EyePoint Pharmaceuticals Inc. (EYPT) stock experienced a significant surge on Monday, fueled by the release of positive interim data from the ongoing Phase 2 VERONA trial of its investigational drug, Duravyu, for the treatment of diabetic macular edema (DME).
Duravyu, a sustained-delivery therapy, delivers vorolanib, a selective tyrosine kinase inhibitor, formulated in a bioerodible Durasert E delivery system. The interim data from the VERONA trial revealed that Duravyu 2.7mg demonstrated an early, sustained, and clinically meaningful improvement in best-corrected visual acuity (BCVA) and anatomical control when compared to Regeneron Pharmaceuticals Inc.’s Eylea (aflibercept), the current standard of care for DME.
The 2.7mg dose of Duravyu, which is also being evaluated in pivotal Phase 3 trials for wet age-related macular degeneration (wet AMD), showed encouraging results. At 16 weeks, patients treated with Duravyu 2.7mg experienced a notable improvement in BCVA, with an average gain of +8.9 letters compared to a +3.2 letter gain in the Eylea control group. Additionally, central subfield thickness (CST), a measure of retinal swelling, improved by 68.1 microns in the Duravyu group compared to 30.5 microns in the Eylea group.
These visual and anatomical gains were observed as early as Week 4 of the trial, highlighting the rapid bioavailability of Duravyu. Importantly, the positive trend in BCVA and anatomy continued for patients who reached the Week 24 visit, indicating the long-lasting effects of the treatment.
Furthermore, the data demonstrated an encouraging safety and tolerability profile for Duravyu. No Duravyu-related ocular or systemic serious adverse events were reported. Notably, at 16 weeks, 2% of eyes in the Duravyu 2.7mg arm were supplement-free, compared to 50% in the Eylea control arm. This suggests that Duravyu may potentially reduce the need for frequent injections, a significant advantage for patients.
The positive interim data from the VERONA trial has generated considerable excitement among investors, leading to a substantial increase in EYPT stock price. The company expects to report full topline results from the Phase 3 trials for wet AMD in the first quarter of 2025. If the final data confirms these positive findings, Duravyu could potentially become a valuable new treatment option for patients with DME and wet AMD, significantly impacting the ophthalmic drug market.
