First Patient Receives EYP-1901 Dose in Phase 2 DME Clinical Trial by EyePoint

EyePoint Pharmaceuticals, a biopharmaceutical firm focused on therapeutics for severe retinal conditions, has initiated a Phase 2 clinical trial for EYP-1901, a novel treatment for diabetic macular edema (DME). The trial, dubbed VERONA, marks a significant step in the company's pursuit to enhance patient care, particularly for those afflicted with DME, a prevalent complication of diabetes that can result in substantial vision impairment.

Jay Duker, EyePoint's CEO, underscored the importance of this trial, highlighting the need for more effective and enduring treatments for DME. The current standard of care, which involves frequent intravitreal injections, can be onerous and may lead to inadequate treatment. Duker expressed optimism about EYP-1901's potential to revolutionize DME treatment, with preliminary data expected in the first quarter of 2025.

The VERONA trial is a randomized, controlled, single-masked study involving approximately 25 participants who have previously received standard anti-VEGF therapy. The trial will assess two different intravitreal doses of EYP-1901 against an aflibercept control. The primary goal is to measure the time to the first supplemental aflibercept injection, with secondary objectives encompassing safety, visual acuity changes, and other retinal assessments.

DME is a leading cause of vision loss among diabetics, caused by fluid leakage from damaged blood vessels into the macula, the retina's central area responsible for clear vision. With diabetes prevalence on the rise, DME's impact is growing, affecting an estimated 28 million individuals globally.

EYP-1901 is being developed as a groundbreaking treatment for VEGF-mediated retinal diseases, using vorolanib, a selective tyrosine kinase inhibitor, within EyePoint's proprietary Durasert E™ sustained-release technology. Vorolanib offers a unique approach to treating these diseases by inhibiting all VEGF receptors and has shown neuroprotective and antifibrotic benefits in models of retinal detachment.

Previous trials of EYP-1901 in wet age-related macular degeneration (AMD) have yielded promising results, demonstrating meaningful efficacy and a favorable safety profile. The DAVIO 2 trial showed a significant reduction in treatment burden, with most patients requiring minimal or no supplemental injections. These findings support the progression to Phase 3 pivotal trials for wet AMD, expected to commence later in 2024.

EyePoint Pharmaceuticals, headquartered in Watertown, Massachusetts, is leveraging its Durasert E™ technology to develop a pipeline of therapeutics aimed at improving the lives of those with serious retinal diseases. The company's lead candidate, EYP-1901, combines vorolanib with Durasert E™, while other programs, such as EYP-2301, a TIE-2 agonist, and razuprotafib, are also in development to potentially enhance outcomes in retinal conditions.