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The plan is intended to upgrade Vitagrus’ manufacturing process so that it can ultimately handle the global market supply.

ABVC BioPharma announces approved plan for pilot Good Manufacturing Practice (GMP) facility to produce Vitargus

THR-149 is being evaluated in a Phase 2 clinical trial as a potential treatment for diabetic macular edema, which is expected to readout topline results by the end of this year.

Oxurion receives upfront payment of approximately $400,000, contributing to Oxurion’s investment in THR-149

Belite Bio has completed patient enrollment for a trial evaluating Tinlarebant, which is the first ever treatment for Stargardt Disease.

Belite Bio concluded enrollment in Pivotal Global Phase 3 DRAGON Trial

Clearside Biomedical developing a long-acting therapy for the treatment of retinal diseases, including wet AMD.

Clearside Biomedical starts enrollment of participants in its ODYSSEY Phase 2b clinical trial of CLS-AX

A new study titled, “Prevalence of Diabetic Retinopathy in the US in 2021,” finds that almost 10 million people in the United States with diabetes have diabetic retinopathy.

New study finds estimated 9.6 million people in the US have DR and 1.84 million people have VTDR

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

Two FDA-approved geographic atrophy treatments show significant patient dropout, with 45% discontinuation by 18 months, driven by baseline vision, CNV, and lack of immediate visual improvement.

Geographic Atrophy Treatment: High Attrition Rates Challenge Long-Term Patient Compliance

 treatment, Deepak Sambhara, MD, from the Eye Clinic of Wisconsin analyzed long-term patient compliance with two recently FDA-approved complement inhibitor therapies: pegcetacoplan (peg) and avacincaptad pegol (ACP).

The retrospective multicenter database review, using Vestrum Health data, examined 20,000 eyes from 15,000 patients. Key findings revealed significant treatment attrition rates, with 25% of patients discontinuing within six months and nearly 45% dropping out by 18 months.

Baseline patient characteristics showed complex challenges: approximately one-third of eyes had study eye choroidal neovascularization (CNV), 40% had fellow eye CNV, and over 50% experienced subfoveal involvement. Average visual acuity was around 55 ETDRS letters (20/80 vision).

Three primary risk factors predicted treatment discontinuation: study eye CNV, fellow eye CNV, and extremely poor vision (20 letters or less on ETDRS). The research highlighted the unique challenges of GA treatment, where patients do not experience immediate visual improvement unlike anti-VEGF treatments.

Market dynamics also influenced treatment patterns, with fewer new starts correlating with events like the ASRS ReST committee's position statement and potential third-party payer access issues.

Sambhara emphasized the need to create a "culture of compliance" for GA patients, recognizing that traditional motivation strategies are ineffective in a progressive disease context. The study underscores the importance of longitudinal monitoring and developing innovative approaches to maintain patient engagement in long-term treatment.

"In some respects, large database studies can make informed decisions for how we understand trends that we may not be realizing on the individual practice level, but if we see these global trends start to emerge, it helps us identify where gaps exist and how we can potentially bridge those gaps," Sambhara said. "And so for every problem that exists, it's actually an opportunity that's created. In the world of geographic atrophy, it's difficult because we don't have instant gratification. The best revision is ever going to be is today, because it's a continually progressive disease."

This research provides crucial insights into real-world treatment challenges and opportunities for improving patient care in geographic atrophy management.

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Geographic atrophy treatment: High attrition rates challenge long-term patient adherence

W. L. Gore and associates (Gore) announced the launch of its silicone-free GORE IMPROJECT Plunger for 0.5-mL pre-filled syringes that are designed specifically to facilitate the delivery of ophthalmic drugs. According to a company press release, the 0.5-mL prefilled syringe product addresses particle and silicone sensitive applications and is targeting ophthalmic/retinal and to a lesser degree, gene therapy applications.

The applications of the plunger, the use of which also includes ophthalmic intravitreal injections, complements theGORE IMPROJECT 1-mLL plunger launched in mid-2018.

This new product is in contrast to conventional pre-filled syringe systems that use silicone to provide a seal and act as a lubricant between the barrel and the plunger. Complications of products that include silicone in their manufacturing process have been reported in the literature and include elevated subvisible particulate levels, silicone accumulation in the eye resulting in floaters, silicone-induced protein aggregation resulting in immunologic responses, and ocular inflammation and elevated intraocular pressure. Syringes that contain silicone also have been associated with increases in particle counts and fatty acid creation over time.

The company claims that the new plunger enables syringe systems to achieve particulate levels below the limits of the United States Pharmacopeia 789 subvisible particle standard.The plunger can be terminally sterilized and has been shown to provide suitable break loose and glide force and container closure integrity performance when used with appropriate syringe components and commercial fill and finish processes.

Gore Syringe Business Leader, Emily Oliver commented, “Gore’s 0.5-mL plunger, in combination with a silicone-free glass or advanced polymer syringe barrel, enables pharmaceutical companies to achieve what they’ve been asking for, ie, to reduce the risk associated with silicone by enabling its removal from the syringe plunger and barrel.”

Development of this new product was achieved by close collaboration with pharma companies, chief marketing officers, terminal sterilization companies, machine companies that design equipment for fill operations, and leading syringe barrel suppliers. “We involved key partners to ensure the product meets the needs of stakeholders throughout the value chain including rigorous fill and finish requirements. This is a breakthrough solution for the industry and was designed with the goal of improving patients’ lives,”according to Russ Hornung, Gore Business DevelopmentManager.

Gore recently launched its silicone-free GORE IMPROJECT Plunger for 0.5-mL pre-filled syringes for the delivery of ophthalmic drugs.

Silicone-free plunger for ophthalmic drug delivery

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."

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

Heidelberg Engineering announced its 2025 International SPECTRALIS Symposium (ISS) will be held in Heidelberg, Germany, from 13 to 14 June. This year marks the 21st anniversary of the ISS, and the event will be the first ISS held in the newly-opened Heidelberg Congress Center, the company said in a press release.

 The keynote presentation will be given by Warren Hoburg and Tyson Brunstetter, OD, PhD, astronauts at the US-based National Aeronautics and Space Administration.

Frank Holz, MD, FEBO, FARVO, professor and chair of the Department of Ophthalmology at University of Bonn, Germany, will serve as chair for the symposium. Over the course of 2 days, attendees will be able to hear from 35 different speakers, traveling to Heidelberg from across 12 countries.

“What began 21 years ago as a dedicated retinal imaging event has evolved into a comprehensive platform for innovation in ophthalmology,” Holz said in the press release. “The opportunity to engage with such a distinguished group of experts and discuss emerging therapies in this setting is truly unparalleled.

 includes 7 different sessions over the course of the symposium, with multiple lectures on each topic: oculomics, high-resolution optical coherence tomography (OCT), new technology, 

, artificial intelligence, retina and distributed care. The keynote session on Friday, 13 June will be presented in conjunction with NASA and is titled "A journey into space."

Researchers use Heidelberg's Spectralis OCT technology onboard the International Space Station to investigate the effects of microgravity environments on vision. NASA began using the technology in 2013, and in 2019, a second Spectralis device equipped with the OCT2 Module was installed on the space station.

 The collaborative research focuses in part on Space Flight Associated Neuro-Ocular Syndrome (SANS), a condition that which commonly causes unilateral and bilateral optic disc edema in patients who have spent time in microgravity environments.

“Every day at NASA we learn something new about the impact of space travel on the human body, and ocular health in particular," said Hoburg ahead of the meeting. "I am honored to be on this stage with Brunstetter and look forward to sharing our insights, learnings, and experiences with this year’s symposium attendees."

Along with live scientific sessions, attendees will be able to visit the exhibition hall or take a tour of the SkyLabs Tower, Heidelberg Engineering's company headquarters.

The exhibition hall will feature a showcase of the SeeLuma digital microscope with intraoperative OCT. Following the conclusion of the scientific program on Friday evening, Heidelberg Engineering will host a boat cruise dinner reception on the river Neckar.

The full scientific program can be found 

International SPECTRALIS Symposium – AND BEYOND. Press release. Heidelberg Engineering. Published March 7, 2025. Accessed March 7, 2025.

NASA Astronauts Warren Hoburg and Tyson Brunstetter to Headline Heidelberg Engineering’s 2025 International SPECTRALIS Symposium. Press release. Heidelberg Engineering. Published May 22, 2025. Accessed May 22, 2025.

International SPECTRALIS Symposium and Beyond: Our Best Program. Heidelberg Engineering Academy. Accessed March 7, 2025. 

https://www.academy.heidelbergengineering.com/hedata/e-learning/Totara/Dateien/ScientificProgram_ISS2025_Heidelberg.pdf

Join global experts at the 2025 International SPECTRALIS Symposium in Heidelberg, exploring innovations in ophthalmology and space-related ocular health.

Canonical

NASA astronauts to keynote 2025 International SPECTRALIS Symposium in Heidelberg

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.

Marlissa Miller

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