EyePoint Pharmaceuticals Unveils Phase 3 Program for DURAVYU in Diabetic Macular Edema

EyePoint Pharmaceuticals has released details of its pivotal phase 3 clinical program for DURAVYU (vorolanib intravitreal insert), a sustained-release investigational therapy designed for the treatment of diabetic macular edema (DME). The announcement builds on promising phase 2 results and highlights DURAVYU’s unique multi-mechanism potential to address both vascular and inflammatory drivers of disease.

Phase 3 Program: COMO and CAPRI Trials

The phase 3 program will consist of two identical, randomized, non-inferiority trials, COMO and CAPRI. Each study aims to enroll approximately 240 patients, including both treatment-naïve and previously treated individuals with center-involving DME.

Patients will be randomized to receive either:

       • DURAVYU 2.7 mg administered intravitreally every six months

       • Aflibercept 2 mg, administered according to the approved on-label dosing schedule

The primary endpoint for both trials is the change in best corrected visual acuity (BCVA) from baseline, assessed at weeks 52 and 56 (blended), in comparison to aflibercept.

“Following a positive end-of-phase 2 meeting with the FDA, we are pleased to announce the initiation of our phase 3 pivotal trials for DME, following an established non-inferiority approval pathway for this important indication,” said Ramiro Ribeiro, MD, PhD, Chief Medical Officer at EyePoint Pharmaceuticals.

DURAVYU is being developed as a sustained-delivery intravitreal treatment for patients with serious retinal diseases. The pre-loaded syringe injector is designed to deliver a consistent therapeutic dose for at least six months, with the goal of reducing treatment burden.

The active compound, vorolanib, is a tyrosine kinase inhibitor (TKI) that EyePoint describes as targeting multiple disease pathways. Beyond its known VEGF inhibition via VEGFR blockade, new data indicate that vorolanib also inhibits interleukin-6 (IL-6) signaling by blocking all JAK receptors, with a particular focus on JAK-1. This multi-mechanism of action (multi-MOA) approach could position DURAVYU as a differentiated therapeutic in the DME space.

Phase 2 VERONA Trial

The design and launch of the phase 3 program are informed by data from the phase 2 VERONA trial, which met both its primary and secondary endpoints. The study demonstrated rapid and sustained improvements in visual acuity and retinal anatomy, with a favorable safety and tolerability profile and superior dosing intervals compared to standard anti-VEGF therapy.

“We know that inflammation plays a critical role in the pathogenesis of DME, and there is an urgent need for new treatment options that address the multifactorial nature of this disease while reducing the high treatment burden associated with existing therapies,” said Roger A. Goldberg, MD, MBA, vitreoretinal surgeon at Bay Area Retina Associates.
“I am thrilled that DURAVYU, the only TKI in development for center-involving DME, plans to advance to a registrational program.”

EyePoint Pharmaceuticals expects to dose the first patient in Q1 2026, marking the official start of its registrational program for DURAVYU.