Bascom Palmer’s 19th annual Angiogenesis, Exudation, and Degeneration Meeting 2022 is a virtual event scheduled for February 11 and 12, 2022. The program is focused on understanding and treating neovascular and exudative diseases of the eye with the emphasis on the revolutionary pharmacologic therapies that are being developed and the clinical management of neovascular age-related macular degeneration (AMD), macular edema, diabetic retinopathy, and retinopathy of prematurity. Another special focus is the current and future impact of the developing pharmacotherapies on clinical practice and Medicare, according to the program coordinators.

Professor of Ophthalmology and The J. Donald M. Gass Distinguished Chair in Ophthalmology; and 

Professor of Clinical Ophthalmology — all from the Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami.

The scheduled program is outstanding, with a slate of distinguished national and international basic scientists, clinicians, and healthcare experts who will share the latest developments in imaging, translational research, and clinical trials as well as the impact these advances will have on clinical ophthalmology.

Retina specialists expressed enthusiasm about the promise of the information that will be disseminated at the meeting.

According to Anat Loewenstein, MD, chair, Department of Ophthalmology, Tel Aviv Medical Center, Tel Aviv, Israel, and a program panelist, “The angiogenesis meeting is a unique conference in size and scope. First, I think that it includes all the state-of-the-art current treatments of most retinal diseases. At the same time, new modalities of treatment and monitoring are being presented, which allows the audience to not only learn about the current treatments but also gain information about the newly approved ones and the ones that are still under assessment.”

She continued, “It is a big meeting but not too big to prevent fruitful discussion for which there is usually enough time allocated, making that another special feature of this meeting."

Dr. Albini, commented, “There is simply no better event, streaming or in-person, to get an update and overview on the amazing novel therapeutics in exudative and degenerative retinal disease.”

This year’s activities begin on Friday, February 11 at 7:50 Eastern time with an opening address by the co-directors.

The following 5 sessions are scheduled for day 1 beginning at 8 am and adjourning at 1:20 pm.

Session I: Genetics, Histopathology, and Imaging in Non-Exudative AMD

Session II: Predicting Progression of AMD

Session III: Emerging Therapies for Non-Exudative AMD

Session IV: C3 Inhibition for the Treatment of Geographic Atrophy; 

session IV also will include a panel discussion titled “Clinical trial endpoints for non-exudative AMD” at the conclusion of the session.

Session V: OCT Imaging and Risk Factors for Exudative AMD

The day 2 program, which also will feature 5 sessions, will begin on Saturday, February 12 at 7:50 am with opening comments and run until 2:30 pm.

Session VI: Emerging and Current Therapies for Exudative AMD; the session will include a discussion of the Ranibizumab Port Delivery System presentations.

Session VII: Dual Inhibition of Ang2 and VEGF for the Treatment of Exudative AMD and DME–An Update from the Faricimab Program; a discussion session will follow.

Session VIII: Diabetic Retinopathy-Imaging and Staging

Session IX: Diabetic Retinopathy-Treatment

Session X: Retinal and Choroidal Vasculopathies and Degenerations

More detailed information about the specifics of each sessions and the speakers can be obtained on the 

 and interested clinicians are invited to sign up.

Articles

Angiogenesis

The meeting places a special emphasis on pharmacotherapies in the pipeline for the treatment of neovascular exudative diseases of the eye and how they will affect clinical practice and Medicare.

Program for Angiogenesis 2022 ignites excitement in ophthalmologists

Firas Rahhal, MD, discusses the results of Outlook Therapeutics’ pivotal NORSE TWO trial for ONS-5010. The Phase 3 results show efficacy for the ophthalmic solution of bevacizumab for the treatment of wet macular degeneration.

So what we presented today was a new ophthalmic preparation for bevacizumab. And the background is that bevacizumab is a drug we use a lot; currently, for wet macular degeneration and other diseases, but we use it in a compounded form. Something that compounding pharmacies prepare off the intravenous version, and that makes it off-label. And so there's certain problems associated with that type of preparation.

And so what we're doing now is developing this ophthalmic solution made specifically for the eye of the same drug, essentially the same drug, for wet macular degeneration. And we presented the so-called Phase 3 data today of our trial showing efficacy.

So this would be the pivotal study, so there wouldn't have to be a lot of further data collection. What we showed today, just to review, is that 41.7%, or almost 42% of patients receiving this product gained 15 letters, which means three lines of vision gain, which is very good, and historically comparable to our standards with other name-brand drugs.

It also achieved a really high number of lesser gainers—which is also important and often not talked about as much—five and 10 letters or one- and two-line vision gainers was a very high number approaching 70%. That also compares very favorably with our expectation for this treatment class.

But as far as collecting more data, little to none would be needed now for wet AMD. Actually, the next frontier will be at some point for the company to—maybe next year, I think first quarter—apply for FDA approval, but then to consider testing it in other disease processes like diabetic retinopathy, that we use the off-label Avastin for now.

 Interview occurred in November 2021, referencing the first quarter of next year for BLA filing as first quarter 2022.

Videos

Firas Rahhal, MD, discusses Outlook Therapeutics’ Phase 3 pivotal NORSE TWO trial for ONS-5010.

Ophthalmic bevacizumab effectively treats wet macular degeneration, NORSE TWO concludes

At the 2021 American Academy of Ophthalmology annual meeting, Ted Leng, MD, presented his talk entitled “Variations in Vitreoretinal Physician Utilization of Ancillary Testing: An IRIS Registry Analysis” during Retina Specialty Day. The IRIS Registry Analysis considered how many ancillary tests were ordered on a per patient basis, accounting for a variety of factors to identify patterns.

 This is a really exciting study that we conducted using the American Academy of Ophthalmology’s IRIS registry, given just a large amount of data that's in there. And as a retinal physician, we are super reliant on ancillary testing in our everyday practices to see, you know, which patients have retinal disease and how we're managing them.

So what we wanted to do in this study was to look at the utilization of ancillary tests by retinal physicians in the United States on retinal patients.

To go into some more detail, this was a three-year study, where we looked at retinal physicians from January 2018 to December 2020. And look at the amount of OCTs, fundus photographs and fluorescein angiograms they were performing. And then we normalized that data and looked at how physicians in different regions throughout the United States were using these tests, whether certain payers like Medicare or non-Medicare were utilizing these tests, and then also different practice settings, such as academic medical centers versus nonacademic medical centers.

What we found was actually quite interesting. Once we did normalize the data, we did see that physicians in the Midwest region—and we use the four regions of the US Census Bureau—so the Midwestern states actually were performing more OCTs on a per patient basis than physicians in other regions. Medicare patients were getting more OCTS on a per patient basis per year than non-Medicare patients. And lastly, patients cared for in a nonacademic medical center, were getting more OCTs on a per patient basis than that not.

So I think, while those results in and of themselves are interesting, we then delve deeper into trying to ask why we saw these differences in practice patterns amongst retinal physicians. And one of the things that we looked into was the volume of wet macular degeneration patients as a kind of benchmark to see if that affected the use of OCT-A, for example.

So what we did was we asked, does a physician who sees more wet AMD patients per year use more OCT or less OCT than someone who doesn't do as many wet macular degeneration patients.

And what we did find was that retinal doctors who saw more wet AMD patients also ordered more OCTs in general.

And what we did with that information, is we went back and did a reanalysis of the data, our findings, and saw that yes, indeed, Midwestern physicians also see more wet AMD patients than non-Midwestern physicians. And that could help to explain why more OCTs are being performed in the Midwest on a per patient basis.

And similarly, in the Medicare population, there are more new wet AMD patients. And in the nonacademic medical center setting, there are more wet AMD patients that are new. So that's why it could help to explain why we are performing as a specialty more OCTs and other ancillary tests in those regions. And in those pair types in this practice settings.

What are the implications for the larger community? I just think it's really good to know, you know, how we're practicing medicine, what the patterns of utilization of our ancillary testing is, so that we can then better inform how to make our practices more efficient, how to better deliver care to the patients, and maybe even identify underserved populations.

You know, one thing we did see was that in the Medicaid population, there was less OCT-A utilization. And so we do need to delve deeper into maybe an explanation as to why that is, but they could be an indication that that populations being under cared for and underserved. And maybe, you know, we need to be ordering more tests to, to better manage those patients. So I think that's one of the potential takeaways from this presentation.

The American Academy of Ophthalmology (AAO) annual meeting was held November 12 to 15 at the Ernest N. Morial Convention Center in New Orleans, Louisiana. The event included Subspecialty Days and a virtual component for remote participation.

Ted Leng, MD, discusses his presentation, “Variations in Vitreoretinal Physician Utilization of Ancillary Testing: An IRIS Registry Analysis” during Retina Specialty Day at AAO 2021.

Using the IRIS registry to analyze ancillary testing patterns on a per patient basis

 Absolutely. That's what's always been so fascinating about ophthalmology, is just the innovation and just looking at something a different way, taking an application that's been used elsewhere and giving a different spin or a different twist on it, using it in a different way. That's something that's always been very fascinating and interesting. Yeah. I guess another thing is just when you go to the academy and you come back, you feel so ... One, you're exhausted, right? But you're also re-energized, reinvigorated. You have so many different ideas and talking to colleagues and listening to all these different talks and presentations. You come back with just so many ideas charging through your head. That's something that I always find, so I just wonder how it is for ophthalmologists as well.

Well, that's true. We're very fortunate in ophthalmology, we're such a competitive field. This year, for my department for our 5 residency slots, we have 630 applications and they're all the brightest, smartest kids in their medical schools. It's amazing. And I think those of us who are ophthalmologists really enjoy our very intelligent and fun colleagues that we train with and work with and we all get together at least once a year hopefully, at the academy, to catch up and learn from each other. Exactly, as you said, there is the formal, I guess you'd say, didactic learning that occurs in the formal sessions and the poster sessions. But then there's the informal experiences we get from being able to talk about our ideas or what we're doing in our practices with our colleagues and see what they're doing in their practices that's working well.

One of the fun things I'll just mention, talking about inspiring this year, was a session the academy had on with its current president, Tamara Fountain, MD, and 4 other previous women presidents of the American Academy of Ophthalmology (AAO), and I think the increased prominence of women leaders at the academy has been a hallmark of the leadership of our CEO, David Parke II, MD, during his tenure at the ACademy and our current president, Fountain, is a graduate of my department so we, of course, know how brilliant she is but there's such a overall, such an impressive group of people and such an impressive group of leaders.

Forget women leaders, just leaders in general—they're just a great impressive group of people and I actually have had young people, women residents and medical students, who attended that session, tell me how inspiring it was to them to be able to hear from this group of women leaders of the Academy, and I think that really bodes well for our specialty. Our training programs now are about 50/50 male/female and I think seeing these great role models of women running the Academy is really a thing that's really going to inspire this young generation of ophthalmologists who become our future leaders.

 That’s great. And I guess the other thing about this meeting is, obviously, it's at the end of the year but you're heading into the next year. So as we head into 2022, it really sets the stage for just a lot of different innovations and new ... paving the way forward through ophthalmology as we head into the year and begin anew. It's always a refreshing change or fresh start.

 Yeah, that's for sure and my friends who track the venture capital world tell me that ophthalmology right now is one of the most popular areas in which venture capital people are investing their dollars because of what they see as the potential to develop a lot of exciting breakthrough new therapies. It looks like the future is going to be even brighter in terms of innovation and excitement. So those of us who are closer to the ends of our careers in ophthalmology rather than to the beginnings of our careers are probably jealous of the exciting future that our young trainees are going to have with all this great interest in supporting our research and development in the eye care industry. And so, yeah, I think you're absolutely right, this next year when we're all together in Chicago, it's going to probably be more exciting and it will just continue year after year.

Stevenson: Yeah, I was just going to say that next year, it's in Chicago and (I’m) hoping the pandemic will be in a different place next year by this time, and we can have it all in-person for gatherings, so that'll be really awesome.

McDonnell: You're right, it'll be great. Chicago's, historically, been a great venue for Academy meetings. It's more a steak restaurant than the Cajun food of New Orleans, but also excellent lot of great choices for where to dine after the educational sessions and it's a fun city to tour. If you've never taken the architectural boat tour in Chicago, you have to do that. Already looking forward to next year and to the next Academy meeting in Chicago.

Stevenson: Well, thank you so much. It's been great to kind of visit with you again and talk about the recap of this year'sAmerican Academy of Ophthalmology in New Orleans ,and definitely look forward to seeing everybody again in Chicago next year.

 Absolutely, and I know all your listeners are all going to be studying their upcoming issues about 

® to read in more detail about lots of the exciting presentations and new technologies that were presented this year.

Dr. McDonnell highlights inspiring moments from the 2021 annual meeting of the American Academy of Ophthalmology, along with a look ahead to next year’s conference in Chicago.

AAO 2021 reinvigorates ophthalmologists for 2022

Well, Dr. McDonald, so great to see you again. I hope you've recovered from the Academy meeting this year in New Orleans,

Peter J. McDonald, OD, FAAO: Ms. Stevenson's … always a pleasure to see you. I heard people saw you with the marching band around the convention hall, but I didn't see you do that. But I heard you were really enjoying New Orleans.

: Well, it's great to be back. I just want to take a few minutes and check in with you and see what your impressions were. What the takeaways were that you brought back from this meeting?

 Well, my view: the American Academy of Ophthalmology is a great organization. It should be the model for all the other medical specialties with their professional organizations. They always do a great job with this meeting. They put on the biggest meeting of ophthalmologists in the world. The meetings cover everything.

You learn a lot about whatever is exciting and interesting to you based on your practice. Pandemic or not, the Academy did its usual great job this year to help educate our fellow ophthalmologists. There were medical students there and residents, and everybody by all reports had a great time. My congratulations to the Academy leadership for doing such a good job again this year.

 Absolutely. I know they had a lot of safety precautions in place. You had to be vaccinated to attend the in-person component of it. There was also a virtual component. Masks were required during the actual time they were in the convention center.

A lot of precautions were taken but I feel everybody had a really good time. A lot of good content was presented. Even starting from subspecialty day, I should say that, a lot of the different topics that were focused there and continuing into the main actual conference.

 Yeah. The subspecialty days are so super popular. They have been for decades, and under [CEO] David Parkes’ leadership at the Academy, they've just been growing and growing in interest in popularity. One of the fun features of the subspecialty days is that they reserve parts of the schedule for the breaking exciting news. Not things that were submitted 6 months ago to the Academy, but things that maybe article presentations about what's happened just within the last few weeks.

Despite the pandemic, there's been a lot of innovation this year in ophthalmology and recent FDA approvals of new drugs and new technologies for treating eye disease. There was a lot of good information at the Academy about some of these new products, and that engendered a lot of interest, whether it's front of the eye dry eye or back of the eye for retinal disease.

 Absolutely. I guess in talking to some of your fellow colleagues, what are some of the highlights that you've been hearing from fellow ophthalmologists from this year's meeting?

Well, I was smart enough to become a retina specialist. I'm a cornea person but my retina colleagues tell me there's tremendous interest in the just recently approved port delivery system (PDS) for delivering ranibizumab (Lucentis, Genentech).

During this pandemic, having these people come in every month or 8 weeks to get an intravitreal injection is quite a challenge— both on the patients and the doctors and the clinics. The newly FDA-approved delivery system allows the opportunity to dramatically reduce the number of visits and the frequency of injections for these patients.

I believe the launch of this device is going to be pretty soon and there was tremendous interest in learning about it. I think tremendous eagerness amongst our retina brothers and sisters to be able to begin to look at incorporating this into their practices and to see for which patients it works well and how well it's accepted amongst the patients with (age-related macular degeneration) AMD.

The new, recently approved super choroidal administration of triamcinolone (Bausch + Lomb, Clearside Biomedical) using these micro needles Xipere, is that name apparently of this which will again be launched in the new year. This is an interesting—also new—technology for retinal disease as for macular edema in the setting of uveitis. But instead of intravitreal injections, these are through the sclera into the super choral space.

This is a whole new thing for us ophthalmologists. There is a lot of going to be learning on how to do this. It'll be again interesting to see how this gets adopted. The approval is for macular edema in uveitis patients, but obviously there is the potential for triamcinolone to be helpful for other indications. I think this was an exciting topic in New Orleans. One that will be a very exciting topic coming into the new year in our meetings in 2022.

Then I'm a cornea external disease dry eye person. The newly approved this company called Oyster Point (Pharmaceuticals) and its nasal spray—this is worth learning about. This is the drug that's used to help reduce the craving for smoking and administered intra-nasally.

It improves dry eye in the FDA trials. This will be interesting because it's such a new route of administration, treating an eye problem with a nasal spray. It'll be interesting to see when this launches in the first quarter of next year, how this new way of administering medication for eye disease, [and] how readily it's accepted by both doctors and our dry eye patients.

Some very interesting new technologies. In each case, it's not so much a new drug. They're preexisting drugs but new ways of delivering the drug. Triamcinolone has been around forever. Ranibizumab for a long time. As I mentioned with the nasal spray, the active agent has been available for quite a while now for smoking cessation. It's about new routes of administration for new ophthalmic indication. It's exciting to see all these innovation despite the pandemic.

Peter J. McDonnell, MD, shares some of many highlights from this year’s annual meeting of the American Academy of Ophthalmology in New Orleans.

Reflecting on key takeaways from AAO 2021 with Peter J. McDonnell, MD

Jill Hopkins, MD, Senior Vice President and Global Development Unit Head, Ophthalmology, Novartis Pharmaceuticals, sits down with David Hutton of 

 to discuss the recent results of the Phase 3a results of the Merlin trial.

Brolucizumab (Beovu, Novartis Pharmaceuticals) is being investigated for the treatment of both wet age-related macular degeneration (AMD) in the MERLIN trial and diabetic macular edema (DME) in the KESTREL and KITE trials.

. We are joined today by Jill Hopkins, Senior Vice President and Global Development Unit Head, Ophthalmology, Novartis Pharmaceuticals, who will provide an update on data the company presented at the American Academy of Ophthalmology is 2021 annual meeting. Thanks for joining us today.

Thanks, David. It's a pleasure to be here. Happy to share with you some of the noteworthy data that we presented at the AAO meeting this past week. We presented on Beovu in both wet AMD and DME, and I'll speak about both of those.

In wet AMD, we presented the results of our Phase 3a Merlin trial, Dr. Khanani presented that. And this was a trial where we looked at the use of Beovu on a monthly basis to treat wet AMD in patients who had persistent disease activity, despite having been treated with prior anti-VEGF. And we were very interested in exploring the capacity, capability, of Beovu to dry the retina and maintain vision in patients in that situation.

And so we looked at monthly Beovu compared to monthly aflibercept. And we found some very interesting results. What we saw, similar to what we'd seen in our pivotal trials with AMD, that we did have noninferiority vision and strong evidence of drying. So we actually were able to show superior drying effects in both the reduction in the central subfield thickness on the OCT measurement, and in the proportion of patients who were fluid free at the end of year one.

We did unfortunately, however, see higher rates of inflammation in the Beovu treated eyes—about 9% in Beovu compared to about 4.5% in aflibercept. And for that reason, we are maintaining our currently labeled dosing recommendation, which is the three loading doses followed then by extension to Q8 or Q12 week dosing and not recommending the monthly in Beovu.

So the other piece of work that we have been presenting and have submitted for approval is our use of Beovu in diabetic macular edema.

So again, we've conducted two pivotal trials, and these were reported at AAO as well, KITE and KESTREL, where we looked at the use of Beovu with a loading phase and then extended intervals. And we're pleased to see in diabetic macular edema as well, this sustained drying, fewer injections and maintenance of visual acuity.

So we're excited by this particularly in a condition like diabetes, where we know that patients are often still working, they're trying to manage multiple health issues related to their diabetes. So anything that we might be able to offer retinal physicians and patients that reduces the burden of injection frequency, while still maintaining very good anatomic control and maintaining vision is exciting to us. And we have submitted those for regulatory approval in the US, in Europe and in Japan. So we're hoping for a positive readout of those submissions in the middle of 2022.

Jill Hopkins, MD, discusses results from phase 3a of the Merlin trial for brolucizumab as a treatment for wet AMD and provides updates on KESTREL and KITE trials for the treatment of diabetic macular edema.

Brolucizumab shows evidence of retinal drying in wet AMD

Penny Asbell, MD, FACS, MBA, discussed data from the ARMOR study with the editors of 

 at AAO 2021. The ARMOR study is a 10-year nationwide study examining in vitro antibiotic resistance among isolates that have been collected from ocular infections. The data sheds light on the effects of antibiotic resistance while treating ophthalmic infections, such as endophthalmitis.

The Antibiotic Resistance Monitoring in Ocular Microorganisms (ARMOR) surveillance study has identified high levels of in vitro antibiotic resistance among ocular staphylococcal and pneumococcal pathogens, resistance that may affect treatment success.

Penny Asbell, MD, FACS, MBA, is the director of the Hamilton Eye Institute at the University of Tennessee Health Science Center.

So, you know, ophthalmologists, we really like to get a lot of data. We take pictures, we take images, we take measurements. But with infection, we really got to start treating right away. And one of the questions is, what antibiotic should we start with?

So actually the ARMOR study, which is the only surveillance study done in the United States of ocular isolates, is a real good source of information when you're getting started.

So, we collect ocular isolates from over 44 sites and 22 states over the last 10 years. And in this particular study, we looked at isolates that were collected from either the aqueous, or the vitreous, presumably a patient who had serious infections such as endophthalmitis.

And what was most interesting is that nearly 50% of them were staph isolates that were methicillin resistant, so a high level of resistance to methicillin. But equally interesting is those methicillin resistant isolates, over 70% of them were resistant to three or more other groups of antibiotics. So you got to realize resistance is out there.

Now, this is laboratory testing. It's a standardized method. It's not actually clinical. In clinical, you might do a lot better than laboratory test suggests, but you got to start somewhere. It's a really good way of getting some information right off the bat, even while you're waiting for those cultures.

So think about resistance, it's not uncommon, whether it's staph aureus—we didn't see as much with strep pneumonia, and pseudomonas did pretty well, and so did the H. flu. But that staph still is a problem for us with the methicillin and the multi-drug resistance. So keep that in mind when you're picking an antibiotic.

So, you know, we've collected in the ARMOR study over 6000 isolates, and we're starting to try to understand what are the mechanisms of pathogenicity? What makes an isolate more serious than another isolate? And is it actually the isolate itself, or the interaction between the isolate, the organism, and its genetics and the person who gets infected?

So there's a lot of information there and a lot of opportunities to really understand infection more specifically, and maybe have new interventions for treating more effectively. So, we're gonna use that data to the best we can to give us the best information to be able to treat our patients the best way. So stay tuned for ARMOR data, we keep coming. Thank you for listening.

At the 2021 American Academy of Ophthalmology annual meeting, Penny Asbell, MD, FACS, MBA, discussed data from the ARMOR study and its effects on treating ophthalmic infections, such as endophthalmitis.

ARMOR study: data sheds light on antibiotic resistance in ophthalmology

At AAO, Jay Duker, MD, sat down with the editors of 

™ to discuss EyePoint Pharmaceuticals’ pipeline product EYP-1901. As a sustained-release anti-VEGF, EYP-1901 has the potential to be a durable treatment option for wet AMD, possibly extending time between injections to six months.

EYP-1901 has completed phase 1 clinical trials for treatment of wet AMD. The biannual injection is vorolanib, a tyrosine kinase inhibitor, which is distributed by EyePoint Pharmaceuticals’ proprietary Durasert implant. The implant is bio-erodible and has a history of safety: four products have been FDA-approved for use with Durasert.

I'm going to talk about our new exciting pipeline product, EYP-1901. EYP-1901 is a sustained-release anti-VEGF, which has the potential to be an every six month injection for wet macular degeneration. EYP-1901 is vorolanib, which is a tyrosine kinase inhibitor which has activity against all the VEGF receptors. It is in our proprietary Durasert implant. The Durasert implant and the EYP-1901 is bio-erodible. We've had four FDA-approved products using Durasert, so there's a long history of safety for the product.

Vorolanib was tested previously in both a phase 1 and phase 2 trial in humans for wet macular degeneration as an oral preparation. And while it showed good efficacy signals in those investigations, unfortunately, it was toxic systemically. So by using it locally, we expect to get around the toxicity. And in fact, the phase 1 results which were recently presented at the AAO meeting by David Boyer showed that we had a very impressive safety profile.

In the 17 patients in the phase 1 trial, we had no ocular serious adverse events. We had no drug-related systemic adverse events. The adverse events that were reported were grade two or less in all cases, except one, which was not drug-related. So we feel that the safety profile looked very strong.

We also showed evidence of efficacy. All of these patients who were previously treated and previously treated wet AMD patients get most of their visual acuity improvement in the first three months. Since they all were enrolled four months or longer, we didn't expect any visual acuity improvements, but we hoped for stability. And in fact, that's what we found. With the 17 patients at the end of six months, the only change in visual acuity across the whole cohort was approximately minus two letters.

With respect to OCT, which is a measurement of VEGF activity, again, we expected stability in this previously treated group. And that's we found. At the end of six months, there was a small decrease in the retinal thickness on OCT of a very minimal amount, about two microns.

We also had what we feel is a very impressive rescue free rate, up to the four-month visit. 76% of the eyes did not require a rescue standard of care injection, and up to six months, 53% of eyes did not require a standard of care rescue injection. We also measured what we refer to as treatment burden. How many injections on average per month did the patients get prior to enrollment? And then for the six months, after how many injections standard of care did they require? We had what we feel as a very clinically significant decrease of a burden of the injections by 79% across the entire cohort.

So we're very excited by David Boyer’s presentation and we look forward to taking this product into multiple phase 2 trials in 2022.

Just to add to Dr. Jay Duker’s comments, we’re obviously very pleased with the results of this study. And want to also just comment: for EyePoint Pharmaceuticals, it's really a major milestone forward.

Where we plan to be able to go into Phase 2 studies, as Dr. Duker mentioned, but in addition, we have other molecules that we believe can be used in Durasert to treat retinal eye diseases. And certainly the DAVIO [Durasert and Vorolanib in Ophthalmology] study really helped us cross a key hurdle in terms of proving that we could take these molecules forward and get a safe, and in this case, efficacious outcome in in a small Phase 1 study.

So we're very pleased with this, we've got big plans ahead for the company, and we're quite excited about the future. In addition, I want to add, we're thrilled to be able to potentially advance these treatments for patients as well.

 transcript has been lightly edited for clarity.

Jay Duker, MD, discusses EYP-1901, EyePoint Pharmaceuticals’ sustained-release anti-VEGF drug for the treatment of wet AMD.

New sustained-release anti-VEGF formula proves safe and effective in phase 1 trials

Michelle Senchyna, PhD, spoke with Modern Retina at the American Academy of Ophthalmology 2021 annual meeting about the phase 2b study results of AR-15512 for the treatment of dry eye. The TRPM8 antagonist stimulates the production of tears and creates a cooling sensation across the ocular surface to treat both signs and symptoms of dry eye. Two concentrations were tested in the trial; both formulations were found to be safe and well-tolerated.

 Hello everyone, my name is Michelle Senchyna. I am the vice president of both clinical development and medical affairs at Aerie Pharmaceuticals, and I'm at AAO and pleased to talk to you. We just presented the results from our phase 2b study on our asset AR-15512, which is a TRPM8agonist.

TRPM8 is a neat little receptor. It causes, when stimulated, the production of tears as well as a cooling sensation across the ocular surface. And so because of those mechanisms, we think it will be a fantastic asset to treat the signs and symptoms of dry eye.

In our relatively large phase 2b study, a total of 369 patients that were randomized between two different concentrations of 512 as well as vehicle, we saw very statistically significant increases in tear production with both concentrations of 512. It was actually the high dose, 0.003%, that demonstrated the most robust efficacy, upwards of 20 mm of wetting on an uninitialized Schirmer.

When we looked at the data a different way based on a responder analysis, where a responder is someone that has an increase of at least 10 mm of wetting, between 82–86% of the population in the high dose were responders. It's just a phenomenal response.

Now, symptom-wise was even more exciting. We saw statistically significant improvements with the high dose of 512, first based on a SANDE questionnaire as early as day 14. And then the magnitude of that improvement actually got better at day 28 and 84, relative to vehicle. We also saw statistically significant improvements in ocular discomfort and eye dryness both at day 84.

And then lastly, we showed some really unique data, and that is, signs and symptoms are something that really resonates to the clinician. But at the end of the day, we know quality of life is what matters to patients. And so we saw with again, the high dose of 512, very statistically significant improvements in a number of different measures of quality of life, things like driving or reading or watching TV. And that was just very exciting—again, as early as day 14. So these folks are definitely getting better, and consistent with the sign and symptom improvement.

From a safety perspective, all formulations were safe and well-tolerated. The number of ocular adverse events that we had was normal, and 95% of those were reported as mild by the subjects.

So in sum, we are just really very excited about the data. We showed multiple sign and symptom improvements quality of life improvements. We have selected the high dose of 512 to go into phase 3 development. We are going to be starting those studies early next year, and I am really looking forward to being able to share more data with you in the near future. So thank you very much.

At AAO 2021, Aerie Pharmaceuticals presented the results of their phase 2b clinical trial of AR-15512, a TRPM8 antagonist, for the treatment of dry eye.

Results from phase 2b study of AR-15512 for the treatment of dry eye

At the American Academy of Ophthalmology annual meeting, Marc Berger, COO of Verana Health, discussed the VeraQ quality measures dashboard for the IRIS registry report. It is anticipated to launch in 2022.

VeraQ is AI-enhanced health data engine that utilizes the Axon, AQUA and IRIS registries to report on unfiltered healthcare data. Additionally, it enable compliance with Merit-based Incetive Payment System (MIPS), meeting care quality measurements required by the Centers for Medicare and Medicaid Services (CMS). It also helps to identify patients who qualify for a clinical trial.

 Very excited to be here with everyone. In terms of the IRIS registry, I think this is the first year where Verana actually has been ingesting and curating data directly from participating practices.

So we are working end-to-end processing of EHR data, where we're partnering with practices and our technology on our platform, the VeraQ platform, brings in the data, and then organizes in a way which which more effectively processes the data and gives us a better sense of for analyzing this information. And in turn, we're able to then provide better insights, more accurate calculations for MIPS specifically, but then they're also use cases that are going to be developed on top of that.

So our use cases are developing particularly around the MIPS calculations and our quality measures. So participating practice will have better and more accurate information, accurate data, be able to run their practices more effectively, and ultimately treat patients with better care.

And that's really the, the keystone of what we're accomplishing over these past two years in our partnership with the AAO. The quality measures database is now being powered by our VeraQ platform. And this platform, like we discussed is more effective from a technological perspective. We've got proprietary algorithms using the data that's provided by participating practices. We're able to provide more accurate and more effective data sets which can then lead to better calculations for MIPS and better quality reporting, just giving doctors and the administrators as part of these practices, better information within their practices.

Verana Health showcases the VeraQ quality measures dashboard  for the IRIS registry report at AAO 2021.

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