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Despite setbacks in DME, Adverum Biotechnologies said it will continue to develop ADVM-022 for wet AMD.

Serious adverse reaction halts gene therapy for diabetic macular edema

Retina World Congress 2025 will take place May 8-11. As researchers prepare for their, presentation, we are highlighting the upcoming sessions that are scheduled for this meeting, which will be held in Fort Lauderdale, Florida.

Note: The following list of presentations are in alphabetical order by company. Updates will be added to this article as new information becomes available.

The company highlight Phase 2 results for migaldendranib (MGB), Ashvattha’s investigational subcutaneous treatment for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). The presentation, entitled, "Emerging Data om Anti-angiogenic Nanomedicine (Migaldendranib MGB/D-4517.2) for AMD and DME" will be given by Michael Singer, MD on Sunday, May 11, 2025; 11:11 – 11:16 am ET.

Phase 2 clinical data demonstrated that MGB administration lowered production of subretinal fluid reducing or eliminating the need for intravitreal anti-VEGF treatment in both the study eye and fellow eye in wet AMD and DME subjects with bilateral disease. New data indicates that MGB may be the first safe systemic therapy for the treatment of wet AMD and DME without ocular adverse events.

Huma Qamar, Chief Medical Officer at Ocugen will represent Ocugen at Retina World Congress to share a presentation and join retinal surgeons and industry peers during a panel discussion.

Inherited and Rare Retinal Diseases Session
Moderated by Rishi P. Singh, MD, FASRS and Kourous A. Rezaei, MD on Thursday, May 8, 2025, 10:35 – 11:12 AM ET

Ocular Therapeutix will present information at the meeting in Fort Lauderdale regarding the axitinib intravitreal hydrogel clinical trials, the use of its candidate OTX-TKI for diabetic retinopathy, and the HELIOS clinical trial for diabetic retinopathy.

Axitinib Intravitreal Hydrogel: Update on Clinical Trials

Presented by Carl C. Awh, MD, FASRS, on Friday, May 9, 2025, 4:33 – 4:38 PM ET.

Presented by Dilsher S. Dhoot, MD, FASRS on Saturday, May 10, 2025, 8:44 – 8:49 AM ET

Volumetric Macular Fluid Analysis of the Impact of a Single Axitinib Intravitreal Injection (OTX-TKI) from the HELIOS Clinical Trial for Diabetic Retinopathy

Presented by Carl J. Danzig, MD on Saturday, May 10, 2025, 8:52 – 8:57 AM ET

The company will present further insights from Stage 1 of the Phase 3 DIAMOND program reinforcing the efficacy and safety profile of OCS-01 eye drops for DME will also be shared. OCS-01 is being developed to be the first non-invasive treatment for DME, addressing key unmet needs for earlier treatment intervention and for inadequate responders to the current standard of care.

Ashvattha Therapeutics to Present at ARVO, Retina World Congress, and AOS Annual Meeting. Ashvattha Therapeutics. April 15, 2025. Accessed April 16, 2025. https://www.globenewswire.com/news-release/2025/04/15/3061682/0/en/Ashvattha-Therapeutics-to-Present-at-ARVO-Retina-World-Congress-and-AOS-Annual-Meeting.html

Ocugen to Present on Modifier Gene Therapy Platform at Association for Research in Vision and Ophthalmology 2025 Annual Meeting and Retina World Congress. Ocugen Inc. April 29, 2025. Accessed April 30, 2025. https://www.globenewswire.com/news-release/2025/04/29/3070074/0/en/Ocugen-to-Present-on-Modifier-Gene-Therapy-Platform-at-Association-for-Research-in-Vision-and-Ophthalmology-2025-Annual-Meeting-and-Retina-World-Congress.html

Ocular Therapeutix™ to Participate in Upcoming Investor and Scientific Conferences. Ocular Therapeutix. April 29, 2025. Accessed April 29, 2025. https://www.globenewswire.com/news-release/2025/04/29/3070022/0/en/Ocular-Therapeutix-to-Participate-in-Upcoming-Investor-and-Scientific-Conferences.html

Oculis to Present its Innovative Late-Stage Pipeline Candidates at Upcoming Ophthalmology Conferences. Oculis Holding AG. May 1, 2025. Accessed May 1, 2025. https://www.biospace.com/press-releases/oculis-to-present-its-innovative-late-stage-pipeline-candidates-at-upcoming-ophthalmology-conferences

Companies working in the retina space have announced that data from clinical trials will be shared at this year’s meeting in Fort Lauderdale, Florida.

RWC 2025: Companies to share data at meeting in Fort Lauderdale

Breye Therapeutics announced the successful completion of its phase 1b clinical trial of an oral therapy, danegaptide, for early treatment of non-proliferative 

Danegaptide is a first-in-class oral small molecule with a novel mode of action that stabilizes the vasculature and protects against cell-cell uncoupling, retinal capillary breakdown, and vascular leakage caused by hyperglycemia, according to the company.

The drug has the potential to fill a treatment gap for these patients. While successful intravitreally administered products have been developed for patients with late-stage disease, treatment options are currently limited for patients in the earlier or moderate stages. The intravitreal treatments are burdensome, often poorly tolerated, and associated with low compliance, highlighting the critical need for effective and non-invasive alternatives, according to the press release.

The Phase 1b trial was a multicenter, open-label, dose-escalation study that assessed the safety, tolerability, pharmacokinetics, and early signs of biologic activity of danegaptide in patients with NPDR and associated diabetic macular edema. The study was performed in 11 clinical sites in the UK, Germany, and the US and enrolled 24 patients.

According to a company press release, the first-in-class oral treatment demonstrated that

The oral treatment was well tolerated, with early signs of clinical activity

In models of NPDR, danegaptide has demonstrated protection against retinal capillary loss and vascular leakage

Data support continued advancement into Phase 2 clinical evaluation

No dose-limiting toxicities were reported. The pharmacokinetic data confirmed that targeted exposures of danegaptide were reached as guided by preclinical data. Early signs of clinical activity were observed on retinal imaging, with reductions in retinal vascular leakage and improvements in anatomic parameters observed.

“An oral approach like danegaptide has the potential to fundamentally shift how we treat moderate-to-severe stages of diabetic eye disease, offering patients a much-needed and non-invasive treatment solution for the large group of patients with NPDR,” said Carl Regillo, MD, Director of Retina Service of Wills Eye Hospital, Professor of Ophthalmology at Thomas Jefferson University in Philadelphia, and a member of the Breye Therapeutics Scientific Advisory Board.

“These results continue to support danegaptide’s potential as an oral, non-invasive therapeutic solution for patients in the earlier stages of diabetic retinopathy. As we now prepare to advance into Phase 2 clinical evaluation, our focus is on validating these findings using regulatory-accepted clinical outcomes to progress our mission of developing safe and effective treatment options for these patients to preserve their vision before the onset of irreversible damage. Additionally, we believe this treatment solution may also support the maintenance of treatment response after induction therapy with intravitreally administered products,” according to Ulrik Mouritzen, Chief Executive Officer of Breye Therapeutics.

A subsequent Phase 2 trial is planned to evaluate danegaptide in a targeted NPDR patient population using the regulatory endpoint of ≥2-step improvement on the Diabetic Retinopathy Severity Scale.

Breye Therapeutics advances danegaptide, a novel oral therapy for non-proliferative diabetic retinopathy, showing promise in early clinical trials.

clinical

Successful phase 1B study of oral therapy for diabetic retinopathy

Formycon AG announced that the Brazilian Agência Nacional de Vigilância Sanitária (ANVISA) has granted marketing authorisation for FYB201 (Ranivisio), a biosimilar to Lucentis (ranibizumab, Genentech Inc.). FYB201 was developed by Bioeq AG, a joint venture between Formycon AG and Polpharma Biologics Group BV.

Along with the regulatory decision, Formycon announced it has established a commercialization partnership with the Brazilian pharmaceutical company Biomm. The company focuses on the development, manufacturing and distribution of biopharmaceutical drugs, including biosimilars.

Biomm's product launch of FYB201 is expected to occur in the fourth quarter of 2025, marking the beginning of a phased market rollout of FYB201 across Latin America. The regional regulatory authorities in Peru, El Salvador, Honduras and the Dominican Republic have already granted marketing authorizations for the biologic drug. Further approvals and product launches in Central and South America are planned through early 2027, according to the press release issued by Formycon.

Formycon Chief Business Officer Nicola Mikulcik stated, "The marketing approval of FYB201/Ranivisio in Brazil underlines our mission to improve access to high-quality biologic drug therapies, especially in countries where the use of high-cost biologics is quite limited today. We are extremely pleased to offer a safe, effective and affordable treatment option for the growing patient population with severe retinal diseases in Brazil.”

FYB201 is used to treat severe visual impairments such as wet age-related macular degeneration and other retinopathies. The biosimilar is currently available in a total of 21 countries in Europe, North America, the Middle East and North Africa.

1. Lucentis® biosimilar FYB201/Ranivisio® (ranibizumab) approved in Brazil. Press release. Formycon AG. Published June 5, 2025. Accessed June 5, 2025. https://www.formycon.com/blog/press-release/lucentis-biosimilar-fyb201-ranivisio-ranibizumab-in-brasilien-zugelassen/

Brazilian regulatory authority ANVISA grants marketing authorization for Ranivisio.

Canonical

Brazil’s ANVISA grants marketing authorization to Lucentis biosimilar FYB201 (Ranivisio, Formycon/Bioeq AG)

Dilsher S. Dhoot, MD, discusses how second-generation anti-VEGF agents like aflibercept 8 mg and faricimab demonstrate significant efficacy in treating diabetic macular edema (DME), allowing for extended treatment intervals of 9 to 10 weeks compared to monthly dosing with earlier agents, while improving anatomic outcomes and visual acuity.

Rapid Improvements In DME With Next-Generation Anti-VEGF Therapies: Case Highlights

The second episode transitions to diabetic macular edema (DME) treatment using next-generation anti-VEGF agents. Dr. Dhoot presented a case with large cystoid changes and intraretinal fluid that showed progressive improvement after aflibercept 8 mg treatment. Although the initial response after the first injection wasn’t dramatic, continued improvement was observed with subsequent treatments, highlighting the importance of patience when evaluating treatment efficacy.

Another DME case demonstrated limited response to aflibercept 2 mg but showed significant anatomical improvement and vision enhancement from 20/60 to 20/25 after switching to aflibercept 8 mg. The panel noted that the higher molar dose (4x) of aflibercept 8 mg appeared to produce consistently better anatomic responses in DME patients, a finding commonly observed across their practices. This reinforces the value of higher-dose anti-VEGF options for patients with suboptimal responses to standard dosing.

Dr Dhoot shared a personal case of a 72-year-old man with DME who initially received a ranibizumab biosimilar with limited durability, requiring monthly dosing. After switching to faricimab, the patient showed dramatic improvement with treatment intervals successfully extended to 9 weeks. The case illustrated the importance of finding each patient’s “sweet spot” for treatment intervals, as attempts to extend beyond 9 to 10 weeks resulted in fluid recurrence. In summary, newer-generation anti-VEGF agents provide improved drying efficacy and typically allow 2- to 3-week treatment extensions, significantly reducing treatment burden while improving outcomes.

Dilsher S. Dhoot, MD, discusses how newer anti-VEGF treatments, particularly aflibercept 8 mg, can provide improved anatomic outcomes and extended treatment intervals for patients with neovascular age-related macular degeneration who show persistent subretinal fluid despite treatment with first-generation agents.

Improved Retinal Drying and Treatment Durability In nAMD With Aflibercept 8 mg

Video content above is prompted by the following: 

The first episode discusses case-based roundtable findings from retina specialists and residents regarding neovascular age-related macular degeneration (nAMD) treatment. Dilsher S. Dhoot, MD,

from California Retina Consultants, presents multiple cases showing the efficacy of second-generation anti-VEGF therapies. The first case highlights a patient with persistent subretinal fluid despite bevacizumab treatment who showed improvement after switching to aflibercept 8 mg, demonstrating both improved durability and efficacy with treatment intervals extending to 8 weeks.

A second case presents a patient with bilateral nAMD and pigment epithelial detachments (PEDs) who responded exceptionally well to aflibercept 8 mg in both eyes, achieving near-resolution of PEDs and complete resolution of intraretinal fluid. The panel discussed different treatment approaches, with some physicians preferring three loading doses before extension while others treated to dryness before immediately extending treatment intervals. The importance of discussing retinal pigment epithelial tear risks with patients having large PEDs was emphasized.

Additional cases demonstrated aflibercept 8 mg’s effectiveness in patients with suboptimal responses to first-generation therapies. One patient with a fibrous PED and subretinal fluid showed marked improvement after switching from bevacizumab to aflibercept 8 mg, with vision improving from 20/100 to 20/50. The final case illustrated that while some patients respond well to first-generation therapies like aflibercept 2 mg, careful monitoring is necessary as durability may be limited, with reactivation of subretinal fluid requiring consistent treatment.

Video Series

Ocugen has announced the signing of a binding term sheet to negotiate and enter into a licensing agreement with a “well-established leader in the pharmaceutical and healthcare sector in Korea” for exclusive Korean rights to OCU400.

OCU400 is Ocugen’s novel modifier gene therapy for retinitis pigmentosa (RP). The OCU400 (AAV5-h

) gene therapy platform delivers the nuclear hormone receptor 

 to the retina and retinal pigment epithelium (RPE) to preserve and potentially restore retinal structure and function.

Under the license agreement, Ocugen will receive upfront license fees and near-term development milestones up to $11 million. Ocugen will be entitled to sales milestones of $1 million for every $15 million of net sales in Korea, in addition to a royalty of 25% on net sales of OCU400 generated by the unnamed partner. Manufacturing of OCU400 will be conducted by Ocugen.

According to a press release from the company, there are an estimated 15,000 individuals in the Republic of Korea with RP.

Shankar Musunuri, PhD, MBA, chairman, CEO, and co-founder of Ocugen, commented on the agreement in a press release from the company, saying, “This regional licensing agreement is aligned with our business development strategy to partner with well-established companies in their respective countries and regions—leveraging their networks and know-how to treat as many RP patients as possible.”

Ocugen noted that additional details of the deal will be available when the definitive agreement between the parties is executed, which is expected to happen within the next 60 days.

announced a positive 2-year safety and efficacy update

 for the phase 1/2 OCU400 clinical trial for the treatment of early to advanced RP in pediatric and adult populations. According to the company, OCU400 demonstrated meaningful improvement of 2-line gain (10 letters on ETDRS chart) in low-luminance visual acuity (LLVA) in treated eyes when compared to untreated fellow eyes.

Ocugen is currently advancing OCU400 through phase 3 clinical development (liMeliGhT) with a target Biologics License Application filing in mid-2026.

Ocugen, Inc. announces signing of binding term sheet for the license of OCU400 modifier gene therapy for retinitis pigmentosa in Korea. Published June 5, 2025. Accessed June 5, 2025. 

https://www.globenewswire.com/news-release/2025/06/05/3094247/0/en/Ocugen-Inc-Announces-Signing-of-Binding-Term-Sheet-for-the-License-of-OCU400-Modifier-Gene-Therapy-for-Retinitis-Pigmentosa-in-Korea.html

Crago S. Ocugen announces positive 2-year safety and efficacy update of Phase 1/2 OCU400 for treatment of retinitis pigmentosa. Published January 15, 2025. Accessed June 5, 2025. https://www.ophthalmologytimes.com/view/ocugen-announces-positive-2-year-safety-and-efficacy-update-of-phase-1-2-ocu400-for-treatment-of-retinitis-pigmentosa


OCU400 is Ocugen’s novel modifier gene therapy for retinitis pigmentosa (RP).

Victoria Johnson

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