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Minimizing clinic visits, maximizing use of imaging modalities are key

Adapting medical retina service in COVID-19 era requires careful approach

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

Boehringer Ingelheim recently announced the start of the THULITE phase 2 clinical study (

). THULITE will evaluate the efficacy, safety, and tolerability of BI 1815368, an oral medication for the treatment of 

Affecting more than 21 million people globally, DME is a leading cause of vision loss in people with diabetes. Current treatments for DME are limited, requiring frequent visits to a retina specialist for eye injections, and only addressing 1 eye at each visit.

“An oral therapy for DME could represent a major step forward in its management,” said Charles C. Wykoff, MD, PhD, principal investigator of the trial, director of research for Retina Consultants of Texas, and chair of research for Retina Consultants of America.

"A safe and effective systemic therapy would offer an important alternative to repeated intravitreal injections; it could enable more consistent initiation of care earlier in the disease process, improve treatment adherence, and optimize quality of life for patients."

This oral therapy would aim to prevent fluid leakage into the macula caused by DME by reducing the permeability of newly formed blood vessels. Through oral administration, unlike current treatments, BI 1815368 would allow for the potential of at-home treatment, while simultaneously addressing both eyes.

“DME is one of the most challenging complications of diabetes, and as vision worsens, people may lose their independence and rely more on loved ones,” said Dario Madani, CEO at PRO RETINA, members of which serve on Boehringer’s DME Clinical Program Steering Committee.

“Patients and caregivers may have to balance work, family obligations, and other diabetes complications, while managing their eye condition. We need treatment options that could reduce this burden.”

Part of Boehringer’s broader clinical program targeting diabetic retinal disease, BI 1815368 is the fourth investigational compound from Boehringer Ingelheim’s Eye Health portfolio to advance to a phase 2 clinical trial, a press release said. The broader program also includes BI 764524, which is currently being studied in the CRIMSON phase II trial (

“At Boehringer Ingelheim, we are working toward a future where earlier intervention leads to long-term outcomes that prevent vision loss. One way we aim to achieve this is by developing oral treatments, which offer patients the ability to be more in control of their condition,” said Patrick Bussfeld, MD, PhD, global head of medicine, eye health at Boehringer Ingelheim.

“By targeting the disease pathway systemically, we also have the potential to prevent DME in one eye while the other is being treated.”

Boehringer-ingelheim.com. Published 2025. Accessed July 7, 2025. 

https://www.boehringer-ingelheim.com/science-innovation/human-health-innovation/phase-ii-start-oral-treatment-diabetic-macular-edema

Boehringer Ingelheim initiates THULITE study, exploring an oral treatment for diabetic macular edema, aimed to improve patient care and convenience.

clinical

THULITE phase II study evaluates BI 1815368

Opus Genetics, Inc, announced that the company entered into an agreement with the Retinal Degeneration Fund (RD Fund), the venture philanthropy arm of the Foundation Fighting Blindness, through which Opus will receive up to $2 million in nondilutive funding to support the advancement of Opus’s OPGx-MERTK program. Through this program, gene therapies are developed to treat patients with retinitis pigmentosa caused by pathogenic variants in the 

George Magrath, MD, who is CEO of Opus Genetics, said, “This strategic funding enables us to advance the development of OPGx-MERTK, a promising program that aims to address a retinal degenerative condition with no currently approved therapies. OPGx-MERTK is currently in preclinical development, and we expect this financial support will allow us to move this asset toward Investigational New Drug enabling studies. We are grateful to the Foundation Fighting Blindness and the RD Fund for their continued partnership as we work to bring meaningful treatments to patients suffering from vision-threatening conditions.”

 gene cause a rod-cone dystrophy with early macular atrophy, with retinitis pigmentosa being the most common phenotype. Opus is developing OPGx-MERTK as a modern adeno-associated virus vector for the treatment of MERTK-associated inherited retinal disease, which affects approximately 600 individuals in the US.

This investment reflects the power of combining venture philanthropy, industry collaboration, and cutting-edge science to deliver meaningful progress for patients. Rusty Kelley, PhD, managing director of the RD Fund, commented, “Our alliance with Opus Genetics leverages the full strength of the Foundation Fighting Blindness community—our donors, mission, and team—alongside the proven expertise of Opus and gene therapy pioneers Drs Jean Bennett and Tomas Aleman, to accelerate life-changing treatments.”

With the addition of this funding, based on current projections, Opus believes that its cash on hand will now be sufficient to fund operations into the second half of 2026.

Through the program, gene therapies are developed to treat patients with retinitis pigmentosa caused by pathogenic variants in the MERTK gene.

Canonical

Retinal Degeneration Fund providing funding to Opus Genetics to support OPGx-MERTK program

Belite Bio, Inc, has completed enrollment in the PHOENIX trial. The PHOENIX study is a 24-month, randomized, double-masked, placebo-controlled, multicenter, pivotal phase 3 trial for this oral medication. This trial will evaluate the safety and tolerability of tinlarebant and its potential to reduce atrophic lesion growth rate in patients diagnosed with geographic atrophy (GA) in dry age-related macular degeneration (AMD).

The study is ongoing across sites in the United States, the United Kingdom, France, the Czech Republic, Switzerland, China, Taiwan, and Australia.

Dr Tom Lin, chairman and CEO of Belite Bio, is quoted in the company’s press release

 on this news, saying, “Completing enrollment in the PHOENIX trial marks an important milestone for Belite Bio as we advance our lead candidate, tinlarebant, for the treatment of geographic atrophy. This achievement brings us one step closer to evaluating the potential of tinlarebant to slow atrophic lesion growth in this serious and progressive disease for which there are no approved oral treatments. There remains a significant unmet need for this patient population. We remain committed to advancing tinlarebant through late-stage development and look forward to sharing interim results at the midpoint of the PHOENIX trial.”

Similarly, Dr Hendrik Scholl, chief medical officer of Belite Bio, also celebrated the global aspect of this trial and the potential it has to advance GA treatment options. He said, “We are pleased to announce the completion of enrollment in our pivotal clinical trial in geographic atrophy, a milestone that reflects strong global interest in our investigational therapy. The United States led enrollment by a significant margin, underscoring the appeal of a convenient, once-daily oral tablet compared to existing invasive treatment options.”

“Geographic atrophy is a progressive and debilitating condition that can severely impact a person’s vision and therefore quality of life, yet treatment options remain limited,” said Dr. David Rhee, principal Investigator at one of the top recruiting sites for the PHOENIX trial. “The PHOENIX study is designed to evaluate the efficacy of tinlarebant in slowing the growth of atrophic lesions, a key clinical marker of disease progression. Completing enrollment is a meaningful step in advancing research for this patient population, and I look forward to seeing the results from this important study.”

 reported on the DRAGON trial, including that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation for the company’s treatment for Stargardt disease (STDG1), tinlarebant.

Tinlarebant is an orally administered, once-a-day tablet intended as an early intervention for maintaining the health and integrity of retinal tissues in patients with Stargardt disease type 1 (STGD1) and Geographic Atrophy (GA). Currently, there are no FDA-approved treatments for STGD1 and no approved orally administered treatments for GA. Therefore, if approved, tinlarebant would be a novel oral therapeutic addressing an unmet medical need in both STGD1 and GA. Tinlarebant has been granted rare pediatric disease designation, fast track designation, and breakthrough therapy designation in the United States as well as orphan drug designation in the United States, Europe, and Japan. It has also received Sakigake (pioneer drug) designation in Japan for STGD1.

Belite Bio Announces Completion of Enrollment in the Pivotal Global Phase 3 PHOENIX Trial Evaluating Oral Tinlarebant in Geographic Atrophy. Belite Bio, Inc. July 2, 2025. Accessed July 7, 2025. 

https://investors.belitebio.com/news-releases/news-release-details/belite-bio-announces-completion-enrollment-pivotal-global-phase

Filkins K. FDA grants Breakthrough Therapy Designation for Tinlarebant. Ophthalmology Times. May 21, 2025. Accessed July 7, 2025. https://www.ophthalmologytimes.com/view/fda-grants-breakthrough-therapy-designation-for-tinlarebant

Belite Bio completes enrollment in the pivotal PHOENIX trial, advancing tinlarebant's potential to treat geographic atrophy.

Phase 3 PHOENIX trial for oral GA treatment completes enrollment

Beacon Therapeutics has completed enrollment in its registrational phase 2/3 VISTA trial evaluating laru-zova for the treatment of X-linked retinitis pigmentosa (XLRP).

) is a randomized, controlled, masked, multicenter study evaluating and comparing 2 dose levels of laru-zova with an untreated control group. A single subretinal injection of laru-zova dose 1 or dose 2 will be administered in patients in 2 treatment groups, whereas patients in the untreated control group will be followed and evaluated, after which they will be evaluated to determine whether they are eligible to receive treatment with dose 2 of laru-zova. Patients will be evaluated by the improvement in low-luminance visual acuity (LLVA) and mean sensitivity as observed by microperimetry, among other measures of visual function.

The trial enrolled approximately 75 male patients aged 12 to 50 years with X-linked retinitis pigmentosa caused by RPGR mutations, across sites in North America, the United Kingdom, and Australia. Those enrolled will be randomized 1:1:1.

The company noted that it plans to use the data from the VISTA trial, alongside long-term data from the ongoing Phase 2 DAWN trial and the Phase 1/2 HORIZON and Phase 2 SKYLINE studies, to support regulatory submissions in the United States and Europe.

Lance Baldo, MD, CEO of Beacon Therapeutics, and Daniel Chung, DO, MA, CMO of Beacon Therapeutics, commented on the trial in a press release from the company.

“Completion of enrollment in our VISTA trial marks a significant milestone for Beacon and, more importantly, for patients in the XLRP community,” said Baldo.

“The VISTA study has been carefully designed to provide the clinical evidence needed to demonstrate laru-zova’s potential to improve functional vision in patients with XLRP,” added Chung. “We are applying our deep understanding of both ocular disease and gene therapy by using a highly efficient AAV capsid and a stabilized gene cassette that expresses the full-length RPGR protein to support better vision outcomes.”

The company noted it continues to progress its phase 2 DAWN trial, of which the company 

released 6-month interim safety and efficacy results

 According to the company, laru-zova was generally well tolerated by all DAWN participants evaluated at 6 months or beyond, and initial data showed promising improvements in visual function across several key measures.

Twelve-month topline data from the VISTA trial are expected in the second half of 2026.

Beacon Therapeutics completes enrollment in registrational Phase 2/3 VISTA trial of laru-zova for patients with XLRP. Published July 8, 2025. Accessed July 8, 2025. 

https://www.beacontx.com/news-and-events/beacon-therapeutics-completes-enrollment-in-registrational-phase-2-3-vista-trial-of-laru-zova-for-patients-with-xlrp/

A Clinical Trial Evaluating the Safety and Efficacy of a Single Subretinal Injection of AGTC-501 in Participants With XLRP. NCT04850118. 

https://clinicaltrials.gov/study/NCT04850118

Crago S. Beacon Therapeutics shares 6-month interim safety and efficacy results from phase 2 DAWN study for XLRP. Published May 8, 2025. Accessed July 8, 2025. 

https://www.ophthalmologytimes.com/view/beacon-therapeutics-shares-6-month-interim-safety-and-efficacy-results-from-phase-2-dawn-study-for-xlrp

The VISTA trial is evaluating and comparing 2 dose levels of laru-zova with an untreated control group for the treatment of X-linked retinitis pigmentosa (XLRP).

Enrollment complete for Beacon Therapeutics' phase 2/3 VISTA trial

RetinalGeniX has contracted with Labcorp to support the rollout of the RetinalGeniX DNA/RNA/GPS Pharmaco-Genetic Mapping platform.

The program allows patients to undergo genetic testing and high-resolution retinal imaging anonymously, providing insights into both ocular and systemic diseases. Through the collaboration, patients may visit any USA-based Labcorp location to have blood, tears, nasal secretions, and saliva collected and analyzed using proprietary algorithms developed by the RetinalGeniX and DNA/RNA/GPS analysis platform.

According to the company, these tests may correlate genetic and retinal biomarkers, ultimately seeking to establish a new standard for early detection of a wide range of health conditions. Patients may elect to have their data analyzed using specific algorithms developed by RetinalGeniX, paired with DNA/RNA/GPS to correlate with current and future biomarkers found in the eye and the blood.

Larry Perich, DO, adviser for the DNA/RNA/GPS program, noted, “As the database of disease-associated biomarkers expands, we expect the value of these platforms for diagnosing both ocular and systemic diseases continues to grow, promising improved outcomes and more accessible care.”

The company specified that patients maintain full control of their health records, which remain anonymous and confidential.

RetinalGeniX stated that high-resolution retinal imaging will be introduced as a value-added service at various locations in the near future. These innovations are designed to make screening more accessible, cost-effective, and capable of detecting disease earlier, according to the company.

Jerry Katzman, MD, CEO of RetinalGenix Technologies, noted that the company is working with regulators to establish CPT codes, which could further help lower health care costs and improve access to necessary evaluations.

RetinalGenix Technologies contracts with LabCorp to support DNA/GPS platform for advanced genetic and retinal health screening. Published June 27, 2025. Accessed June 30, 2025. 

https://avttx.com/ashvattha-therapeutics-presents-positive-interim-phase-2-results-for-subcutaneous-migaldendranib-treatment-for-dme-and-wet-amd-at-2025-maculart-meeting/

RetinalGeniX partners with Labcorp to enhance genetic testing and retinal imaging, aiming for early disease detection and improved patient care.

Marc D. de Smet, MD, PhD

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