EyePoint Initiates DURAVYU Clinical Trials for Diabetic Macular Edema

EyePoint announced the first patient dosed in both Phase 3 COMO and CAPRI global clinical trials of DURAVYU for the treatment of diabetic macular edeme. DURAVYU is an investigational sustained delivery therapy delivering vorolanib, a selective tyrosine kinase inhibitor that brings 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 consists of two global, randomized, double-masked, on-label aflibercept controlled non-inferiority trials assessing the safety and efficacy of DURAVYU in patients with DME, including both treatment-naive and previously treated patients. Each trial will enroll approximately 240 patients, who are randomly assigned, on Day 1, to a DURAVYU 2.7mg dose arm or the aflibercept control arm. Patients in the DURAVYU 2.7mg arm will be re-dosed every six months, starting on Day 1 of the trial. DURAVYU 2.7mg is delivered via a single standard intravitreal injection in the physician's office, similar to current standard practice with FDA approved intravitreal treatments. The primary endpoint is a non-inferior change from baseline in best corrected visual acuity 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. The DME pivotal program was informed by a positive End of Phase 2 meeting with the U.S. Food and Drug Administration and has alignment with both the FDA and the European Medicines Agency.