Eyepoint Pharmaceuticals, Inc. (NASDAQ: EYPT) recently released positive interim 16-week data for its ongoing phase 2 Verona clinical trial evaluating Duravyu, an investigational sustained delivery therapy delivering patent-protected vorolanib, a selective tyrosine kinase inhibitor formulated in proprietary bioerodible Durasert E™, for patients with diabetic macular edema (DME).
The results showed that Duravyu 2.7mg demonstrated an early and sustained improvement in best-corrected visual acuity (BCVA) with a gain of +8.9 letters compared to baseline. Additionally, Duravyu 2.7mg demonstrated an early and sustained anatomical improvement mirroring BCVA results with a 68 micron reduction in central subfield thickness (CST).
The interim data also revealed a favorable safety profile, with no Duravyu-related ocular or systemic serious adverse events reported to date. Furthermore, 82% of eyes in the Duravyu 2.7mg arm were supplement-free versus 50% in the aflibercept control arm at 16 weeks.
Dr. Jay S. Duker, President and Chief Executive Officer of Eyepoint Pharmaceuticals, expressed optimism about the interim results, emphasizing the potential for Duravyu to advance to non-inferiority pivotal trials in DME. He highlighted the immediate benefit over aflibercept control in both BCVA and CST for both Duravyu doses, stating that the compelling interim results support Duravyu's potential in two significant indications.
These results are particularly promising given the prevalence of DME, which affects approximately 28 million people worldwide, making it the leading cause of vision loss in individuals with type 1 and type 2 diabetes. The current standard of care for DME involves frequent intravitreal injections, and the positive interim data from the Verona trial suggests promising activity in patients with active DME versus aflibercept alone.
The Verona trial is a randomized, controlled, single-masked, open-label phase 2 trial of Duravyu in DME patients previously treated with a standard-of-care anti-VEGF therapy. The primary efficacy endpoint of the Verona trial is time to first supplemental aflibercept injection up to 24 weeks.
Eyepoint Pharmaceuticals is also evaluating Duravyu in phase 3 pivotal trials for wet age-related macular degeneration (wet AMD), with promising interim data supporting its potential as a sustained release therapy in this indication as well.
The company expects to report full topline results for the Verona trial in the first quarter of 2025, once all patients complete the trial. These results could potentially position Duravyu as a paradigm-altering treatment for patients suffering from VEGF-mediated retinal diseases, offering a promising alternative to the current standard of care that involves frequent injections and treatment burden for patients, caregivers, and physicians.
Eyepoint Pharmaceuticals is headquartered in Watertown, Massachusetts, and its lead product candidate, Duravyu, is presently in phase 3 global, pivotal clinical trials for wet AMD and in a phase 2 clinical trial in DME.
The company is focused on developing and commercializing innovative therapeutics to help improve the lives of patients with serious retinal diseases, leveraging its proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery. Following these announcements, the company's shares moved 26.3%, and are now trading at a price of $12.0. If you want to know more, read the company's complete 8-K report here.
