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ASRS 2025: Racial and ethnic disparities in retinoblastoma treatment options

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Opioids like fentanyl effectively prevent sneezing during propofol sedation for periocular injections, enhancing patient safety in ophthalmic procedures.

Using opioids to prevent sneezing and potential ocular tissue damage during sedation and periocular injections

assistant professor of ophthalmology at the Atrium Health Wake Forest Baptist School of Medicine

ASRS 2025: Neighborhood-level characteristics associated with delay in surgery and loss to follow-up

Discover how dropless vitrectomy with suprachoroidal injection effectively controls inflammation, offering a promising alternative to traditional eye drop therapy.

ASRS 2025: Dropless vitrectomy with suprachoroidal triamcinolone-moxifloxacin

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Ophthalmology Times – Clinical Insights for Eye Specialists

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This PER On Air - Ophthalmology Times podcast examines the new treatment paradigm for patients with geographic atropy, following the introduction of complement-targeting therapies. In this podcast, experts, Dr Cecelia Koetting and Dr Talia Kaden review some of the key highlights from the live satellite symposium, Community Practice Connection™: Mastering the New Treatment Paradigm in Geographic Atrophy – From Detection to Intervention presented at the 2024 EnVision Summit in Ophthalmology.

Northwell Health and the Manhattan Eye, Ear and Throat Hospital (MEETH)

University of Colorado School of Medicine

This PER On Air - Ophthalmology Times podcast examines the new treatment paradigm for patients with geographic atropy, following the introduction of complement-targeting therapies. 

Mastering the New Treatment Paradigm in Geographic Atrophy – From Detection to Intervention

 EyePod podcast, Mandeep S. Singh, MD, PhD, speaks with Mark S. Humayun, MD, PhD, to learn about the advancements for a novel stem cell patch developed by a team of researchers at USC for the treatment of advanced dry age-related macular degeneration.

Dr. Humayun talks about the inspiration behind the patch, how his expertise in both ophthalmology and biomedical engineering has been crucial, and insights gained from a Phase 1/2a study. Dr. Humayun also outlines the upcoming steps for a multisite Phase 2b clinical trial and envisions the potential future role of the stem cell patch in the treatment of geographic atrophy.

Associate professor of ophthalmology and genetic medicine at the Wilmer Eye Institute at Johns Hopkins University School of Medicine in Baltimore, Maryland

Recipient of the 2023 Andreas C. Dracopoulous Professorship in Ophthalmology

Co-Director of the Genetic Eye Diseases (GEDi) Center and principal investigator at the Center for Stem Cells and Ocular Regenerative Medicine (STORM)

University Professor of Ophthalmology, Keck School of Medicine of USC in Los Angeles, California

Cornelius J. Pings Chair in Biomedical Sciences

Director, USC Ginsberg Institute for Biomedical Therapeutics

Received the National Medal of Technology and Innovation from President Barack Obama in 2016 for his innovative work and development of the Argus II.

In this Ophthalmology Times EyePod podcast, Mandeep S. Singh, MD, PhD, speaks with Mark S. Humayun, MD, PhD, about the progress made by a team of USC researchers on a novel stem cell patch for treating advanced dry age-related macular degeneration.

Innovation Series: A stem cell patch for treating advanced dry AMD

 EyePod podcasts focusing on innovation in ophthalmology. Throughout this series, we'll be hearing insights from various stakeholders including those in clinical practice, academia, and industry. The overarching message in this podcast is intended to be informational and not promotional. Today, our host Ehsan Sadri, MD, engages in a conversation with Jeffry Weinhuff, who is managing partner of Visionary Ventures. And just a quick note: the thoughts and opinions expressed are those of the speakers and do not necessarily represent the opinions of this publication.

 in Newport Beach, California, and is board-certified, fellowship-trained in treating LASIK, cataract, and glaucoma surgeries. He is a co-founder of Visionary Ventures Fund and a consultant to Tarsus.

, a series of venture capital funds which is a leading investor in drugs and devices for the eye. Visionary has current financial interests and serves on board of directors of the following companies: Aurion Biotech; Centricity Vision; CorneaGen; IanTrek; ONL Therapeutics; Orasis Pharmaceuticals; Pelage Pharmaceuticals; Re-Vana Therapeutics; Surface Ophthalmics; Sydnexis; Surface Ophthalmics; TearClear.

Explore cutting-edge ophthalmology innovations in this new series on the Ophthalmology Times EyePod podcast. Throughout this series, we'll hear insights from various stakeholders in clinical practice, academia, and industry. In this episode, host Ehsan Sadri, MD, engages in a conversation with Jeffry Weinhuff, managing partner at Visionary Ventures, exploring trends and offering advice for individuals driven by an entrepreneurial mindset.

(EyePod) From idea to impact: Navigating ophthalmic innovation

Fovea-sparing, multifocal, and bilateral lesions exhibited the fastest growth rates.

Study establishes reference data set for geographic atrophy lesion progression

Omer Trivizki discusses promising results of VOY-101, a gene therapy for geographic atrophy, highlighting safety and next steps in ongoing research.

Q&A: First time results of VOY-101 for geographic atrophy

Eyestem Research secures $10 million funding to advance innovative retinal therapies, aiming for global expansion and promising trial results.

Eyestem closes $10 million (USD) funding round

Dr. Nimesh A. Patel reveals key findings on pegcetacoplan and anti-VEGF treatments for geographic atrophy and neovascular AMD at ASRS 2025.

Q&A: An analysis of patients who received pegcetacoplan and anti-VEGF for GA and wet AMD

Re-Vana and Boehringer Ingelheim launch $1B collaboration to develop extended-release eye therapies

ASRS 2025: ARCHER II, a phase 3 randomized clinical trial of ANX007 in patients with dry AMD and GA: Study design and rationale informed by outcomes from ARCHER

David Eichenbaum, MD, FASRS, a partner and director of research at Retina Vitreous Associates of Florida and collaborative volunteer Associate Professor at the Morsani College of Medicine, University of South Florida, presented at the American Society of Retina Specialists (ASRS) meeting in 2025 about the ARCHER-2 study. 

The presentation focused on 4 key takeaways about the study. First, the ARCHER-2 study had completed its enrollment, with the next phase being patient retention and result analysis. Eichenbaum emphasized that the study was fully enrolled and ready for the next steps. The study was designed with a unique visual-functional endpoint, specifically an event analysis of 15-letter loss. This approach potentially offered a global pathway for approval of a geographic atrophy drug with a meaningful visual-functional endpoint. This was significant because it represented a potential breakthrough in treating geographic atrophy. 

The phase 3 trial built upon the phase 2 trial's inclusion criteria, which focused on center-involving and non-center-involving geographic atrophy. The study excluded patients with visual acuity better than 45 letters (20/100), while allowing center-involving geographic atrophy as an inclusion criterion. This methodology was intended to improve the probability of meeting the study's endpoint. 

Eichenbaum highlighted the study's potential to be the first globally approved therapy for geographic atrophy that demonstrated a meaningful change in visual function. He acknowledged that while geographic atrophy treatments existed, there was still considerable room for improvement in the field. The researcher expressed excitement about the future of geographic atrophy treatments, noting the significance of the ARCHER-2 study in advancing medical understanding and potential treatment options. He viewed the study as a critical step forward in addressing the challenges of geographic atrophy. 

The primary goal remained to retain patients and carefully analyze the results, with the hope of providing a significant advancement in treating this challenging medical condition. Eichenbaum's presentation underscored the potential for meaningful progress in ophthalmological research and treatment.

ASRS 2025: ARCHER II, a phase 3 randomized trial of ANX007 in patients with dry AMD and GA

ASRS 2025: Roger Goldberg, MD, MBA, on the 48-month results from OAKS, DERBY, and GALE open-label extension study

Roger A. Goldberg, MD, MBA, from Bay Area Retina Associates presented 48-month data on pegcetacoplan for geographic atrophy (GA) treatment at the ASRS 2025 conference in Long Beach, California. 

The research stems from the DERBY and OAKS clinical trials, which transitioned into an open-label extension study called GALE. The study's key findings reveal significant advances in preserving retinal tissue through continuous treatment. In the non-subfoveal population, monthly treatment preserved 3.16 square millimeters of retinal tissue over 4 years, while every-other-month treatment preserved 2.77 square millimeters. Notably, the treatment's effectiveness increased over time, with greater tissue preservation and slower GA growth in years 3 and 4 compared to the initial 2 years. 

Patients who delayed treatment saw markedly less benefit. Those who waited 2 years before starting treatment only preserved 1.1 square millimeters of retinal tissue, compared to those receiving continuous treatment. The microperimetry data demonstrated a compelling 35% risk reduction in early-treated patients, particularly in the critical central 4 and 16 loci of vision. 

The safety profile remained consistent with previous studies, supported by an impressive real-world dataset of over 700,000 pegcetacoplan injections, including more than 100,000 new treatment starts. This extensive real-world experience provides a robust safety compendium and validates the long-term treatment approach. 

The research underscores the importance of early and continuous intervention in managing geographic atrophy. By preserving retinal tissue and reducing the risk of absolute scotoma progression, pegcetacoplan offers a promising therapeutic strategy for patients with this degenerative condition. Goldberg's presentation highlights the potential of targeted, long-term treatment in slowing geographic atrophy's progression, offering hope for patients by maintaining critical visual real estate and potentially improving long-term visual outcomes.


The 48-month data on pegcetacoplan for geographic atrophy (GA) treatment, presented by Dr. Roger A. Goldberg, highlights significant advancements in retinal tissue preservation. The DERBY and OAKS trials, followed by the GALE extension study, demonstrate that continuous treatment is more effective than delayed intervention, with greater tissue preservation and slower GA progression in later years. Early treatment reduces the risk of vision loss, as evidenced by microperimetry data. The safety profile is consistent with previous studies, supported by extensive real-world data, validating the long-term treatment approach.

ASRS 2025: 48-month results from OAKS, DERBY, and GALE open-label extension

Safety and efficacy of OCU410 for treatment of geographic atrophy: Phase 1/2 Study Update from Jay Chhablani, MD

Jay Chhablani, MD, Vice Chair at the University of Pittsburgh Medical Center, presented the phase 1/2 clinical trial data for Ocugen's OCU410, at the 2025 annual meeting of the American Society of Retina Specialists. This meeting was held in Long Beach, California from July 30 through August 2, 2025.

The presentation highlighted several key findings from the research. The study's safety profile was particularly noteworthy, with no serious adverse events reported during the 12-month follow-up period. Researchers observed significant therapeutic benefits, including a more than 40% decrease in lesion size and a four-line improvement in low luminance visual acuity. 

Chhablani emphasized the unique characteristics of this gene therapy approach. The treatment was delivered subretinally, requiring a single surgical intervention rather than repeated monthly injections. He described it as an almost "one-and-done" therapy that could effectively slow disease progression. The subretinal delivery method involved introducing the drug in the peripheral retinal area. 

While some pigmentary changes were expected in the initial follow-up period, these changes were not anticipated to significantly impact patient vision due to the treatment's specific location. The research team was optimistic about the therapy's potential. 

The Phase 2 enrollment had already been completed, and Ocugen is preparing to launch Phase 3 trials in the first quarter of 2026. This progression suggested promising next steps for the treatment's potential clinical application. The gene therapy's approach represented a potentially transformative method for managing dry macular degeneration. By offering a single surgical intervention that could provide long-term benefits, the treatment offered hope for patients seeking alternatives to ongoing, repetitive treatments. The presentation concluded with a sense of excitement about the future possibilities of OCU410, highlighting its potential to provide a more convenient and potentially more effective treatment option for patients suffering from this degenerative eye condition.

Jay Chhablani, MD, presented the phase 1/2 clinical trial data for OCU410, at the 2025 annual meeting of the American Society of Retina Specialists. 

ASRS 2025: Phase 1/2 study update on OCU-410 for geographic atrophy

Dilsher Dhoot, MD, on the evolution of geographic atrophy therapy: where are we now?

Dilsher S. Dhoot, MD, FASRS, provided an update on the current treatment landscape for geographic atrophy (GA) in a recent interview with the Eye Care Network. “Geographic atrophy causes progressive and irreversible vision loss,” he noted, emphasizing the clinical urgency given that the median time to foveal involvement is approximately 2.5 years from diagnosis.

Dhoot is a retina specialist with California Retina Consultants and an adjunct clinical assistant professor of ophthalmology at the Keck School of Medicine at the University of Southern California in Los Angeles. 

The year 2023 marked a significant shift with the FDA approvals of pegcetacoplan, a complement C3 inhibitor, and avacincaptad pegol (ACP), a complement C5 inhibitor. Both therapies target dysregulation in the innate immune system’s complement pathway, with the aim of slowing GA lesion progression. “We’re regulating complement and thereby allowing these GA lesions to grow slower,” he said.

Dhoot reviewed key data from the pegcetacoplan program, including the OAKS and DERBY phase 3 trials and the GALE open-label extension. Over 48 months, pegcetacoplan showed increasing benefit: “We saw in the last 24 months... a 28% reduction in GA growth,” compared with 19% to 18% in the initial 24 months. The most notable tissue preservation occurred in nonsubfoveal lesions, with up to 3.16 mm² of preserved area by month 48.

ACP’s efficacy was demonstrated in the GATHER 1 and 2 trials, which enrolled only nonsubfoveal patients. “We see again a reduction in the growth of the GA lesions,” Dhoot said, highlighting a 35.4% reduction in GATHER 1 and 17.7% in GATHER 2 at 12 months.

Safety profiles were generally favorable, he noted. Pegcetacoplan has a low incidence of injection-related vasculitis (1 in 4000), and both agents show a dose-dependent risk of choroidal neovascularization.

Dhoot emphasized patient education: “These drugs don’t improve vision… They just slow them down.” He also noted the need for more durable and effective therapies, adding, “We’re just at the beginning of the evolution of GA treatment.”

Dhoot D. Update on current treatments for geographic atrophy. Presented at: Sonoma Eye 2025 Meeting; March 20-23, 2025; San Diego, CA.

A look at current therapies, clinical trial results, patient education, and emerging options for managing this progressive retinal disease.



Dilsher S. Dhoot, MD, FASRS, on the landscape of geographic atrophy therapy

ARVO 2025 Roger Goldberg

At ARVO 2025, in Salt Lake City, Utah, Roger Goldberg, MD, MBA, talked about his presentation on the effect of AREDS vitamins in geographic atrophy.

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

Hi, I'm Roger Goldberg from Bay Area Retina Associates in Walnut Creek, California. And it's great to be here at ARVO 2025 in Salt Lake City, Utah. Today, I had the pleasure of presenting data on the effect of AREDS vitamins in geographic atrophy.

We know that the original AREDS studies, AREDS1, which kind of ran over the 1990s and was published in early around 2001 and then AREDS2, which made some slight tweaks to the formulation, ran the 2000s, and was published, I think around 2012/2013. Those showed a reduction in the progression to advanced AMD. But if you look closely at the data, that reduction in progression of advanced AMD from stage 3 or 4, kind of intermediate AMD, was largely driven by reducing the conversion to wet macular degeneration or neovascular AMD. And not really on the development or progression of geographic atrophy.
Recently, just earlier this year, there was a paper published a posthoc analysis of AREDS1 and AREDS2 that looked at, again, kind of a sub group analysis of patients who either developed GA over the course of AREDS1 and AREDS2 or who had some incipient GA and how did it progress over time. And in that posthoc analysis, which is a couple 100 patients, a couple 100 eyes, there is some suggestion that although it didn't slow the overall growth rate of geographic atrophy, and didn't have an effect on visual acuity, that perhaps it slowed the progression towards the fovea. And ultimately, when we think about treating our patients with geographic atrophy, that's the direction we really want to slow down, because we know that foveal anatomy is the most important real estate in the retina, and where the patients kind of fine central vision is located. So that was a really impactful and interesting posthoc analysis of the AREDS1 and AREDS2 studies–could just vitamins alone slow growth of GA towards the fovea.

And we said, well, let's go and look at another data set of GA patients. And can we replicate that same result? And of course, a medicine pegcetacoplan, or SYFOVRE, ran about a 1200 patient phase 3 clinical program called the OAKS and DERVY study. And about a third of those patients didn't get injections, they had sham treatment. And of course, all those patients had fellow eyes, some of whom had geographic atrophy at baseline. So here we have a relatively large population of patients who didn't receive any treatment in the OAKS and DERBY study, and we could follow them over two years. And this is with really advanced imaging, unlike AREDS, which was color fundus photography, kind of assessed on an annual basis. This was OCT and fundus autofluorescence, so really detailed reading center confirmed analyzes. And in OAKS and DERBY, about half of patients were on either AREDS1 or AREDS2. And we looked to see, does AREDS have any impact on the progression of geographic atrophy or growth towards the phobia? And the short answer is no. There is no difference between either sham or fellow eyes, so untreated population, whether they were on AREDS1 or AREDS2 or not taking any vitamin supplementation.

So in this other analysis now, also a posthoc analysis, we did not replicate the result that was seen in the AREDS1 and AREDS2 posthoc analysis. We also then looked at, well, what about in the pegcetacoplan, treated eyes? Could AREDS have any impact on those eyes. And it turns out that, again, when we look over a two year period, no difference, whether the patient was on vitamins or not in terms of pegcetacoplan,'s ability to slow geographic atrophy. Those two populations, overlap perfectly. Finally, we looked at exudative AMD, we know that the AREDS vitamins–I think, that is well established, slow or reduce the risk of developing neovascular or exudative AMD. We also know that these GA medicines, including pegcetacoplan, have an increased risk of exudative AMD development, could AREDS therapy be helpful in driving that down further, and unfortunately, we did not see any difference. So whether the patients were taking AREDS1 or AREDS2, there was really no impact on the development of Exudative AMD.

So obviously these are both the Keenan paper from AREDS1 and AREDS2, and this analysis is posthoc in nature. Lots of limitations that come with that, but we were not able to replicate that finding from AREDS1 and AREDS2. I didn't know what this–I thought would be interesting, actually, if we were able to replicate the results in the Keenan paper. Unfortunately, we weren't. I think really, what was the most interesting is really digging in on the AREDS1 and AREDS2 post hoc analysis and how frankly, confusing it is. Because in AREDS2, there was no population that didn't receive treatment. Everybody got some variation of AREDS1 plus or minus lutein and zeaxanthin or plus or minus beta carotene. So there was no real placebo or control group in AREDS2 so you sit there and scratch your head to say, well, how did they show an effect if, in that AREDS2 population, there was no control group. So I think kind of the further and deeper I got into the AREDS data, frankly, the more confusing I found it.

ARVO 2025: Analysis of AREDS oral micronutrient supplementation on geographic atrophy growth

Arshad Khanani, MD, MA FASRS discusses data from GATHER 2 Trial

Sydney M Crago, the editor of Modern Retina, talks with Arshad M Khanani, MD, MA, FASRS, about the expanded efficacy data from the GATHER 2 trial for geographic atrophy (GA).

- This transcript has been edited for clarity.

Hi, I'm Sydney Crago with modern retina and I'm here today with Dr Arshad Khanani to speak about his presentation at the upcoming meeting. He'll be talking about the 2-year expanded efficacy data of the GATHER 2 trial. Dr. Khanani, can you tell us a bit about your presentation?

Thank you, Sydney. So my talk at Angiogenesis 2024 virtual meeting is, is about the expanded efficacy of avacincaptad pegol, or ACP. As you're aware that ACP is a small pegylated RNA aptamer that is designed to be a specific inhibitor of complement C-5. Based on the 2 positive pivotal, GATHER-1 and GATHER-2 studies, ACP received FDA approval in August of last year. In my talk, I'm actually sharing the expanded efficacy data, and there are a few things [that] I wanted to highlight from my presentation. First thing, we know that ACP monthly and every other month reduce GA growth versus sham in GATHER-2. As you recall, gather to is a multicenter, international randomized study where patients receive either monthly ACP in the first year, or sham, and then they were really randomized to receive either monthly or every other month dosing while the sham group continued with the sham injection. 

So, the idea was to see if every other month can result in comparable efficacy as monthly, and that's what we saw. The other thing we notice is the treatment effect, we know that the treatment effect with ACP starts as early as 6 months. And what we saw was the treatment effect, more than doubled at over 2 years, compared to over 1 year with ACP, 2 milligram compared to sham. And then we also looked at the pooled analysis from GATHER-1 and GATHER-2. As you recall, GATHER-1 was a phase 2/3 pivotal study, and it was 18 months. So we wanted to see how pulling the data from GATHER-1 and GATHER-2 in terms of efficacy will give us more information about the treatment effect because we know that the GA is a very variable disease, and it's a multifactorial disease. So what we saw was, we saw robust efficacy of ACP in that analysis, and we saw an almost doubling of treatment effect every 6 months in the 18 months pool analysis with an overall reduction of 19% in GA growth compared to sham. Again, this is a postdoc analysis. And lastly, I presented the first time results of a match-adjusted, indirect comparative analysis or called medac analysis. And these analysis are done when level 1 evidence is missing in a head-to-head study. So we know that pegcetacoplan, which is also another drug that's approved for the treatment of GA. 

That trial enroll patients with central and non-central point involving GA, well, patients in the ACP study, in all, were enrolled with non-centerpoint involvement. So, there are different baseline characteristics of each trial, but what we can do is we can match the baseline BCVA and GA lesion growth across trials and then look at the efficacy. So, we took all the publicly available data for pegcetacoplan DERBY and OAKS study, and then we matched the parameters of bcva GA and other parameters using the data from pivotal GATHER-1 and GATHER-2 studies. And then we ended up with a population that was actually very well matched. And again, this is not level 1 evidence this is done for for payers and regulators, especially when level 1 head-to-head evidence is missing. So what we saw was, we saw greater directional doubling of treatment effect with ACP monthly compared to pegcetacoplan monthly. So I think that is something very informative for the field that if we have similar baseline characteristics, we are comparing the efficacy so we saw a reduction over 12 months of 26% with ACP, in GA growth versus sham, and we use the same in sham from the same study. So we're not comparing the sham from a different study. While we saw a 14% reduction with pegcetacoplan in the similar group. 

So we took all the data from DERBY and OAKS. And then we matched the patients from ACP in this analysis. So this was very important to find that with the match medac analysis, we saw greater benefit with ACP compared to pegcetacoplan. Of course, keeping all the caveats in mind about the limitations. 

And the other thing we looked at which matters most for our patients is vision. So we looked at visual acuity in the sham group, and the match group for ACP. And then we looked at visual acuity in Derby and oaks with every month and every other month. And we saw that ACP monthly demonstrated greater vision preservation verus a sham compared to pegcetacoplan versus sham. So when you look at the data, there is 47% greater preservation of vision compared to share with ACP. And when you look at pegcetacoplan, in the monthly group, there is 17% less vision preservation. And in the every other month group, it's 65% less vision preservation. So this was another interesting finding that patients treated with ACP had greater vision preservation, which is obviously the ultimate goal of treating these patients long term with these therapies. 

So I hope this summary of my talk was helpful to you and thank you for inviting me to share the summary of my talk.

Angiogenesis 2024: Expanded efficacy data from the GATHER 2 trial for geographic atrophy

CEO of Aviceda shares results from Phase II/III part 1 SIGLEC trail

AAO 2023: SIGLEC Trial Results

Mohammed Genead, MD, CEO of Aviceda spoke with the Ophthalmology Times team about the company's Phase II/III SIGLEC trial part 1 results, which were shared at this year's American Academy of Ophthalmology meeting.

The American Academy of Ophthalmology is holding its annual meeting in San Francisco. During the Eyecelerator event, Aviceda CEO, Mohammed Genead made a presentation on a new patient case study. Thank you for joining us today to tell us about this presentation.

Thanks so much, David, you know, for the opportunity to give more background about our clinical asset AVD-104, but before I will do that, with just quick enough background. We're Aviceda. Aviceda is a private, late clinical-stage biotech company based in Cambridge, US, we have a technology platform called HALOS, High-Affinity Ligands of Siglecs, with a lead asset AVD-104 targeting patients was GA, geographic atrophy secondary to age-related macular degeneration, and also diabetic macular edema. AVD-104, the lead asset, which we're going to give you some key data highlights today about, it's a very promising intravitreal therapy. It's a sialic acid coated nanoparticle was a dual mechanism of action. This acid was designed to modulate the over activation of critical inflammatory celluar and complement pathway, which we knew it's highly implicated in patients was GA, secondary to AMD. And the way the drug works, AVD-104 is inhibiting and repolarizing, the overly activated retina immune cells to the resolution states, as well [as] enhance the activity of complement factor H to regulate the over amplification of the alternative complement cascade.

I would love to highlight about the clinical trial. The clinical trial called SIGLEC. It's a Phase II/III ongoing, US-based clinical trial. The AVD-104 is being going after a patient was GA second to the AMD as well as the diabetic macular edema. The highlight of my presentation at the Eyecelerator at the American Academy of Ophthalmology will be focusing on the SIGLEC trial for GA. Some critical insights the dual [inaudible] of AVD-104, as I mentioned before, targets the retina inflammation by modulating the immune cell over activation through targeting the repolarization of the macrophages to the resolution state and also activating the CFH activity to normalize the complement over amplification. I'm very excited to share the part 1 of the phase II/III trial the roll is completely done. This was happening over the last, you know, few weeks. We had a press release around it, and the ongoing phase II/III part 2 is active and starting to roll patients in the next few weeks for the second randomized portion of the study. What we're going to present and we will show, we will show preliminary part 1 data, and the highlight of the data showed sustained efficacy of AVD-104. In patient with GA, for the first time, we began to see in the majority of the patients some BVCA gain, best-corrected visual acuity using the etdrs chart, and also we saw stabilization and some patient also regression in the GA lesion over time.

As I said before part 2 of the study, which will be a multicenter, double-masked randomized trial to evaluate the treatment effect of AVD-104 in patient was GA against sham and active-control is active and enrolling patient the next few weeks. [There] will be close to 219 patient and the study going to be in US. One of the key data points I want to highlight and I will present in my talk during the American Academy of Ophthalmology will be the part 1 data we have generated thus far. What I can report, and I'm very excited about it as a retina specialist physician, we didn't have we didn't see any drug-related severe adverse events, either ocular or systemic. And we didn't see any evidence of those limits associated in any patient in any cohort in part 1 of the SIGLEC Phase II/III trial. Of interest, and also we look at this very carefully, we didn't see any drug related ocular inflammation, no retinal vasculitis, or neovascularisation infection for optic nerve abnormality in any patient in any eyes in your cohort in the phase, in the part 1 of the phase II/III SIGLEC trial. Also I can report, and I will report, no patient lost 15 letters or or more best-corrected visual acuity over 3 months.


However, not the, one of the key and and also the early efficacy data we have generated showed up to 80% in the majority of the patients analyzed thus far have reported best-corrected visual acuity gain after a single injection with AVD-104. And this was very clear dose response with the higher the dose, the more gain you see in these patients. Also initial data on the GA lesion hyper autofluorescence area, which was graded by a masked third party greater reading center, suggests stabilization and/or regression of the leading edge of the GA lesion.


So, in summary, we're very excited about the safety profile of AVD-104 in the clinic, that patient is, the drug looks very well-tolerated and safe at this moment was this early efficacy data is shown for the first time in GA space BCVA gain in patient was GA secondary MD and stabilization of the GA lesion is quite exciting, and we're very intrigued. And we're going to continue the development to the part 2, which is actively enrolling right now. And we will report more data in the upcoming clinical meetings or medical conferences in the next few weeks and the beginning of 2024.

AAO 2023: AVD-104 and the results of the phase II/III part 1 SIGLEC trial

Our team spoke with several researchers and industry professionals at the 2023 American Society of Retina Specialists meeting in Seattle, Washington. We asked them, "What research here do you find exciting or interesting?" Here's what Paul Hahn, MD, PhD, Kerrie Brady, BPharm, MBA, MS, and Michael Singer, MD had to say!

You know, one of the best things about these meetings is that you get, you get to learn about different things that are coming. And, you know, we hear about different mechanisms of treatment for geographic atrophy, different mechanisms of treatment for wet AMD, different methods of delivery, gene therapy, and so forth. And, you know, it's really learning more about these at these types of meetings really, what's, what's innovative.

Yes, we're particularly excited about the growth and expansion of AI and machine learning to enable diagnosis. And so with that, with the machines getting smaller, getting more into the community, we are looking forward to being able to detect more patients at earliest stages in their disease. And with a product such as OTT-166, begin early active treatment sooner in their disease process.

I am excited about the possibility and when I looked at patients who were being treated in a high dose Eylea trial, that you're able to get a significant number of patients, 44%, to essentially go 20 or 24 weeks. Even though it's a clinical trial, I think it really potentially has real ramifications to our patients in practice.

We asked, "What research at ASRS 2023 do you find exciting or interesting?" Here's what Paul Hahn, MD, PhD, Kerrie Brady, BPharm, MBA, MS, and Michael Singer, MD had to say!

ASRS 2023: Attendees share most interesting topics from annual meeting

Carl Regillo, MD, FACS, FASRS, spoke with our team following the annual ASRS meeting in Seattle, Washington to share insights from his presentation titled, "Modulation of Macrophages and Complement Dysfunction in Non-exudative AMD utilizing novel, sialic-acid coated nanoparticles."

I'm David Hutton of Ophthalmology Times. The American Society of Retina Specialists is hosting its annual scientific meeting this year in Seattle. Joining me is Dr Carl Regillo to talk about his presentation at this year's conference. Thank you so much for joining us. Tell us a little bit about your presentation.

Thanks, David. [I'm] happy to be part of this. My presentation titled, "Modulation of Macrophages and Complement Dysfunction in Non-exudative AMD utilizing novel, sialic-acid coated nanoparticles." Now, that's a lot. So [it] really describes a new mechanism of action of a therapeutic that's now in clinical trials for the treatment of geographic atrophy from AMD, in particular. 

So, what does all this mean? Well, we know that complement intubation has shown a reduction in GA lesion growth rates. We also know that the C3 C5 blockers that have been successful through Phase 3 trials have shown efficacy that have been rather modest. Plus, there's the side effect of secondary corneal neovascularization, which does appear to be a class effect. With a modest or limited degree of efficacy, it points to the fact that there's got to be another mechanism that is driving geographic atrophy. And indeed, there is evidence to suggest that the cellular arm of the innate immune response, namely macrophages, activated macrophages, play a role. 

So, there is evidence to show. Just like we're familiar with the deposition, or abnormal deposition, of complement in and around [inaudible] geographic atrophy and histopathologic studies. These studies also show an increased amount of macrophages, and there have been labeling experiments that show that these are actually pathologic or activated, so called activated macrophages. Macrophages exist in several forms, pathologic types, M1 [and] M2 for example, and then there's resolution resting or non pathologic types. 

Carl Regillo, MD, FACS, FASRS, spoke with our team following the annual ASRS meeting in Seattle, Washington to share insights from his presentation titled, "Modulation of Macrophages and Complement Dysfunction in Non-exudative AMD utilizing novel, sialic-acid coated nanoparticles." Aviceda Therapeutics is unlocking the proteogenomic code of AMD to target proteins and pathways linked to macular degeneration.  

Geographic Atrophy

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