EyePoint Pharmaceuticals announced positive interim 16-week data for the ongoing Phase 2 VERONA clinical trial evaluating DURAVYU, an investigational sustained-delivery therapy delivering patented vorolanib, a selective tyrosine kinase inhibitor formulated in proprietary bioerodible Durasert E, for patients with diabetic macular edema (DME). 

DURAVYU 2.7 mg demonstrated an early, sustained, and clinically meaningful improvement in BCVA and anatomical control vs the aflibercept control arm. A favorable safety and tolerability profile continued for both DURAVYU arms, the company said in a press release. 

Reported in the Phase 2 VERONA interim 16-week results as of the Oct. 1, 2024 data cut-off, EyePoint Pharmaceuticals noted that all patients (n=27) completed the week 16 visit. DURAVYU 2.7 mg demonstrated an early and sustained improvement in both BCVA and CST (central subfield thickness) as measured by optical coherence tomography (OCT) — BCVA improved +8.9 letters vs +3.2 letters for aflibercept control compared to baseline; and CST improved 68.1 microns vs 30.5 microns for aflibercept control compared to baseline. In addition, visual and anatomical gains were observed at Week 4 demonstrating the immediate bioavailability of DURAVYU. Positive trend in BCVA and anatomy continued for patients that have reached the Week 24 visit.

The company also reported a continued positive safety and tolerability profile with no DURAVYU-related ocular or systemic serious adverse events. Additionally, the investigators found no cases of: endophthalmitis, retinal vasculitis (occlusive or non-occlusive), insert migration to the anterior chamber or intraocular inflammation. The company said 82% of eyes in the DURAVYU 2.7-mg arm were supplement-free vs 50% in the aflibercept control arm at 16 weeks.

According to the press release, the 2.7-mg dose is also being evaluated in the Phase 3 pivotal trials for wet AMD. The company says it expects to report the full topline results in the first quarter of 2025, once all patients complete the trial.

VERONA 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 trial enrolled 27 patients assigned to one of two intravitreal doses of DURAVYU (1.3 mg or 2.7 mg) or aflibercept control. The primary efficacy endpoint of the VERONA trial is time to first supplemental aflibercept injection up to 24 weeks based on established supplement criteria. Key secondary endpoints include safety, mean change in BCVA, mean change in CST as measured by OCT and change in diabetic retinopathy severity scale over time. More information about the trial is available at clinicaltrials.gov (identifier: NCT06099184).