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Professor of ophthalmology at the University of Cincinnati

Q&A: 24-month results of the Phase 2 SKYLINE trial for XLRP

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

To strengthen Opus Genetics’ gene therapy program focused on retinol dehydrogenase 12 (RDH12) gene mutations, the company announced its partnership with Global RDH12 Alliance.

 According to a press release, the Alliance serves as a collaborative platform that unites various inherited retinal disease (IRD) advocacy groups, such as “RDH12 Fund for Sight” in the US and “Eyes on the Future” in the UK.

This partnership allows for the continual development of OPGx-RDH12, Opus’ gene therapy program targeting the RDH12 gene mutation for the potential treatment of Leber congenital amaurosis (RDG12-LCA).

 To deliver a functional copy of the RDH12 gene directly to the retina’s photoreceptors, OPGx-RDH12 uses an adeno-associated virus (AAV) vector.

“Preclinical studies in cell and mouse models have shown restoration of RDH12 activity and functional improvements,” Jean Bennett, MD, PhD, Opus Genetics scientific adviser and board of directors member, said in a press release.

Through the partnership, which includes a risk-sharing structure and performance-based milestones, the Alliance will provide up to $1.6 million toward the development of Opus’ OPGx-RDH12 program.

 The goal of the companies is to file an investigational new drug (IND) application with the US Food and Drug Administration (FDA) by late 2025.

“Since founding the RDH12 Fund for Sight more than a decade ago, our goal has always been to bring a treatment to the RDH12-LCA community,” Mathew Pletcher, PhD, board member of the RDH12 Fund for Sight, said in a press release. Pletcher is also the parent of an adult child living with the condition.

RDH12-LCA affects several thousand people globally. Mutations of the RDH12 gene impair protein function in the retina, which leads to early visual decline by age 2 and rapid progression during the second decade of life.

“This partnership represents a significant step forward. By combining our patient community’s unique, first-hand perspectives on RDH12-LCA and resources with Opus’ gene therapy expertise, we can accelerate the transition of this promising therapy out of the laboratory and into the clinic,” Pletcher said.

https://fyra.io. Opus Genetics and the Global RDH12 Alliance Partner to Advance RDH12 Gene Therapy for Inherited Childhood Blindness - Eyewire+. Eyewire+. Published 2025. Accessed July 28, 2025. 

https://eyewire.news/news/opus-genetics-and-the-global-rdh12-alliance-partner-to-advance-rdh12-gene-therapy-for-inherited-childhood-blindness?c4src=article:infinite-scroll

Opus Genetics partners with the Global RDH12 Alliance to advance gene therapy for inherited retinal disease, aiming for FDA application by late 2025.

clinical

Opus Genetics and Global RDH12 Alliance announce partnership

EyePoint Pharmaceuticals recently announced the completion of enrollment for its phase 3 LUCIA trial.

The second of 2 identical ongoing pivotal noninferiority trials, the LUCIA trial is for evaluating DURAVYU for treating 

wet age-related macular degeneration (AMD)

. The first trial, LUGANO, completed enrollment in May 2025. LUCIA has enrolled and randomly assigned more than 400 patients in 7 months, which makes DURAVYU one of the fastest enrolling phase 3 pivotal programs in wet AMD.

“The rapid enrollment of the LUCIA trial reflects its patient-centric design, DURAVYU’s excellent safety profile, and EyePoint’s ongoing engagement with the retinal community,” Anat Loewenstein, MD, MHA, vice president of ambulatory services, head of retina at Tel Aviv Medical Center, president of the European Society of Retina Specialists, and a member of EyePoint’s scientific advisory board, said in a press release.

“With its use of a noninferiority design and on-label aflibercept control, EyePoint’s phase 3 program is designed to generate data relevant to clinical practitioners like myself. Additionally, the 6-month redosing schedule being evaluated would enable greater clinical flexibility and improved [adherence] for patients, representing a potential paradigm shift for the treatment of wet AMD. It is my pleasure to contribute to this cutting-edge research, which holds the promise of improving outcomes for retinal disease patients worldwide.”

Safety and efficacy data from the DAVIO 2 phase 2 clinical trial support 

. The phase 3 pivotal program was developed in alignment with both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

LUGANO and LUCIA are randomized, double-masked, aflibercept-controlled, noninferiority phase 3 trials for the evaluation of DURAVYU’s safety and efficacy for the treatment of wet AMD—including both naive and treatment-experienced patients. Randomly assigned 1:1, patients either receive DURAVYU 2.7-mg treatment or an on-label aflibercept control.

Randomly assigned on day 1, all patients immediately begin treatment with a 1-year efficacy and safety end point to support the NDA filing, a press release said.

 Top-line data of LUGANO are expected in mid-2026, followed shortly after by LUCIA. DURAVYU is delivered via intravitreal injection.

“With enrollment now complete for our phase 3 wet AMD program, well ahead of our expectations, we continue to demonstrate exceptional execution and our deep commitment to the retinal disease community,” Jay S. Duker, MD, president and chief executive officer of EyePoint, said in a press release.

“The industry-leading pace of our clinical program is a testament to the patient and physician enthusiasm for innovative, novel, and more durable wet AMD treatments and DURAVYU’s compelling and differentiated profile. As we look ahead to anticipated top-line data for LUGANO in mid-2026 and LUCIA to follow, we remain focused on bringing the first sustained-release TKI for wet AMD to market and advancing our mission of delivering transformative treatment options for patients.”

EyePoint Completes Enrollment of Pivotal Phase 3 Trials for DURAVYU

 in Wet Age-Related Macular Degeneration - EyePoint Pharmaceuticals. EyePoint Pharmaceuticals. Published 2025. Accessed July 29, 2025. 

https://investors.eyepointpharma.com/news-releases/news-release-details/eyepoint-completes-enrollment-pivotal-phase-3-trials-duravyutm

EyePoint Pharmaceuticals completes enrollment for the LUCIA trial, advancing DURAVYU's potential as a new treatment for wet AMD.

EyePoint completes enrollment of LUGANO and LUCIA trials

Kiora Pharmaceuticals recently announced the receipt of a patent for the company’s ocular therapy KIO-104.

 KIO-104 is for the treatment of a wide range of ocular diseases, including ocular inflammation, uveitis, age-related macular degeneration, and complications as a result of refractive surgery. Along with other novel treatment methods for ocular inflammatory diseases, the patent (US Patent No. 12,364,680) also covers varying dosing schedules and necessary excipients.

“Securing this patent builds on our IP strategy to protect KIO-104 around its proprietary structure, delivery methods, formulation, and therapeutic applications,” Brian M. Strem, PhD, president and CEO of Kiora, said in a press release. “This specific patent is significant in its breadth of therapeutic applications.”

A small molecule in development for inflammatory retinal diseases, KIO-104 offers an alternative treatment method to steroids or systemic anti-inflammatory drugs. It works by inhibiting the mitochondrial enzyme DHODH, which plays a key role in the synthesis of key building blocks of DNA and RNA.

The KLARITY study, a multicenter phase 2 clinical trial, is currently screening patients to evaluate the role of KIO-104 in up to 28 patients at 2 dose levels across various forms of inflammatory retinal diseases.

 The results from the initial stage study will inform dose expansion.

The patent issuance is expected to further strengthen the protection of KIO-104 and extend market exclusivity into 2043, the company said in a press release.

Kiora Pharmaceuticals, Inc. Kiora Pharmaceuticals, Inc. Published July 22, 2025. Accessed July 23, 2025. 

https://ir.kiorapharma.com/news-events/news-releases/detail/235/kiora-pharmaceuticals-granted-u-s-patent-expanding-protection-for-kio-104-in-the-treatment-of-ocular-disease

Kiora Pharmaceuticals secures a patent for KIO-104, enhancing treatment options for ocular diseases and extending market exclusivity until 2043.

Kiora Pharmaceuticals receives patent for KIO-104

ANI Pharmaceuticals announced results from its NEW DAY clinical trial of ILUVIEN (fluocinolone acetonide intravitreal implant), 0.19 mg for patients with 

ILUVIEN is a corticosteroid indicated for treating DME in patients previously treated with a course of corticosteroids who did not have a clinically significant rise in intraocular pressure (IOP).

NEW DAY is a prospective, multicenter, masked, randomized, active-controlled trial that enrolled 306 eyes of treatment-naive, or almost naive, DME patients at approximately 42 sites around the US. Patients enrolled were older than 18 years with a diagnosis of type 1 or type 2 diabetes with a center-involving DME confirmed by SD-OCT, and CST of ≥ 350 µm and best corrected visual acuity (BCVA) of ≥35 ETDRS letters and ≤80 ETDRS letters in the study eye at the screening visit. The trial's primary end point was the mean total number of supplemental aflibercept injections needed for the treatment of DME in the ILUVIEN arm compared to the aflibercept arm over the 18-month study period in the intent-to-treat (ITT) population.

Patients were randomly assigned to either an ILUVIEN arm (n=154), where they received an ILUVIEN intravitreal implant, or an aflibercept arm (n=152), where they received 5 injections of anti-VEGF therapy (intravitreal aflibercept 2 mg) at 4-week intervals for the first 16 weeks of the trial during an induction period.

At the end of the 16-week induction period, patients in both arms were evaluated every 4 weeks during a 13-month maintenance period and received supplemental aflibercept injections only as needed.

According to the company, treatment with ILUVIEN demonstrated a numerical reduction in the mean number of supplemental aflibercept injections compared with the aflibercept arm. However, it did not reach the threshold for statistical significance (2.4 vs. 2.5; 

 = .756), and therefore the primary end point was not met. The secondary end point of mean time from last treatment injection to first supplemental aflibercept injection was met with a mean time of 185.4 days in the ILUVIEN arm, compared to 132.8 days in the aflibercept arm (

 < .001). Additionally, 33% of patients in the ILUVIEN arm did not require a supplemental injection during the study compared to 30% in the aflibercept arm.

Secondary end points that assessed visual acuity and anatomic changes in the ITT population demonstrated noninferiority between the ILUVIEN arm and the aflibercept arm, and additional secondary end points will be further evaluated by the company.

A post hoc analysis was conducted on a subset of randomly assigned patients without major protocol deviations, which showed that the ILUVIEN arm (n=128) demonstrated a statistically significant difference in the mean number of supplemental aflibercept injections compared to the aflibercept arm (n=134), with 1.8 vs 2.5 injections, respectively (

 = .029). Therefore, patients in the post hoc analysis received a total of 2.8 injections in the ILUVIEN arm, whereas the aflibercept arm patients received a total of 7.5 injections.

Michael A. Singer, MD, clinical professor of ophthalmology at the University of Texas Health Science Center and director of clinical research at Medical Center Ophthalmology Associates in Texas, commented on the results in a press release.

“The NEW DAY study provides clinically meaningful data on ILUVIEN’s potential impact on treatment burden, including a statistically significant difference in time to first supplemental injection of aflibercept in the ILUVIEN arm compared to the aflibercept arm. This potential reduction in treatment burden can be critical for our patients with diabetic macular edema, as their disease is multifactorial, necessitating multiple visits to medical specialists.”

Safety data were reported as “consistent with data from prior ILUVIEN clinical trials and real-world use.” In the ITT patient population, 41% of patients in the ILUVIEN arm experienced treatment-related treatment-emergent adverse events, compared with 3% in the aflibercept arm. The company notes that these were mainly associated with cataract/subcapsular cataract (n=50) and an increase in IOP (n=24). Additionally, 16% of patients in the ILUVIEN arm experienced an increase in IOP compared with 3% in the aflibercept arm, whereas 11% of patients experienced an increase in IOP of ≥25 mm Hg compared with 3% in the aflibercept arm.

ANI Pharmaceuticals Announces Results from NEW DAY Clinical Trial of ILUVIEN® for Use in Patients with Diabetic Macular Edema (DME). Published July 23, 2025. Accessed July 24, 2025. 

https://www.globenewswire.com/de/news-release/2025/07/23/3120083/0/en/ANI-Pharmaceuticals-Announces-Results-from-NEW-DAY-Clinical-Trial-of-ILUVIEN-for-Use-in-Patients-with-Diabetic-Macular-Edema-DME.html

ANI Pharmaceuticals releases results for ILUVIEN in treating diabetic macular edema.

Canonical

NEW DAY trial of ILUVIEN for DME does not meet primary end point; post hoc analysis suggests potential benefits

In a press release, Aldeyra Therapeutics, Inc, announced that the European Medicines Agency (EMA) has granted orphan designation for its methotrexate intravitreal injection (ADX-2191). The therapeutic candidate is formulated to treat inherited retinal dystrophies, including retinitis pigmentosa (RP). ADX-2191 is being investigated for performance in 

In 2021, the FDA granted orphan drug designation to ADX-2191.

 The phase 2 trial supporting the EMA's decision this week was originally announced in 2023. Data from that trial demonstrated improvements from baseline in retinal sensitivity. The company, based in Lexington, Massachusetts, plans to initiate a phase 2/3 trial further examining ADX-2191 for RP later in 2025.

In the European Union, orphan designation grants companies a number of benefits: reduced regulatory fees, research grants, clinical protocol support, and potential long-term market exclusivity throughout the EU. The EMA grants orphan designation to drugs/biologics intended to address life-threatening or chronically debilitating diseases that affect fewer than 5 in 10,000 EU residents.

Todd C. Brady, MD, PhD, president and CEO of Aldeyra Therapeutics, said the orphan designation will expand access to therapies for RP and other inherited retinal dystrophies. “Retinitis pigmentosa is a serious and incurable sight-threatening disease that represents a major unmet need in the field of ophthalmology,” Brady said in the press release.

 “The receipt of orphan designation from the EMA, in conjunction with the previously announced orphan drug designation from the [FDA], highlights the importance of developing a treatment option for patients suffering from retinitis pigmentosa.”

Currently, there are no approved treatments for RP, a group of genetic eye diseases characterized by retinal cell death and subsequent loss of visual acuity. In the press release, Aldeyra Therapeutics provided information about the functional utility of its methotrexate intravitreal injection. In vivo preclinical research identified methotrexate as an agent to induce misfolded rhodopsin clearance. Rhodopsin, a protein found in the rod cells, is light-sensitive and crucial to the visual cycle. ADX-2191 is a sterile, noncompounded intravitreal formulation of methotrexate that is preservative-free and vitreous-compatible. The US FDA's orphan drug designation applies to the use of ADX-2191 in treating RP and primary vitreoretinal lymphoma.

Aldeyra Therapeutics designs pharmaceuticals that modulate protein systems, rather than functioning with a protein inhibitor/activator model. Along with ADX-2191, the company's other late-stage product candidate is reactive aldehyde species (RASP) modulator reproxalap, indicated as a potential therapy for dry eye disease and allergic conjunctivitis. Other product candidates from the company include RASP modulators ADX-629, ADX-248, ADX-743, ADX-631, and ADX-246.

Aldeyra Therapeutics Receives Orphan Designation from the European Medicines Agency for ADX-2191 for the Treatment of Inherited Retinal Dystrophies including Retinitis Pigmentosa. Press release. Aldeyra Therapeutics. Published July 24, 2024. Accessed July 24, 2025. 

https://www.businesswire.com/news/home/20250724869031/en/Aldeyra-Therapeutics-Receives-Orphan-Designation-from-the-European-Medicines-Agency-for-ADX-2191-for-the-Treatment-of-Inherited-Retinal-Dystrophies-including-Retinitis-Pigmentosa

Kaiser Maharjan E. U.S. FDA grants orphan drug designation to ADX-2191 from Aldeyra Therapeutics. 

. Published August 5, 2021. Accessed July 24, 2025. https://europe.ophthalmologytimes.com/view/u-s-fda-grants-orphan-drug-designation-to-adx-2191-from-aldeyra-therapeutics

Findings from a phase 2 clinical trial support the therapeutic potential of ADX-2191 in patients with retinitis pigmentosa.

Robert A. Sisk, MD, FACS, FASRS

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