EyePoint Pharmaceuticals details phase 3 program evaluating vorolanib intravitreal insert (DURAVYU) for DME

EyePoint Pharmaceuticals has released details for its pivotal phase 3 program evaluating vorolanib intravitreal insert (DURAVYU) for the treatment of diabetic macular edema (DME).

Additionally, the company shared data that shows vorolanib, the active drug in DURAVYU, inhibits interleukin-6 (IL-6)-mediated inflammation through the inhibition of all JAK receptors, in particular JAK-1. According to the company, this discovery validates early and sustained improvements observed through 6 months in the phase 2 VERONA clinical trial.

The phase 2 VERONA trial in DME met primary and secondary endpoints and demonstrated a “rapid and sustained improvement in vision and anatomy, a continued favorable safety and tolerability profile with superior dosing intervals to standard of care.”

Yasha S. Modi, MD, an associate professor of ophthalmology at NYU Langone, gave Ophthalmology Times additional insight into the VERONA study at this year’s American Society of Retina Specialists (ASRS) meeting.

DURAVYU is being developed as a potential sustained-delivery treatment for patients suffering from serious retinal diseases and is designed for intravitreal dosing in a pre-loaded syringe injector to deliver a consistent therapeutic dose for at least 6 months.

According to the company, the phase 3 program will consist of 2 identical non-inferiority trials named COMO and CAPRI and will include redosing of DURAVYU every 6 months. Each trial is expected to enroll around 240 patients, including both treatment-naïve and previously treated patients. They will be randomized to either a DURAVYU 2.7 mg arm or an on-label 2 mg aflibercept control arm. The primary endpoint will be the change from baseline in best corrected visual acuity (BCVA) to weeks 52 and 56, blended, compared to on-label 2 mg aflibercept.

Ramiro Ribeiro, MD, PhD, Chief Medical Officer at EyePoint, commented on the trial design in a press release from the company, saying, “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.”

Regarding the new data for DURAVYU, the company noted it has the potential to be a multi-MOA treatment, inhibiting both VEGF via inhibition of all VEGFRs and IL-6 signaling via JAK receptor blockage.

Roger A. Goldberg, MD, MBA, vitreoretinal surgeon at Bay Area Retina Associates, commented on the treatment in a press release, saying, “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. I am thrilled that DURAVYU—the only TKI in development for a center involving DME—plans to advance to a registrational program.”

The company plans on dosing the first patient in the phase 3 program in Q1 of 2026.

References:

1. EyePoint Announces Pivotal Phase 3 Program Initiation for DURAVYU™ in Diabetic Macular Edema. Published October 14, 2025. Accessed October 15, 2025. https://www.globenewswire.com/news-release/2025/10/14/3166631/0/en/EyePoint-Announces-Pivotal-Phase-3-Program-Initiation-for-DURAVYU-in-Diabetic-Macular-Edema.html