Novel sustained-release DME therapy shows promising results

A novel treatment that uses a disintegrating matrix for sustained release of medication led to improvement in vision and reduced supplemental treatment in patients with diabetic macular edema, according to phase 2 data presented at the FLORetina ICOOR International Congress on OCT and OCT angiography in December 2025.

Diabetic macular edema affects about 75,000 people in the United States and 100 million people globally. It occurs when damaged blood vessels in the retina leak into and cause swelling in the macula, the central area of the retina responsible for the sharp vision needed for reading and driving.

Duravyu, developed by EyePoint Pharmaceuticals, combines vorolanib with the company’s matrix that is designed to degrade and release a constant therapeutic dose for at least six months. Vorolanib is a tyrosine kinase inhibitor (TKI) that targets both VEGF-mediated vascular permeability and IL-6-mediated inflammation through inhibition of all VEGF and JAK1 receptors. Duravyu, also known as EYP-1901, is administered through an intravitreal injection with a sterile, prefilled syringe injector.

The phase 2 VERONA trial enrolled 27 patients: 10 who received Duravyu 1.3 mg, 11 who received Duravyu 2.7 mg, and six who received Eylea (aflibercept) 2 mg as a single injection. The primary outcome was time to supplemental Eylea injection following administration of Duravyu compared with Eylea at week 24. The secondary outcome was change in best corrected visual acuity (BCVA) vision.

Data released from the VERONA trial found that the therapy met its endpoint of extended time to first supplemental treatment, and a majority of patients were supplement-free up to week 24. Duravyu also resulted in clinically meaningful improvement in best corrected visual acuity, with vision improved more than 10 letters from baseline.

Duravya was well-tolerated, with no ocular-related or system-related serious adverse events. Additionally, there were no cases of endophthalmitis, retinal vasculitis, intraocular inflammation, or insert migration into the anterior chamber. No patients discontinued the trial.

Phase 3 trials of Duravyu to treat patients with diabetic macular edema are under way, with the first patient dose to be administered in the first quarter of 2026. Two trials will each enroll approximately 240 patients, including both previously treated and treatment-naïve patients, randomly assigned to a Duravyu 2.7 mg arm or an on-label 2 mg Eylea control arm. Randomization occurs on Day 1 with Duravyu 2.7 mg redosing every six months.

The primary endpoint is the change from baseline in best corrected visual acuity (BCVA) to weeks 52 and 56, blended, compared with on-label 2 mg Eylea.

Duravyu is also being evaluated in two phase 3 trials to treat patients with wet age-related macular degeneration (wet AMD). Age-related macular degeneration occurs when the macula, part of the retina at the back of the eye, becomes damaged. About 10% of all cases become wet, which leads to vision loss as a result of excess blood vessel growth between two layers of cells in the retina. It is also called neovascular AMD.

The pivotal program for wet AMD (LUGANO and LUCIA) is evaluating every six-month dosing of Duravyu. The primary endpoint of the phase 3 trials is non-inferiority with aflibercept in the average change in best corrected visual acuity at weeks 52 and 56 compared with baseline. Secondary endpoints include safety, reduction in treatment burden, percentage of eyes free of supplemental aflibercept injections, and anatomical results as measured by optical coherence tomography.

Data from the DAVIO 2 phase 2 trial in wet AMD demonstrated an 88% reduction in treatment burden six months after treatment with Duravyu, with more than 80% of patients supplement-free or receiving only one supplemental anti-VEGF injection. No new safety signals were seen. The company indicated that the trials are on track to report topline 56-week data for LUGANO in mid-2026, with LUCIA data to closely follow.