5E5"> stasis</font> <font color="#E5E5E5">ziege hadn't come along</font><font color="#CCCCCC"> by that time but</font>

so it kind of depended upon the nature <font color="#E5E5E5">of the</font><font color="#CCCCCC"> disease</font><font color="#E5E5E5"> Sjogren's tends to be</font> more difficult<font color="#E5E5E5"> to treat than the regular</font> run-of-the-mill<font color="#E5E5E5"> aqueous deficient</font> meibomian gland dysfunction patients<font color="#E5E5E5"> but</font> within anti-inflammatory therapy<font color="#E5E5E5"> the the</font>

<font color="#CCCCCC">Shogun's patients require more more</font><font color="#E5E5E5"> of</font> that treatment<font color="#E5E5E5"> and generally still don't</font> have the full comfort response that<font color="#CCCCCC"> the</font> other patients do it autologous theorem is that reimbursed<font color="#E5E5E5"> and</font><font color="#CCCCCC"> there it's made</font> on a patient by patient basis but do

<font color="#E5E5E5">insurers cover that the cost of that</font> not generally<font color="#CCCCCC"> no and the there is a push</font> <font color="#E5E5E5">to</font><font color="#CCCCCC"> get it to be to be</font><font color="#E5E5E5"> covered but right</font> now I do not believe<font color="#CCCCCC"> that it is covered</font> by<font color="#CCCCCC"> insurance</font> <font color="#E5E5E5">okay and so if another actually listen</font>

moving slightly into the<font color="#E5E5E5"> lamellae</font> product and if another product<font color="#E5E5E5"> was</font> approved<font color="#E5E5E5"> and that</font><font color="#CCCCCC"> could be used as well</font> <font color="#CCCCCC">as</font><font color="#E5E5E5"> rest ASIS what's your feel for the</font> reimbursement<font color="#E5E5E5"> would you I mean</font><font color="#CCCCCC"> with</font> insurers<font color="#CCCCCC"> would they be likely to</font><font color="#E5E5E5"> approve</font>

reimbursement of and to product I mean that would<font color="#CCCCCC"> obviously make it very</font> expensive on a patient<font color="#E5E5E5"> monthly treatment</font> <font color="#CCCCCC">cost is that</font><font color="#E5E5E5"> an issue for</font><font color="#CCCCCC"> the insurers</font> <font color="#E5E5E5">or is it</font><font color="#CCCCCC"> just if a product</font><font color="#E5E5E5"> individually</font> is approved for<font color="#E5E5E5"> reimbursement</font><font color="#CCCCCC"> a patient</font>

can actually have<font color="#CCCCCC"> over</font><font color="#E5E5E5"> fought for for an</font> equivalent<font color="#E5E5E5"> of an artificial tear</font><font color="#CCCCCC"> I don't</font> <font color="#E5E5E5">think the</font><font color="#CCCCCC"> insurance companies would</font> cover now if you if it were demonstrated that there were<font color="#E5E5E5"> a there was a</font> significant clinical<font color="#E5E5E5"> response and</font>

benefit compared to a stasis<font color="#E5E5E5"> or zadra</font> <font color="#E5E5E5">then I think with with that</font><font color="#CCCCCC"> FDA blessing</font> <font color="#CCCCCC">it might be</font><font color="#E5E5E5"> considered for reimbursement</font> by some of the insurers but<font color="#CCCCCC"> if it if it</font> were something<font color="#CCCCCC"> that</font><font color="#E5E5E5"> we're going to</font><font color="#CCCCCC"> eat</font> <font color="#E5E5E5">with high-end lubricant dry eye</font>

treatments<font color="#CCCCCC"> I don't</font><font color="#E5E5E5"> think it would get</font> approval for<font color="#E5E5E5"> a reimbursement</font><font color="#CCCCCC"> yeah</font><font color="#E5E5E5"> I mean</font> the the<font color="#E5E5E5"> positioning that lamella is</font> hoping<font color="#CCCCCC"> for this product</font><font color="#E5E5E5"> is even though</font> it on the description<font color="#CCCCCC"> it might at first</font> <font color="#E5E5E5">glance look like an advanced here</font>

<font color="#E5E5E5">because of the science</font><font color="#CCCCCC"> behind it</font><font color="#E5E5E5"> and</font> they are<font color="#E5E5E5"> seeing is an advanced product</font> <font color="#E5E5E5">that would hopefully potentially be used</font> before<font color="#CCCCCC"> wrist ASIS or Sidra</font><font color="#E5E5E5"> and</font> potentially prevent patients from<font color="#CCCCCC"> having</font> to go<font color="#CCCCCC"> onto</font><font color="#E5E5E5"> those</font>

and drugs and but I'd like<font color="#CCCCCC"> to want I'd</font> like<font color="#CCCCCC"> to</font><font color="#E5E5E5"> get your opinion</font><font color="#CCCCCC"> on the</font> positioning<font color="#E5E5E5"> and what you've read</font><font color="#CCCCCC"> about</font> the target product profile but<font color="#CCCCCC"> also if</font> it was<font color="#E5E5E5"> approved as a device</font><font color="#CCCCCC"> I mean</font><font color="#E5E5E5"> that</font> <font color="#E5E5E5">is says in the profile they are doing</font>

clinical<font color="#CCCCCC"> trials so fingers crossed they</font> will get<font color="#E5E5E5"> some efficacy data just the</font> approval<font color="#E5E5E5"> otherwise you'll have a bearing</font> on<font color="#E5E5E5"> the</font><font color="#CCCCCC"> investment</font><font color="#E5E5E5"> oh it would yeah but</font> to be<font color="#CCCCCC"> perfectly frank</font><font color="#E5E5E5"> the when I see the</font> <font color="#CCCCCC">mechanism of action</font><font color="#E5E5E5"> as described in the</font>

target product product profile<font color="#CCCCCC"> the</font> <font color="#E5E5E5">emphasis on biophysical effect</font><font color="#CCCCCC"> many of</font> the<font color="#E5E5E5"> artificial tears particularly that</font> <font color="#E5E5E5">the more advanced and sophisticated</font> <font color="#E5E5E5">artificial tears available in the</font><font color="#CCCCCC"> u.s.</font> function in a biophysical manner<font color="#E5E5E5"> their</font>

physical properties<font color="#CCCCCC"> are justified by</font> <font color="#E5E5E5">their effect on the biology of</font><font color="#CCCCCC"> the</font> ocular surface for the tear<font color="#CCCCCC"> film</font><font color="#E5E5E5"> so I</font> would in order<font color="#E5E5E5"> to be convinced that this</font> <font color="#CCCCCC">is something that would</font><font color="#E5E5E5"> be approvable as</font> a device<font color="#CCCCCC"> I would</font><font color="#E5E5E5"> expect to</font><font color="#CCCCCC"> see a very</font>

strong demonstration<font color="#CCCCCC"> of effectiveness</font> <font color="#E5E5E5">not just the claim that it's a</font> biophysical response what sort of clinical results that<font color="#CCCCCC"> even</font><font color="#E5E5E5"> have that clinical trial to</font> <font color="#E5E5E5">the program in front of me but what sort</font>

of<font color="#CCCCCC"> clinical results would you expect see</font> <font color="#CCCCCC">for a product that would</font><font color="#E5E5E5"> be considered a</font> sort of advanced<font color="#E5E5E5"> treatment on a path or</font> before with stasis or<font color="#CCCCCC"> Sidra on the basis</font> of what the FDA would suspect expect or what I what I would<font color="#CCCCCC"> want to see high if</font>

<font color="#CCCCCC">they differ</font><font color="#E5E5E5"> and your opinion on both</font> would be<font color="#E5E5E5"> great yeah well they do differ</font> <font color="#E5E5E5">because for me it would be to</font><font color="#CCCCCC"> be able</font><font color="#E5E5E5"> to</font> demonstrate<font color="#E5E5E5"> an increase first of all</font> symptomatic benefit in the moderate at least the<font color="#E5E5E5"> moderate</font>

<font color="#E5E5E5">severe patient that demonstrated benefit</font> in tear film stability<font color="#E5E5E5"> determined by</font> <font color="#CCCCCC">what ever ever</font><font color="#E5E5E5"> it's to break up time or</font> <font color="#CCCCCC">biome come</font><font color="#E5E5E5"> optical measurements of</font> stability<font color="#E5E5E5"> of the</font><font color="#CCCCCC"> reduction in corneal</font> and conjunctival<font color="#E5E5E5"> overall ocular surface</font>

<font color="#E5E5E5">staining and ideally if there were in</font> patients who had some inflammation<font color="#E5E5E5"> in</font> the eye a reduction in the inflammation <font color="#CCCCCC">those would be</font><font color="#E5E5E5"> the three signs I would</font> want to<font color="#CCCCCC"> see in</font><font color="#E5E5E5"> addition to improvement</font> <font color="#E5E5E5">in comfort now from what the FDA would</font>

require is they would expect<font color="#E5E5E5"> or want to</font> see improvement<font color="#E5E5E5"> in symptoms</font> <font color="#CCCCCC">statistically demonstrated for this over</font> a control topical preparation<font color="#CCCCCC"> in other</font> words of an artificial<font color="#CCCCCC"> tariffs</font><font color="#E5E5E5"> a</font> lubricant<font color="#E5E5E5"> of some type</font><font color="#CCCCCC"> improvement in</font>

again<font color="#E5E5E5"> either</font><font color="#CCCCCC"> a sign</font><font color="#E5E5E5"> of some type and</font> <font color="#E5E5E5">they would probably</font><font color="#CCCCCC"> expect a tear film</font> stability increase improvement in ocular surface<font color="#CCCCCC"> Taney and they probably wouldn't</font> <font color="#E5E5E5">require an improvement in inflammation</font> <font color="#E5E5E5">although they certainly would accept</font>

<font color="#CCCCCC">that I</font><font color="#E5E5E5"> think as one of the responses and</font> their requirement would<font color="#E5E5E5"> be a statistical</font> difference<font color="#E5E5E5"> between the lamellae versus</font> whatever<font color="#E5E5E5"> control was used mm-hmm</font> they were not the<font color="#E5E5E5"> FDA would not require</font> a head-to-head comparison<font color="#CCCCCC"> with risk ASIS</font>

or<font color="#E5E5E5"> ziege</font><font color="#CCCCCC"> I think from the description</font> that I see here<font color="#E5E5E5"> they would accept a</font> statistical improvement beyond a lubricant drop<font color="#CCCCCC"> what's</font><font color="#E5E5E5"> encouraging</font><font color="#CCCCCC"> is the</font> trials<font color="#CCCCCC"> that they are doing</font><font color="#E5E5E5"> with the</font> Glasgow and<font color="#E5E5E5"> Caledonian</font><font color="#CCCCCC"> vicious</font><font color="#E5E5E5"> sciences</font>

unit is measuring I've got them here <font color="#CCCCCC">know OSB IVAs</font><font color="#E5E5E5"> non-invasive tear</font><font color="#CCCCCC"> breakup</font> time if a spirometry<font color="#E5E5E5"> in Syriana tree</font> osmolarity corneal and conjunctival staining<font color="#E5E5E5"> and it says it's powered on and</font> knit<font color="#E5E5E5"> but the the Taebaek uptime</font><font color="#CCCCCC"> so that</font>

does sound like<font color="#E5E5E5"> it would meet and</font> assuming the results are what we hope <font color="#CCCCCC">yes</font><font color="#E5E5E5"> i'm jobs repository</font><font color="#CCCCCC"> knows</font><font color="#E5E5E5"> in those</font> spheres it would probably qualify<font color="#CCCCCC"> okay</font> <font color="#E5E5E5">again compared to a control yes I don't</font> <font color="#E5E5E5">know one what control their user user</font>

<font color="#E5E5E5">tells</font><font color="#CCCCCC"> re-register I think they aren't</font> <font color="#E5E5E5">and it's</font><font color="#CCCCCC"> like</font><font color="#E5E5E5"> in here that I think</font><font color="#CCCCCC"> they</font> <font color="#E5E5E5">are using</font><font color="#CCCCCC"> one of the OTC tears and but</font> it's not<font color="#E5E5E5"> actually in my crib sheet at</font> <font color="#E5E5E5">the moment but and I'm pretty sure it's</font> against<font color="#CCCCCC"> the comparator well that that</font><font color="#E5E5E5"> is</font>

not<font color="#E5E5E5"> be</font><font color="#CCCCCC"> enough</font><font color="#E5E5E5"> that would be a necessity</font> for<font color="#E5E5E5"> the FDA okay so assuming from what</font> <font color="#E5E5E5">just said about the</font><font color="#CCCCCC"> endpoints that</font> <font color="#CCCCCC">they're</font><font color="#E5E5E5"> they look at all the</font> measurements are taking assuming it showed efficacy at all those parameters

<font color="#CCCCCC">where</font><font color="#E5E5E5"> in the treatment cascade would you</font> envisage using this it would<font color="#E5E5E5"> be right at</font> the<font color="#CCCCCC"> end of artificial tears it would be</font> the<font color="#E5E5E5"> high end artificial tear and again</font> if it were<font color="#E5E5E5"> depending upon the pricing</font> point<font color="#E5E5E5"> it could</font><font color="#CCCCCC"> be very early in the</font>

scared of treatment what sort of pricing <font color="#E5E5E5">do you think would would</font><font color="#CCCCCC"> be necessary to</font> to have it as<font color="#CCCCCC"> to used generally</font><font color="#E5E5E5"> after</font> <font color="#E5E5E5">the artificial tears I don't say no</font> <font color="#CCCCCC">because</font><font color="#E5E5E5"> of the technology involved it</font> actually had does have quite high cost

of goods so it's not going<font color="#E5E5E5"> to be just a</font> dollar more than<font color="#E5E5E5"> artificial tears yeah</font> that that<font color="#E5E5E5"> would be hard</font><font color="#CCCCCC"> for me</font><font color="#E5E5E5"> to answer</font> because you<font color="#CCCCCC"> know the art the the range</font> of artificial care costs is pretty broad <font color="#E5E5E5">the</font><font color="#CCCCCC"> high-end artificial tears you're</font>

usually talking about<font color="#E5E5E5"> twenty to</font> <font color="#CCCCCC">twenty-five dollars a month</font><font color="#E5E5E5"> okay so</font> looking way to the future and<font color="#E5E5E5"> then think</font> <font color="#E5E5E5">off the</font><font color="#CCCCCC"> top of my</font><font color="#E5E5E5"> head here</font><font color="#CCCCCC"> if if it</font> turned out that<font color="#E5E5E5"> by giving patients and</font> <font color="#E5E5E5">Lana lies it actually reduced the number</font>

<font color="#E5E5E5">of patients</font><font color="#CCCCCC"> that went on to nidra safety</font> <font color="#CCCCCC">so Sidra and would you see that is</font> justifying<font color="#E5E5E5"> being able to</font><font color="#CCCCCC"> own the</font> <font color="#E5E5E5">criteria that could be used for</font> reimbursement<font color="#E5E5E5"> or what sort of price do</font> you<font color="#CCCCCC"> think that could justify</font><font color="#E5E5E5"> hit could</font>

prevent the use of<font color="#CCCCCC"> zero basis</font><font color="#E5E5E5"> it would</font> it be I would<font color="#E5E5E5"> I you know that there</font> <font color="#E5E5E5">would</font><font color="#CCCCCC"> have to be a study to demonstrate</font> that it reduced the<font color="#E5E5E5"> need for Zeigler or</font> <font color="#CCCCCC">worse thesis it couldn't be just a claim</font> that this<font color="#CCCCCC"> is better</font><font color="#E5E5E5"> than any artificial</font>

<font color="#E5E5E5">tear it would have to say this is a</font> benefit that<font color="#E5E5E5"> reduces or precludes the</font> need for<font color="#CCCCCC"> zai drew or rest</font><font color="#E5E5E5"> ASIS yeah</font> <font color="#E5E5E5">because the argument as I see it would</font> <font color="#CCCCCC">be this</font><font color="#E5E5E5"> is</font><font color="#CCCCCC"> a great</font><font color="#E5E5E5"> enhanced artificial</font> tear but<font color="#E5E5E5"> it's still an artificial tear</font>

lubricant<font color="#E5E5E5"> and it would be reimbursed</font><font color="#CCCCCC"> as</font> an artificial tear high-end artificial tear lubricant<font color="#CCCCCC"> you but if it could</font><font color="#E5E5E5"> be</font> demonstrated that<font color="#CCCCCC"> in</font> indeed it did reduce the need for progression<font color="#E5E5E5"> to</font><font color="#CCCCCC"> wrist a scissors I drew</font>

<font color="#E5E5E5">that could then be a claim that</font> insurance companies<font color="#E5E5E5"> and third-party</font> <font color="#E5E5E5">payers would potentially embrace at a</font> lower<font color="#CCCCCC"> cost than</font><font color="#E5E5E5"> wrist</font><font color="#CCCCCC"> ASIS ins I drew</font> English as I said<font color="#E5E5E5"> is</font><font color="#CCCCCC"> about seven to</font> eight<font color="#CCCCCC"> hundred dollars a month okay</font><font color="#E5E5E5"> and</font>

<font color="#E5E5E5">the quick question sure grens</font><font color="#CCCCCC"> is there</font> any<font color="#E5E5E5"> difference in the way they are</font> treated<font color="#CCCCCC"> or are they just treated</font><font color="#E5E5E5"> as the</font> <font color="#E5E5E5">same as any other patient presenting</font> with severe dry<font color="#E5E5E5"> I know generally it's</font> recognized that<font color="#CCCCCC"> Sjogren's because it is</font>

an immune mediated<font color="#E5E5E5"> systemic disease ends</font> up being treated<font color="#E5E5E5"> more aggressively that</font> is the move to<font color="#CCCCCC"> wrist ASIS or</font><font color="#E5E5E5"> zadra is</font> faster the use of intercurrent <font color="#CCCCCC">corticosteroid topical</font><font color="#E5E5E5"> eyedrops</font><font color="#CCCCCC"> is more</font> frequent<font color="#E5E5E5"> and the consideration of other</font>

agents<font color="#CCCCCC"> that aren't necessarily approved</font> for dry eye<font color="#E5E5E5"> such as the the secreted</font> dogs like pilocarpine<font color="#CCCCCC"> and Eva's actors</font> <font color="#CCCCCC">have a melon occurs so the other thing</font> <font color="#E5E5E5">is a lot of practitioners will not delay</font> as long if the responses is not adequate

to<font color="#CCCCCC"> the wrist ASA since I grow to move to</font> autologous serum what's that filamentary keratitis<font color="#CCCCCC"> is that patient group you see</font> a lot of yeah it's usually<font color="#E5E5E5"> seen in</font><font color="#CCCCCC"> the</font> conjunction with dry<font color="#E5E5E5"> eye severe dry eye</font> <font color="#E5E5E5">although it also can be seen with some</font>

allergic<font color="#E5E5E5"> conditions</font><font color="#CCCCCC"> but the the</font> general treatment<font color="#E5E5E5"> for filamentary</font><font color="#CCCCCC"> Kara</font> <font color="#CCCCCC">prophesies is a tends to</font><font color="#E5E5E5"> be more</font> directed at contact lenses<font color="#E5E5E5"> or I don't</font> want to say exfoliated medicines but things<font color="#CCCCCC"> that interfere</font><font color="#E5E5E5"> with the adhesion</font>

of<font color="#E5E5E5"> mucus to the surface and so I think</font><font color="#CCCCCC"> I</font> <font color="#E5E5E5">mentioned in the profile that we are</font> going<font color="#E5E5E5"> to be doing one lamellas is</font> planning some trials<font color="#E5E5E5"> in elementary</font> keratitis last year so next<font color="#E5E5E5"> year because</font> <font color="#E5E5E5">one of the mechanisms of action or one</font>

of the effects<font color="#CCCCCC"> we found with lamellas</font> <font color="#CCCCCC">ohm's</font><font color="#E5E5E5"> was in a different indication</font> which is the dry mouth<font color="#E5E5E5"> and actually on</font> their website if<font color="#CCCCCC"> you have time to</font><font color="#E5E5E5"> just</font> have a look at the dry mouth there's actually a video<font color="#E5E5E5"> of the lamellas</font><font color="#CCCCCC"> ohm's</font>

meeting<font color="#E5E5E5"> and</font><font color="#CCCCCC"> usin globule and they it</font> <font color="#CCCCCC">just explodes into</font><font color="#E5E5E5"> it and makes it runny</font> <font color="#E5E5E5">so they also learn and radiotherapy</font> <font color="#E5E5E5">induce and dose tomia so there is the</font> possibility that the<font color="#CCCCCC"> lamella zone that</font> <font color="#E5E5E5">lamellae eye drops could actually reduce</font>

<font color="#E5E5E5">the viscosity in certain diseases where</font> <font color="#E5E5E5">new sins become more more viscous is</font> that something that<font color="#E5E5E5"> you</font><font color="#CCCCCC"> would see</font><font color="#E5E5E5"> is a</font> major benefit well that would be<font color="#E5E5E5"> a</font> benefit yeah because the<font color="#E5E5E5"> the approaches</font> <font color="#E5E5E5">to trying to interfere with filament</font>

formation really<font color="#E5E5E5"> aren't terribly</font> effective so if it indeed has<font color="#CCCCCC"> a way</font><font color="#E5E5E5"> to</font> interfere<font color="#CCCCCC"> with the</font><font color="#E5E5E5"> mucus accumulation</font> then that<font color="#E5E5E5"> that certainly</font><font color="#CCCCCC"> could</font><font color="#E5E5E5"> be a</font> benefit<font color="#E5E5E5"> okay</font><font color="#CCCCCC"> because I mean have you</font><font color="#E5E5E5"> got</font> any other comments on the target product

profile and problem what we've already discussed<font color="#E5E5E5"> I mean</font><font color="#CCCCCC"> can I just</font><font color="#E5E5E5"> reiterate</font> the reimbursement<font color="#E5E5E5"> if we</font><font color="#CCCCCC"> had the</font><font color="#E5E5E5"> clinical</font> <font color="#E5E5E5">data to</font><font color="#CCCCCC"> back up</font><font color="#E5E5E5"> the claims and assuming</font> on the other hand the office of combination products accepts it as a

device<font color="#E5E5E5"> rather than</font> an NDA the reimbursement provides how would that play<font color="#CCCCCC"> out do you think if it</font> <font color="#CCCCCC">was</font><font color="#E5E5E5"> going to be it's going to</font><font color="#CCCCCC"> be you</font> <font color="#E5E5E5">know just what we've talked about the</font> there would have to be demonstrable

benefit<font color="#E5E5E5"> to limit the need to move to</font> some of the more expensive medications<font color="#CCCCCC"> I</font> think that would be<font color="#E5E5E5"> the</font><font color="#CCCCCC"> the space</font><font color="#E5E5E5"> that I</font> would I would think<font color="#CCCCCC"> lamelle I might make</font> a an inroad<font color="#E5E5E5"> I don't think competing</font><font color="#CCCCCC"> with</font> other<font color="#E5E5E5"> artificial tears alone would lead</font>

<font color="#CCCCCC">to its approval for reimbursement</font> because<font color="#E5E5E5"> my experience with the</font><font color="#CCCCCC"> insurance</font> companies is<font color="#CCCCCC"> that unless you can</font> <font color="#CCCCCC">demonstrate a significant benefit above</font> the level of lubrication<font color="#E5E5E5"> then they're</font> not likely to consider it for

<font color="#E5E5E5">reimbursement that they consider it a</font> very fine artificial tear yeah there isn't an automatic as far as you know there<font color="#CCCCCC"> isn't an automatic</font> disqualification for reimbursement based on device classification<font color="#E5E5E5"> no I don't</font>

think<font color="#E5E5E5"> so but the the hurdles for getting</font> the payers to<font color="#E5E5E5"> agree to to cover it is</font> significant<font color="#CCCCCC"> I've</font><font color="#E5E5E5"> seen at</font><font color="#CCCCCC"> least two or</font> three companies<font color="#E5E5E5"> struggle to try to get</font> devices approved<font color="#E5E5E5"> but again if they can</font> demonstrate a significant statistical

benefit above a standard therapy then then then they have an argument<font color="#E5E5E5"> that's</font> likely<font color="#CCCCCC"> to be heard yeah okay</font> and<font color="#CCCCCC"> think that's it</font><font color="#E5E5E5"> for my questions</font> <font color="#E5E5E5">unless you've got any other comments on</font> the target product profile<font color="#CCCCCC"> oh</font><font color="#E5E5E5"> actually I</font>

do<font color="#CCCCCC"> have another one for</font><font color="#E5E5E5"> you I just</font> <font color="#CCCCCC">realized in terms of the</font><font color="#E5E5E5"> stability I</font> mean<font color="#E5E5E5"> lamella are looking at different</font> potential presentations<font color="#E5E5E5"> and formulations</font> <font color="#E5E5E5">but at the</font><font color="#CCCCCC"> moment with the current</font> formulation<font color="#E5E5E5"> it</font>

I mean<font color="#E5E5E5"> distribution in sales would have</font> to be cold chain and then once it's dispensed<font color="#CCCCCC"> to the patients it</font><font color="#E5E5E5"> become be</font> room temperature<font color="#CCCCCC"> for up to six months or</font> one month<font color="#E5E5E5"> once opened would you see</font><font color="#CCCCCC"> that</font> in from an<font color="#CCCCCC"> ophthalmologist</font><font color="#E5E5E5"> or specialist</font>

point of view would you see<font color="#CCCCCC"> that as a</font> <font color="#CCCCCC">major problem not a</font><font color="#E5E5E5"> major problem but</font> certainly a problem<font color="#E5E5E5"> if again here it</font> depends upon efficacy<font color="#E5E5E5"> if it is very</font> efficacious<font color="#E5E5E5"> those features about cold</font> <font color="#E5E5E5">transport and limited duration don't</font>

become as much<font color="#CCCCCC"> of a</font><font color="#E5E5E5"> hindrance but if</font> it's like a high-grade artificial tear that would be a deterrent yeah<font color="#CCCCCC"> that it</font> had to<font color="#E5E5E5"> be cold stored and and then</font> released for a short<font color="#CCCCCC"> period of time</font><font color="#E5E5E5"> okay</font> <font color="#CCCCCC">and</font><font color="#E5E5E5"> I think</font><font color="#CCCCCC"> I just want my very</font><font color="#E5E5E5"> last</font>

<font color="#CCCCCC">question that isn't actually on my sheep</font> and<font color="#CCCCCC"> when I</font><font color="#E5E5E5"> skip anyway you mentioned in</font> severe patients that have failed<font color="#E5E5E5"> the</font> approved therapies<font color="#E5E5E5"> there are a number</font><font color="#CCCCCC"> of</font> off-label uses<font color="#E5E5E5"> drugs that you use can I</font> ask<font color="#E5E5E5"> I know in Japan</font><font color="#CCCCCC"> there's a tech</font>

columnist<font color="#E5E5E5"> I dropped is that something</font> that's used<font color="#E5E5E5"> off-label in in the</font><font color="#CCCCCC"> u.s. oh</font> <font color="#CCCCCC">I'm sorry I didn't</font><font color="#E5E5E5"> hear that again so</font> what's the name of<font color="#CCCCCC"> the drug</font><font color="#E5E5E5"> attacker</font> <font color="#E5E5E5">Lima sort economist however you</font> pronounce it<font color="#E5E5E5"> oh yeah</font><font color="#CCCCCC"> tactically</font><font color="#E5E5E5"> miss yes</font>

<font color="#CCCCCC">economic yeah</font><font color="#E5E5E5"> it yeah it is in the same</font> <font color="#E5E5E5">category</font><font color="#CCCCCC"> as rest' ASIS</font><font color="#E5E5E5"> any</font> something that there's no approved product<font color="#CCCCCC"> event in the US but is that</font> <font color="#E5E5E5">something that's used compounding</font> pharmacies or<font color="#E5E5E5"> is that something that yes</font>

you<font color="#E5E5E5"> know</font><font color="#CCCCCC"> and some some practitioners</font> will will use tacrolimus<font color="#E5E5E5"> but it's not</font> <font color="#CCCCCC">widespread use thank you okay</font><font color="#E5E5E5"> well I</font> think I've come to<font color="#CCCCCC"> the end of</font><font color="#E5E5E5"> all my</font> <font color="#CCCCCC">questions but</font><font color="#E5E5E5"> that's been extremely</font> <font color="#E5E5E5">useful</font><font color="#CCCCCC"> and if we come up with</font><font color="#E5E5E5"> anything</font>

else<font color="#CCCCCC"> just after the call is it</font><font color="#E5E5E5"> okay just</font> <font color="#CCCCCC">to</font><font color="#E5E5E5"> drop you a quick line I don't think</font> <font color="#CCCCCC">sex I've actually covered everything</font> <font color="#CCCCCC">that I've got</font><font color="#E5E5E5"> on my list yep</font><font color="#CCCCCC"> happy to</font> respond to<font color="#E5E5E5"> email as you need</font><font color="#CCCCCC"> to drop it</font> my way okay<font color="#CCCCCC"> brilliant in which case the</font>

last Grand Gallery<font color="#E5E5E5"> good and I did</font> mention<font color="#E5E5E5"> and an email that we're happy to</font> give a not on an area<font color="#E5E5E5"> and if that's</font> something<font color="#CCCCCC"> that you normally get for</font><font color="#E5E5E5"> your</font> time and if<font color="#E5E5E5"> that's</font><font color="#CCCCCC"> something that you</font> would like<font color="#CCCCCC"> do could you</font><font color="#E5E5E5"> just drop me</font><font color="#CCCCCC"> a</font>

line with some details<font color="#CCCCCC"> okay I will do</font> <font color="#E5E5E5">that okay in which case thank you very</font> much for<font color="#E5E5E5"> your time and</font><font color="#CCCCCC"> bit over half an</font> <font color="#E5E5E5">hour but that's been really useful so</font> thanks again<font color="#CCCCCC"> have a good</font><font color="#E5E5E5"> rest of the</font> afternoon

<font color="#E5E5E5">all</font><font color="#CCCCCC"> righty</font><font color="#E5E5E5"> thank you</font><font color="#CCCCCC"> very thank</font><font color="#E5E5E5"> you</font><font color="#CCCCCC"> bye</font> <font color="#E5E5E5">bye</font> keep more<font color="#CCCCCC"> pharma</font><font color="#E5E5E5"> venture</font>



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