EyePoint Pharmaceuticals has announced positive interim 16-week data from its Phase 2 VERONA clinical trial, evaluating DURAVYU for patients with diabetic macular edema (DME). The investigational sustained delivery therapy, which delivers vorolanib, a selective tyrosine kinase inhibitor, showed early and sustained improvement in both best-corrected visual acuity (BCVA) and anatomical control compared to the aflibercept control arm.
The data, as of the October 1, 2024, cutoff, indicated that DURAVYU 2.7mg led to an 8.9 letter gain in BCVA compared to a 3.2 letter gain in the aflibercept control group from baseline. Furthermore, central subfield thickness (CST) improved by 68.1 microns in the DURAVYU arm versus 30.5 microns in the aflibercept arm. These visual and anatomical gains were observed as early as Week 4, demonstrating the immediate bioavailability of DURAVYU.
Clinical Significance
"DME is a sight-threatening complication of diabetes that can lead to severe visual loss and eventual blindness," said Charles Wykoff, M.D., Ph.D., Director of Research, Retina Consultants of Texas and Co-Chair of EyePoint’s Scientific Advisory Board. "There remains a significant need for differentiated and longer-acting treatments, as the current standard of care involves frequent intravitreal injections that can be a burden and have been associated with under-treatment."
The interim data also revealed a positive trend in BCVA and anatomy for patients who reached the Week 24 visit. Notably, 82% of eyes in the DURAVYU 2.7mg arm were supplement-free versus 50% in the aflibercept control arm at 16 weeks. The safety profile remained favorable, with no DURAVYU-related ocular or systemic serious adverse events, including endophthalmitis, retinal vasculitis, insert migration, or intraocular inflammation.
VERONA Trial Design
The VERONA trial is a randomized, controlled, single-masked, open-label Phase 2 study involving 27 DME patients previously treated with anti-VEGF therapy. Participants were assigned to one of two intravitreal doses of DURAVYU (1.3mg or 2.7mg) or aflibercept control. The primary efficacy endpoint is the time to first supplemental aflibercept injection up to 24 weeks. Secondary endpoints include safety, mean change in BCVA, mean change in CST, and change in diabetic retinopathy severity scale (DRSS) over time.
DURAVYU's Mechanism of Action
DURAVYU delivers vorolanib via EyePoint’s Durasert E technology, providing sustained release for up to nine months. Vorolanib inhibits all VEGF receptors and has shown neuroprotective and antifibrotic benefits in preclinical models. The drug is administered via intravitreal injection in the physician's office and is stored at ambient temperature.
Future Outlook
EyePoint anticipates reporting full topline results from the VERONA trial in the first quarter of 2025. The company has already initiated a Phase 3 pivotal trial (LUGANO) of DURAVYU in wet age-related macular degeneration (AMD) and expects to dose the first patient in the second Phase 3 LUCIA trial by the end of 2024. With positive clinical data and a strong financial position following a $161.0 million equity financing, EyePoint is optimistic about DURAVYU’s potential as a sustained-release maintenance therapy for VEGF-mediated retinal diseases.
