Eyepoint, Inc. (NASDAQ: EYPT) has announced that it has dosed the first patients in both global Phase 3 clinical trials of Duravyu™ for the treatment of diabetic macular edema (DME). This development marks a significant milestone for the company, positioning Duravyu as the only tyrosine kinase inhibitor (TKI) in Phase 3 clinical trials for DME. The trials, named Como and Capri, are designed to position Duravyu as a potential first-in-class and best-in-class TKI for DME.
The Duravyu DME program consists of two global, randomized, double-masked, on-label aflibercept controlled non-inferiority trials, each enrolling approximately 240 patients. The primary endpoint for both trials is a non-inferior change from baseline in best corrected visual acuity (BCVA) to weeks 52 and 56, blended versus aflibercept control. Secondary endpoints include safety, superiority in reduction in treatment burden, percentage of eyes free of supplemental aflibercept injections, and anatomical results as measured by optical coherence tomography (OCT).
Notably, the Phase 2 Verona trial in DME met primary and secondary endpoints and demonstrated rapid and sustained improvement in vision and anatomy, as well as a favorable safety and tolerability profile with superior dosing intervals to standard of care.
In addition to DME, Duravyu is also being evaluated for the treatment of wet age-related macular degeneration (wet AMD), with over 900 patients randomized across the Phase 3 pivotal program. Topline data for wet AMD is expected to be reported beginning in mid-2026.
Eyepoint is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases. The company's lead product candidate, Duravyu, combines vorolanib, a selective and patent-protected tyrosine kinase inhibitor, in next-generation bioerodible Durasert E™ technology.
With the dosing of the first patients in the Phase 3 clinical trials for DME, Eyepoint is poised to make significant strides in addressing the treatment needs of patients with DME, which is the leading cause of vision loss in people with type 1 and type 2 diabetes. As the company continues to advance its clinical programs, the retinal community awaits eagerly for the potential impact of Duravyu in addressing the unmet needs of patients with serious retinal diseases. As a result of these announcements, the company's shares have moved -4.8% on the market, and are now trading at a price of $15.08. Check out the company's full 8-K submission here.
