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Clinical Focus

Ehsan Rahimy, MD, speaks on the highlights of a study he presented at this year's virtual AAO 2020 meeting that aimed to integrate an artificial intelligence screening system for managing diabetic retinopathy referrals in a primary care setting — with limited specialty support.



Read and watch more AAO 2020 coverage here

Ehsan Rahimy, MD, speaks on the highlights of a study he presented at this year's virtual AAO 2020 meeting that aimed to integrate an artificial intelligence screening system for managing diabetic retinopathy referrals in a primary care setting — with limited specialty support.

Integrating AI to manage DR in a primary care setting


Anne L. Coleman, MD, PhD, president of the American Academy of Ophthalmology (AAO), offers a preview of what attendees can look forward to from the academy's 2020 virtual annual meeting — kicking off Nov. 13-15 —including: in-depth information and innovations, free entry to the 17th annual Orbital Gala, open access to all 8 subspecialty days, new innovations, a first-ever talent show, extended access to content, and much more.


Read more about what to expect from AAO 2020


American Academy of Ophthalmology (AAO) President Anne L. Coleman, MD, PhD, offers a preview of what attendees can look forward to from the academy's 2020 virtual annual meeting — kicking off Nov. 13-15. 

What to expect from virtual AAO 2020


Ranya Habash, MD, medical director, Technology Innovation, Bascom Palmer Eye Institute, University of Miami, speaks with 

 Sheryl Stevenson on the capabilities of telemedicine available to ophthalmologists, the impact of the pandemic in regards to FDA regulations and how it’s helped to pave the way forward / expand telemedicine, as well as why the future of telemedicine requires a new way of thinking.

In this EyePod episode, Ranya Habash, MD, of Bascom Palmer Eye Institute, University of Miami, speaks on the expansion of telemedicine in ophthalmology amid the pandemic and why the future of telemedicine requires a new way of thinking.

Spotlighting telemedicine in the year of a pandemic

Matthew Starr, MD, discusses techniques for correcting astigmatism in patients lacking capsular support, enhancing visual outcomes surgery.

Q&A: Matthew Starr, MD, shares his experience using scleral suture toric intraocular lenses for patients with significant corneal astigmatism

Lai spoke with Modern Retina about the study of PER-001, a novel therapeutic targeting the endothelin-1 receptor.

ASRS 2025: Underfunding of Good Days program affect on patients and practices

Avant Technologies and Ainnova Tech refine clinical trial protocol for Vision AI platform, aiming for FDA 510(k) approval to enhance diabetic retinopathy detection.

AAC announces updated clinical trial protocol

Clearside Biomedical secures Health Canada approval for Xipere, while exploring strategic options to enhance its suprachoroidal delivery platform and pipeline.

Health Canada approves Clearside Biomedical's Xipere

Andrew G. Lee, MD, shares essential insights on neuro-ophthalmology for retina specialists, emphasizing diagnosis techniques and collaboration with neuro-ops.

Q&A: Andrew G. Lee, MD, shares what every retina specialist should know about neuro-ophthalmology

Lexitas Pharma Services' CMO discusses groundbreaking ophthalmology conference, emphasizing innovative clinical trials, emerging treatments for eye diseases, and the potential for transformative patient care strategies.

Ophthalmology Conference Highlights Novel Treatments and Innovative Clinical Trial Designs

David Tanzer, MD, Lexitas Pharma Services' CMO, met up with 

 to chat during the 2025 Retina World Congress annual meeting.

"This has been an amazing conference, and congratulations to the organizers and all the speakers who've learned so much – durable treatments for the bread-and-butter type of indications we heard yesterday about great treatments for geographic atrophy, including what are novel endpoints that are relevant to patients and regulators and payers," Tanzer said. "You know, from an anatomic and a functional perspective, we heard a little bit about inherited retinal diseases, cell and gene therapy, and really exciting space to be in right now."

He reflected on Dr. William Boyd, the FDA's current center director for the CDER ophthalmology head, introduced a paradigm-shifting perspective on clinical trial design, suggesting that pivotal studies no longer need to follow traditional parallel confirmatory models. Instead, researchers can now explore modified clinical trial designs that potentially broaden efficacy and safety endpoints, which could lead to more comprehensive treatment labels.

Lexitas is "a full service contract or clinical research organization," Tanzer said. "We're based in Durham, and we've been in this industry fully focused on ophthalmology for 14 years. I've actually only been the CMO for the last 2 months. I've been in ophthalmology for 30 years, but proud to represent Lexitas as their Chief Medical Officer, and really bring our knowledge, skills, abilities and partnership to sponsors, either strategics or small biotech companies emerging into this novel and dynamic space of ophthalmology, both in the posterior and anterior segment, both in devices and pharma. We're honored to partner with companies looking to bring novel treatment options for patients who need something to be new and proved and different, to help with their various diseases."

Videos

David Tanzer, MD, CMO of Lexitas reflects on Retina World Congress

Duke professor Sharon Fekrat envisions AI-driven ophthalmology with smartphone diagnostics and robotic procedures, emphasizing global collaboration and innovative medical research.

Value of collaboration in ophthalmology 

Sharon Fekrat, MD, a professor of ophthalmology and neurology at Duke University School of Medicine, highlights the critical importance of networking and collaboration in the medical field, particularly in ophthalmology. 

She emphasizes that international meetings are far more than just formal lectures and panels, serving as crucial platforms for building global connections and sparking innovative ideas. 

Many collaborations and projects evolve from informal interactions at these meetings. Fekrat said, "One example is a multicenter retrospective study on endogenous endophthalmitis that now has 8 centers across the United States. We are planning to incorporate international sites into this study group. Since etiologic organisms vary in different geographic locations, collecting such data is really important and can add to our understanding of endogenous endophthalmitis."

Fekrat specifically acknowledges Peter Weng, a Duke Medical Student soon to be an ophthalmology resident at the Wilmer Eye Institute, for his pivotal role in this research. 

"The future of ophthalmology is bright. So many in ophthalmology, including faculty, trainees, and industry, are very forward thinking, innovative, and entrepreneurial. Five years ago, we would have not been able to predict where we are today," she said.

Fekrat predicts a significant role for artificial intelligence in medical diagnostics and treatment.

"Going forward, AI is going to be a larger part of our workflow. I envision that patients will take retinal images with their smartphone that will be sent to the cloud, a diagnosis will be provided, and then they'll be told where to go to have a procedure by a robot," she concluded.

Duke professor Sharon Fekrat, MD, discusses AI-driven ophthalmology with smartphone diagnostics and robotic procedures, emphasizing global collaboration and innovative medical research.

Role of AI, global collaboration in ophthalmology's future

WIO 2024: An educator's perspective on shattering glass ceilings in ophthalmology

Fasika Woreta, MD, sat down with our editorial team to talk about her Women in Ophthalmology (WIO) Honorary Lecture and Award, "Shattering Glass Ceilings in Ophthalmology: An Educator's Perspective." 

Woreta is the Eugene de Juan, MD, Professor of Ophthalmic Education at Wilmer Eye Institute’s Baltimore and Columbia locations. She currently serves as the director of the Eye Trauma Center and the director of the Ophthalmology Residency Program at the Wilmer Eye Institute in Baltimore, Maryland.

Here are some of the highlights of Woreta’s discussion with Group Editorial Director Sheryl Stevenson.

Editor's note: The below transcript has been lightly edited for clarity.

 We are here today with Dr. Fasika Woreta, who will be attending this year's Women in Ophthalmology (WIO) Summer Symposium this weekend in Carlsbad, California. I know you're also presenting the WIO Honorary Lecture, so congratulations to you. Would love to learn a little bit more about your talk. What can you tell us?

 Thank you, Sheryl. I'm really honored to be giving the Honorary Lecture about shattering glass ceilings in ophthalmology, and I'm doing it from a perspective of a residency program director. So first of all, I'm really proud of Dr. Christina Weng, who is the current WIO president. So she was actually a year behind me in residency at Wilmer [Eye Institute], so to see her as professor at Baylor [College of Medicine] and president of WIO is just amazing, so speaking of shattering glass ceilings.

WIO has meant so much to me as an organization. All the leadership: it's just a terrific group of women who really bring each other up. So I will be talking about the current state of diversity in ophthalmology. This is sort of like preaching to the choir, to this group. And I think the group, Women in Ophthalmology, symbolizes what we need to do in terms of increasing diversity and shattering glass ceilings in terms of supporting each other. At this meeting, you can see it gives a forum for women to give presentations. They have a program for medical students, which has been hosted by Dr. Roni Levin and others. And so I'll be talking about some of these pathway programs within Women in Ophthalmology. So it's mentorship, opportunities for networking, giving speaking opportunities. Their award session is amazing to recognize contributions of mentorship, research, and education of its members. 

So I'll be talking about how we have now around 43% of women are in academia, in terms of when we look at the makeup and when we look at the medical student body, it's 55% so there is a disconnect between the diversity we see [in] the medical student body versus in women entering ophthalmology, as well as specifically in academia. And as we know, when you go up the ranks of leadership, we see a substantial decline in terms of the amount of women full professors. So that drops significantly from the 40% and then the chairs. So 20% of the chairs now are currently women, so it's definitely a lot better, but still a lot more to go in terms of that. So I'll be talking about barriers, which a lot of us are familiar with in terms of biases, harassments experienced in terms of lack of finding supportive mentorship, sort of institutional, structural inequities like lack of term limits that make it hard to advance. And so I'll be talking about that.

I really want to focus on solutions to reduce and continue to help shatter glass ceilings in ophthalmology, such as, again, a lot of the work Women in Ophthalmology is doing. There's a group at AUPO [that] Dr. Misha Syed and Dr. Rukhsana Mirza started called Women Professors of Ophthalmology. And so I feel, you know, the message is really for those in the audience, and there'll be a lot of trainees in terms of the necessary need for women in academia. Because in academia, we're sort of the gatekeepers of who enters the field. And the trainees need to see us in positions of leadership. Many chairs have women chairs like Dr. Kathryn Colby, Dr. Terri Young, Dr. Joan Miller, they've been an example for us in terms of and helped women greatly in terms of professional advancement and sponsorship. So that in the nutshell is of what I'll be talking about.

 What might be a key takeaway that you would really hope audience members take away from your lecture?

 I hope the many trainees in the audience hear what a great path it is for women in academia, and I hope many of them do join and become med student educators, residency program directors, chairs. And for those not in academia, you can see great examples of leaders in the private-practice setting in terms of industry or in the organizations like Women in Ophthalmology. And so there's a role for all of us to play, no matter what career setting we're in, in terms of promoting other women and helping the field advance. And then hopefully, in another 10 years, we'll see the number go from 20% women chairs to closer to what we're seeing in terms of women now being more common than men in US medical schools.

 As an educator, what strategies have you found to be most effective in empowering the next generation of ophthalmologists to really strive for leadership roles in the field?

 I think specifically in academia, it can be daunting, and again, for women facing additional challenges. But I think the strategies are first and foremost, which we'll all say is, is mentorship. So you know, many of us are in our positions today because of mentors, and it does certainly help to have female mentors as well. I feel if we don't see examples of females at our institutions, then you're not going to attract the best and brightest. So I would say mentorship, sponsorship. So the ability to be given opportunities to advance is something that women are good at giving other women I feel so they'll intentionally give opportunities. And you have to think about it, and again, be intentional about that. And so I think first and foremost is mentorship and sponsorship. 

And then also, again, programming is intentional programming, such as Women Professors of Ophthalmology, Women in Ophthalmology. We were looking at other groups like Women in Surgery, Women in ENT, but I do think that Women in Ophthalmology is the strongest example of a women in surgery group in terms of how fast the organization has grown and what the annual meeting has become as well as all the activities that go on all year.

 Anything else to add that we haven't touched upon?

 I'm taking my family along. Women in Ophthalmology also kind of represents...They have special programming for kids, and they're really family friendly, so I think it really sort of embodies what meetings should be like. And I think the American Academy of Ophthalmology is going to have childcare this year. II think welcoming families is also an important part and providing flexibility.

So actually, we saw for the board examination for the number of women board examiners went up once we had flexibility in terms of virtual opportunities to examine. So now the board exams are all virtual as well as flexibility in terms of the number of days that you need to be an examiner. So it used to have to be, I think, 3 days in a row in person, but now it's virtual and you can choose 2 days for 8 hours, for example, so you can see that allowed for flexibility. And then when we saw the number of women examiners jump significantly with the advent to virtual so I think thinking about how to make things flexible, incorporate families, I think can help relieve sort of burnout and a lot of the barriers that women in our field face.

Fasika Woreta, MD, spoke about shattering glass ceilings in ophthalmology, highlighting the importance of diversity, mentorship, and empowering women in leadership roles within the field during her WIO Honorary Lecture and Award.

Hannah Chiu, MD, FRCSC, highlights some of the early benefits of an AI-operated telephone call system for postoperative patient care at WIO 2024

WIO 2024: Integrating AI for postoperative patient care

Hannah Chiu, MD, FRCSC, sat down with our editorial team to provide an overview of an AI-operated telephone call system for routine postsurgical follow-up, which has shown safety, efficacy, and acceptability in both the UK and Canada. The AI call helps identify red flags and reduces the need for in-person visits, saving patients travel and family members' time off work. Patient feedback has been positive, with an 8 out of 10 recommendation score, Chiu adds. Although this study is being conducted among patients who have received cataract surgery, the hope is that similar AI postoperative care may be implemented for other types of surgical procedures. Here are some of the highlights of Chiu’s discussion with Group Editorial Director Sheryl Stevenson.

 We are joined today by Dr. Hannah Chiu, who is among the presenters at this year's Women in Ophthalmology summer symposium in Carlsbad, California. Welcome to you!

I know you're going to be giving a talk about how to integrate artificial intelligence or AI into the practice and talking about postoperative patient care. What can you tell us about your talk?

 Well, thank you again for the opportunity to share a little bit about my talk, Sheryl. I'm really honored to be able to present on this innovative enhancement to taking care of our patients. So essentially, Dora is an AI-operated telephone call, because I think right now, we are on the bridge working with patients who are probably more elderly, less exposed to technology, and we really needed an application that was easy for them to use. So even though there's the term AI or artificial intelligence, this is also just a regular, old-fashioned telephone call that goes to patients at the postoperative week 1 for routine cataract surgery.

I'm based in Canada, and I'm not sure if some of our listeners are aware, but our geography is quite large. We also have wintry climates. One of the reasons why we really wanted to look into the safety and efficacy and acceptability of AI in this situation is because for patients to travel, to take time off, and also during the wintry conditions sometimes can be a challenge. And so this is something that has been shown, both in the UK and now in Canada at our site, to be safe and acceptable to patients.

 That's wonderful. I was curious, too, what are some of the current AI applications in ophthalmology for postoperative care? This is definitely one of them. Are there other applications others are using?

 I'm not 100% sure about that. It would be nice to learn more about what others are using at this time. Just to expand a little bit of how the AI phone call works, essentially, the patient gets a phone call, and it's a language model where Dora asks questions that are standard to red flags that might come up postop that would flag a necessity to come in for a face to face in-clinic visit versus just a phone call. So this is only for patients who had a standard, routine cataract surgery.

 What are some of the other benefits that you've observed personally when integrating AI into postoperative patient care?

 I think first, like we talked about saving patients from having to travel long distances or in wintry climate, part of the inspiration for this was born out, of course, everything has been touched by the pandemic, but trying to limit in-person visits where there's long wait times, and freeing up time for clinicians to be able to then use that time to see patients that do need to be seen in person. The other thing, too, is for patients themselves. Oftentimes, they come with someone who needs to take time off work, and so that saves time for their family members not to have to take time off work to come with them to the visit.

 Absolutely. A lot of benefits there as well. How are patientsresponding to this use of AI?

 So generally, very positively. So we have at the end of the phone call, just a quick survey about how likely they were going to recommend this kind of follow-up visit with the phone call to their friends or to their neighbors. And the score was 8 out of 10. So it was very acceptable, even among patients who generally may not be as accepting of new technology, or may have other may have difficulties transitioning to something that is more technology based. So that's been very promising and very reassuring.

 Are there other AI tools that you think you might consider in the future, or even just expanding this current application even further in another way?

 Because right now it's more still in the study phase, the standard of care is still to see the patient in person. So hopefully in the future, it does actually become the standard of care. It is right now in the UK, in a lot of the centers that they were able to show that it isn't necessary for patients to come in for the postoperative week 1 visit in person for the patients who pass the AI phone call. So that would be one of those policy-changing things that we hope that this could be applied for, but it may be a few years down the road for that to be implemented.

 That actually leads into my next question. I was curious what your thoughts were, how do you see AI evolving into the context of postoperative care 5 or 10 years from now?

Right now it's still a conversation to a patient, pick up the phone call and AI Dora is learning how to sort of speak and answer questions, too. It may not just be looking for symptoms that are concerning, that warrants a visit in person, but also just answering questions about how to take drops, answering questions about what's the next step, when's my next surgery, those kind of things. So it's definitely a language model that's learning each time that patients give it feedback in terms of questions, what kind of answers it needs to come up with. So that's really exciting, and that's in our phase 2 trial.

 Anything else to add that we haven't touched upon? Any further research or anything like that?

 I think maybe in the future, hopefully it expands beyond cataract surgery. I mean, cataract surgery is the biggest portion of ophthalmic surgery. But maybe in the future, other types of surgery, surgical procedures, maybe that can be implemented for postoperative care there, too. So we're looking forward always to more collaboration across some specialties in ophthalmology.

Hannah Chiu, MD, FRCSC, highlights some of the early benefits of an AI-operated telephone call system for postoperative patient care.

Retinal Inner Layer Disorganization and OCT in Uveitic Macular Edema: Insights from Dr. Amitha Domalpally

Amitha Domalpally, MD, PhD, sat down with 

 to discuss how disorganization of retinal inner layers affects OCT outcomes in cases of uveitic macular edema. Domalpally shares some of the research highlights here with Group Editorial Director Sheryl Stevenson.

- The following transcript has been lightly edited for clarity.

We are here today with Dr. Amitha Domalpally. And we'd love to talk more about ARVO and the presentations that are coming up here very quickly. One in particular is regarding the POINT [PeriOcular vs INTravitreal corticosteroids for uveitic macular edema] study.

What can you tell us about the association of DRIL—disorganization of retinal inner layers—with OCT outcomes in uveitic macular edema?

Thank you, Sheryl. Thanks for introducing me. I am the Research Director of the Wisconsin Reading Center [Department of Ophthalmology and Visual Sciences, University of Wisconsin System, Madison, Wisconsin]. The Wisconsin Reading Center was the image analysis center for the POINT study, which is a periocular versus intravitreal corticosteroids for uveitis. It's a National Eye Institute-sponsored study. It's a grant looking at treatments for uveitic macular edema, a disease that is not studied so much. We are grateful that NIH sponsored the study and were able to look at treatments.

This study was completed about a year ago and the publications on primary results are out. Essentially, steroids work great for uveitis. They do improve vision...and this was all kinds of uveitis was studied in this POINT study and steroids work well for uveitis and retinal thickness as measured by OCT was also reduced. We had both anatomical and visual benefits with steroid treatment. The safety was also assessed as part of the study.

Now, because there was this rich collection of images collected as part of the clinical trial, including OCT scans on a monthly basis, we sought to understand are there other markers that can help us identify patients who improve and those who don't early on, because the treatment works but not in everybody as always. We wanted to see are there other imaging biomarkers that can help us identify these.

So that's kind of how we undertook this whole DRIL analysis and everything which is been done in diabetic macular edema, in retinal vein occlusion, and has been shown to be associated with visual recovery. If you have DRIL, it's a poor prognosis for vision recovery. It's a bad biomarker. We wanted to see if in uveitis the same thing holds because uveitis is a different disease as we know. Anti-VEGFs don't work for uveitis just like everything else. We know the macular edema has a different physiology. It's inflammation related. We wanted to know: does it work at all?

 It's fascinating research. Can we take a deeper dive in terms of the outcomes and what these mean for retina specialists and their patients?

 Yeah, so DRIL is a difficult biomarker. It requires one to look at the OCT scans carefully, because it is those specific layers that we need to look at between the ganglion cell layer and the outer plexiform layer. Those are not easy to figure out, especially in uveitis when there's so much inflammation and there are cysts and there's edema and thickness and the anatomy of the eye is distorted. It's hard to see. We had our reading center graders, who are trained in this, look at this carefully. What they found was that DRIL is very, very common. In uveitis, we found almost 80% of the eyes had DRIL so this biomarker was present. In a lot of the eyes, these eyes had a lot of edema, so there were cysts in the eye and the cysts can be a little bit of a confounder and make real assessment a little difficult. Nevertheless, we said okay we did our best and we found that yes, 80% of the time you have DRIL. Then we wanted to see in eyes with DRIL what happens over time.

One, overtime does this DRIL stay the same or does it change? does it go away? Because in diabetes and vein occlusion, it doesn't go away. Once you have DRIL, it's forever. We wanted to see in uveitis what happens. Does it go away? Or does it stay?

The second thing we wanted to see is how does DRIL correlate with OCT thickness. Does it come down or not? And what we found is that, yes, high rate of DRIL 80% have DRIL. DRIL was associated. So when you had DRIL you had a very thick retina. Most of these eyes were 500 microns, which is a very thick retina. Most of them had cysts, most of them. We even looked at the photoreceptor status in these eyes and most eyes, which had DRIL also had this photoreceptor disruption and ellipsoids own disruption, which is a new biomarker that everyone's interested in. So eyes with DRIL overall were more diseased than eyes without so that was the baseline.

And then we looked at what happens over time. Interestingly, what we found was if you don't have DRIL in the beginning, at baseline, you don't have DRIL throughout. We followed these eyes for nearly 4 months (12 weeks) and 3 months and they don't have DRIL. If you don't have DRIL, you're good. You don't have DRIL forever. But if you have DRIL, nearly half the eyes seemed to recover from the DRIL. So it disappeared over time. All was not lost if you had DRIL in the beginning. What we think is the reason is because the eyes in the beginning are a little more diseased. If you wait a little, maybe a month, and then assess DRIL it might give you a better understanding of how severe the eye is anatomically affected. That's what we thought. So about half the time DRIL goes away. So that was longitudinal.

The third thing we looked at was thickness. With thickness, what we found was that because these eyes with DRIL were very thick in their central subfield thickness, about 500 microns, they seem to come down much more. They became flatter, so they had much more to lose in terms of thickness. We had about 35% improvement in the central subfield thickness in eyes with DRIL compared to about 15%. So about half of that in eyes without DRIL. Those were our three major findings. Lots of eyes with DRIL. If it's not there, it's not there, but if it's there, it goes away 50% of the time, and thickness does come down even in eyes with DRIL.

 That's certainly fascinating research. Is there anything else that you'd like to add that we haven't touched upon

 I think one of the things we want to continue to do is DRIL, what does it do for vision and that is upcoming. For ARVO all we focused on was the OCT. We are going to go ahead and do vision correlations and extend this into an upcoming publication.

Amitha Domalpally, MD, PhD, discusses how disorganization of retinal inner layers affects OCT outcomes in cases of uveitic macular edema.



ARVO 2024: What retinal specialists can learn about DRIL from the POINT study 

ARVO 2024: Study Reveals Faricimab's Potential for Extended Dosing in nAMD

 to discuss extended treatment outcomes and the potential for Q20W dosing with faricimab in nAMD from a post hoc analysis of the pivotal TENAYA/LUCERNE trials. He shares some of the highlights here with Group Editorial Director Sheryl Stevenson.

- This transcript has been edited lightly for clarity.

We are joined today by Dr. Philip Storey, who will be presenting at ARVO this year. Welcome! So delighted to have you. We'd love to hear more about the post hoc analysis regarding the TENAYA and LUCERNE trials. What can you tell us?

First of all, thank you so much for having me. I really appreciate being on. We did a post hoc analysis looking at outcomes from TENAYA and LUCERNE [NCT03823287 and NCT03823300], which of course is the pivotal phase 3 clinical research study looking at faricimab, the first bispecific antibody used for wet macular degeneration.

And first of all, we looked at those patients. As you all know, this was a 2-year study that looked at faricimab versus aflibercept [Q8W aflibercept]. And then the faricimab patients were extended pretty aggressively actually to a very impressive point. Over almost 80% of patients (77% of patients) were able to get to a Q12W or Q16W interval by the end of this study. The point of this analysis was really to look at patients who had been extended, who'd completed all the way up to that Q16W extension and say, hey, if we applied the same treatment criteria that we used previously to extend patients, how many of these patients could we potentially have gotten to Q20W dosing for wet macular degeneration, which is sort of an unheard of interval for clinical studies.

The results were pretty impressive. What we did...the first year of the study had a fixed-interval dosing. Patients were either treated at Q12W or Q16W, then they have very specific algorithms for patients that need to be moved backwards. Basically, if the fluid increased or the vision dropped or there was new hemorrhage on the back of the eye, then that interval was decreased. The patients who were stable were increased. Whenever we got to the second year, treat-and-extend period, that's when we could see more of an extension.

This study looked at patients who had successfully completed...had one complete interval of the Q16W dosage, and we looked to see could these patients have been extended longer? The answer is 'yes' for quite a few of them: 56% of patients in this post hoc analysis would have qualified for extension to a once every 20 week dosing, which was pretty impressive. About 44% of patients still didn't qualify for that extension. That was usually because of anatomical changes, increase in CST [central subfield thickness]. But the majority of patients could.

Then we took another look at who are the patients who are more likely to be extended...could have been extended to that every 20 week interval? And the answer was patients with less fluid and lower PEDs [pigment epithelial detachments], which makes a whole lot of sense. You have less fluid. There's a greater chance of getting rid of that fluid and therefore extending the patient.

This was really impressive data. They of course didn't have a Q20W arm in the study but it looks like they could have and they could have been quite successful with over half of patients. So very impressive data with faricimab and I'm thrilled to present it at ARVO.

Thanks for that update. That's really fascinating. What does this research mean for retina specialists and their patients?

Yeah, good question. This means that we have good data that we can go longer between intervals than we ever thought we could...that if we're able to get a patient dry and maintain their vision. Historically, with first-generation medications a lot of us weren't really comfortable extending past 12 weeks—risk of hemorrhage or risk of loss of vision. This is good strong data that says maybe particularly with the second-generation medications, specifically faricimab, we can go longer than we ever have before. You know, coming to see your doctor once a month...I love seeing my patients but they hate coming to see me. It's a burden. A lot of our patients are elderly. They can't drive. They rely on family members. So the longer we can go between injections, the better it is for our patients.

Fantastic. Anything else to add that we haven't touched upon?

It's exciting times in retina. We are making big leaps forward, and I'm just excited to continue to provide amazing care for our patients. Thank you very much for having me on.

Philip P. Storey, MD, shares the highlights of his ARVO presentation on a post hoc analysis of the pivotal TENAYA/LUCERNE trials.

ARVO 2024: Extended treatment outcomes and the potential for Q20W dosing with faricimab in nAMD

 This transcript has been lightly edited for clarity.

Hi, my name is Scott Walter. I'm a retina specialist in Hartford, Connecticut. And I wanted to talk today a little bit about the year 2 data from the TENAYA and LUCERNE trials.

So TENAYA and LUCERNE were the phase 2 pivotal clinical trials leading to the FDA approval of faricimab for the treatment of patients with neovascular AMD. And in year 1 of the trial, we know that patients got 4 monthly loading doses of faricimab and then patients went into extended treatment arms of 8-, 12-, or 16-week fixed dosing intervals. And that was based on disease activity assessments that took place at week 20 and 24.

In year 2 things changed a little bit in terms of the protocol. So beginning at week 60, patients were eligible to extend or shorten their treatment intervals based on disease activity assessments occurring at each study visit. So this became more of a treat-and-extend type protocol, patients could go ahead by 4 weeks or back by 4 to 8 weeks depending on those disease activity assessments. So I think what happens in year 2 is very interesting to us as retina specialist because it kind of—it reflects maybe how we practice in the real world with a treat-and-extend practice pattern.

So in year 2, 60% of patients were able to extend their dosing interval by 4 more weeks, and the vast majority of patients maintain those dosing intervals through the end of year 2 at 112 weeks.

Ultimately, the number of patients who are maintained at Q-60 week dosing intervals increased from 45% at the end of year 1 to 63% at the end of year 2. So it's really impressive how, you know, the the numbers just keep going up in terms of the proportion of our patients who can be maintained at these extended dosing intervals, about 4 out of 5 patients can be treated in a Q-12 to 16 week dosing intervals, throughout 2 years of treatment with faricimab.

So I think this new therapy really has tremendous promise, the best corrected visual acuity gains and central subfield thickness reductions that were observed in year 1 were maintained in year 2, there were no significant safety signals, low rate of intraocular inflammation and really, absolutely no cases of inclusive or non-inclusive retinal vasculitis identified in the second year of the trial.

So I think this gives us a lot of confidence as retina specialists, as we begin transitioning some of our patients from other anti-VEGF therapies to this new molecule, which is both an anti-VEGF agent and a dual pathway inhibitor that also blocks Ang-2 that we can really achieve extended durability in the vast majority of our patients.

Scott Walter, MD, an investigator in the TENAYA and LUCERNE trials discusses the year 2 data for the treat-and-extend regimen of faricimab for the treatment of nAMD and DME.

TENAYA, LUCERNE year 2 data reveals promising results for faricimab

 This transcript has been lightly edited for clarity.

 Hi, I'm Carl Danzig, from the Rand Eye Institute, in Deerfield Beach, Florida. I'm excited to be here today in Chicago for the American Academy of Ophthalmology. It's so great to be here in person.

You know, the one topic that I have a lot of passionate about, amongst others, is dry AMD with geographic atrophy. I expect this will be a widely discussed topic here at today's meeting. Later today, there'll be multiple presentations in the breakout development section and early clinical trial results section. So I'm excited to highlight that, you know, the one thing about this huge unmet need in the retina space is, well, how do we identify it? How do we diagnose it, and I use the Heidelberg Spectralis machine to identify geography attribute using the OCT, and fundus autofluorescence imaging. 

I also use the region finder to identify the size of the lesion and map its growth compared to prior images. This allows me to better diagnose these patients. It allows me to see which pages may be enrolled in the clinical trial, which patients may be best suited for, hopefully, an emerging therapy that could come out next year. And the more that we can diagnose these patients, the better it is.

Furthermore, so many of these patients exists outside of the retina specialist’s practice, and though they do take up a fair amount of patients in my clinic schedule, a lot of these patients live in other doctor's offices, whether the optometrist or the general ophthalmologist. And the sooner that people can identify these patients, the sooner we can get them treated hopefully, and preserve their vision. Because the goal of treating GA over the long term is to preserve their central vision. Help them see clearer, longer.

Carl Danzig, MD, points out that the sooner patients can be diagnosed, the sooner ophthalmologists can treat them and preserve their vision. 

How to diagnose geographic atrophy earlier

Oct. 14, 2022, marks the 22nd World Sight Day (WSD), an annual day of awareness, held on the second Thursday of October, to focus global attention on blindness and vision impairment.

"This is a day where we focus the world's attention on the importance of eye care," Constance Okeke, MD, MSCE, of the Virginia Eye Consultants said.

Coordinated by the International Agency for the Prevention of Blindness (IAPB), the international day of awareness is a reminder to "love your eyes."

As part of its efforts, the IAPB and its members are working together to increase public awareness on vision issues and blindness, calling for a focus on vision issues and eye health.

As part of the WSD campaign, IAPB urges eye care professionals, including ophthalmologists and optometrists, to get involved.

"I think it's a great way to advocate and communicate for our patients and for what we do as optometrists; we make a big difference in our communities, and to patients' lives, and I think all optometrists should be celebrating World Sight Day," said Maria Sampalis, OD, owner of Sampalis Eye Care in Cranston/Providence, Rhode Island.

Today, IAPB is promoting a global challenge to unite the world, bringing people across the globe together to have their eyes tested. This year, IAPB is leading the call for people to prioritize their eye health and asking the world’s leaders to ensure eye care is accessible, available, and affordable to everyone everywhere.

"World Sight Day means a little bit different for me, not being from here originally," Adam Ramsey, OD, co-founder of Black EyeCare Perspective, said. "Understanding that the gift that we have—in this wonderful country that we're living in right now—where there is access to care so readily available."

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World Sight Day 2022: Eye care professionals share what global vision means to them

This transcript has been lightly edited for clarity.

Tom Ruggia, President and CEO of Samsara Vision, provides updates on the lead asset for late-state age-related macular degeneration: Smaller-incision, new generation, implantable miniature telescope (SING IMT).

Ophthalmology

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