EyePoint doses first patient in COMO and CAPRI, phase 3 trials of DURAVYU

EyePoint has dosed the first patient in its phase 3 trials COMO and CAPRI evaluating DURAVYU (vorolanib intravitreal insert) for the treatment of diabetic macular edema (DME). DURAVYU is an investigational sustained delivery therapy delivering vorolanib, a selective tyrosine kinase inhibitor (TKI), described by the company to “bring a novel, multi-mechanism of action inhibiting VEGF-mediated vascular permeability, PDGF, and IL-6-mediated inflammation to the potential treatment of DME.”

The DURAVYU DME program from EyePoint consists of both COMO and CAPRI, randomized, double-masked, on-label aflibercept controlled non-inferiority trials assessing the safety and efficacy of DURAVYU in patients with DME, including both treatment-naïve and previously treated patients. Each trial is expected to enroll approximately 240 patients who will then be randomized into a DURAVYU 2.7 mg dose arm or aflibercept control arm on day 1. Patients who are entered into the DURAVYU arm will be re-dosed every 6 months.

Ramiro Ribeiro, MD, PhD, chief medical officer of EyePoint, commented, “Together, these trials are designed to position DURAVYU with the potential to be the first-in-class and best-in-class TKI for DME, a disease that continues to cause vision loss and significant treatment burden despite available anti-VEGF therapies.”

The primary endpoint of the trials is a non-inferior change from baseline in best corrected visual acuity (BCVA) to weeks 52 and 56, blended versus aflibercept control. Secondary endpoints include safety, superiority in reduction in treatment burden, percentage of eyes free of supplemental aflibercept injections, and anatomical results as measured by optical coherence tomography (OCT).

David Eichenbaum, MD, principal investigator in the CAPRI clinical trial and director of research for Retina Vitreous Associates, commented on the trial, noting, ““There is a clear need for more durable and differentiated treatment options for patients with DME. The current standard of care is overly burdensome for a largely working-age population, and existing therapies do not fully address the underlying disease, as up to two-thirds of DME patients still have active disease after anti-VEGF loading.”

“DURAVYU is designed to provide consistent dosing for at least 6 months, potentially helping to protect vision between visits. We are excited to participate in the phase 3 program, as this marks an important and needed milestone for the retinal community,” concluded Eichenbaum.

EyePoint released the details of the trials in October 2025, while also sharing data showing 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 validated 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.”

DURAVYU is also being evaluated for the treatment of age-related macular degeneration (AMD). The phase 2 DAVIO trial achieved statistically positive and clinically meaningful results compared to on-label aflibercept. Additional data from the AMD phase 3 program is expected in mid-2026.

EyePoint noted data from the phase 3 DME program is anticipated to be released in the second half of 2027.

References:

1. EyePoint Announces First Patients Dosed in Both Global Phase 3 Clinical Trials of DURAVYU™ for the Treatment of Diabetic Macular Edema. Published March 2, 2026. Accessed March 2, 2026. https://investors.eyepoint.bio/news-releases/news-release-details/eyepoint-announces-first-patients-dosed-both-global-phase-3

2. Harp MD. EyePoint Pharmaceuticals details phase 3 program evaluating vorolanib intravitreal insert (DURAVYU) for DME. Published October 16, 2025. Accessed March 2, 2026. https://www.ophthalmologytimes.com/view/eyepoint-pharmaceuticals-details-phase-3-program-evaluating-vorolanib-intravitreal-insert-duravyu-for-dme