お知らせ • Jul 30
Eyepoint Completes Enrollment of Both Pivotal Phase 3 Trials of Duravyu for Treatment of Diabetic Macular Edema
EyePoint, Inc. has completed enrollment in COMO and CAPRI, the two global Phase 3 clinical trials of DURAVYU (vorolanib intravitreal insert) for the treatment of diabetic macular edema (DME). Over 480 patients have been enrolled across both trials, with full enrollment occurring ahead of schedule, in only five months. Topline data for both DME trials are anticipated in the Fourth Quarter of 2027. COMO and CAPRI are global, randomized, double-masked, on-label 2mg aflibercept controlled non-inferiority Phase 3 trials assessing the safety and efficacy of DURAVYU in DME, and include both treatment-naive and previously treated patients. Patients are randomized on Day 1 to a DURAVYU 2.7mg dose arm or the aflibercept control arm. Patients in the DURAVYU arm will be re-dosed every six months. DURAVYU is delivered via a single standard intravitreal injection in the physician's office, similar to current FDA approved intravitreal treatments. The primary endpoint is a non-inferior change from baseline in best corrected visual acuity (BCVA) to weeks 52 and 56, blended, compared to on-label 2mg 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). An independent Data Safety Monitoring Committee (DSMC) convened to review masked safety data from DURAVYU's ongoing Phase 3 programs in wet age-related macular degeneration (wet AMD) and DME. Upon completion of its review, the DSMC recommended continuation of both programs as planned, with no protocol modifications. DURAVYU has been evaluated in over 190 patients across four completed clinical trials, demonstrating a favorable safety and tolerability profile including no observed DURAVYU-related safety concerns. The pivotal Phase 3 COMO and CAPRI trials were informed by the safety and efficacy findings from the VERONA Phase 2 clinical trial in which DURAVYU 2.7mg demonstrated an early and sustained improvement in BCVA, reduction in treatment burden of two-thirds, extended time to first supplemental injection versus aflibercept control, and anatomical improvements in central subfield thickness (CST). The Phase 3 program has been developed in alignment with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Leveraging the established investigator network from the pivotal wet AMD program, many clinical trial sites from the wet AMD program are participating in the pivotal DME program. Diabetic macular edema (DME) is the leading cause of vision loss in people with type 1 and type 2 diabetes. DME results when damaged blood vessels leak fluid into the macula, the central portion of the retina responsible for the sharp vision needed for routine tasks such as driving or reading. Evidence suggests DME is driven by not only VEGF, but also PDGF production as well as inflammation associated with interleukin-6 (IL-6) signaling. The resulting retinal swelling can cause blurred vision and may lead to severe vision loss or even legal blindness. DME is a common form of sight-threatening retinopathy in people with diabetes, with approximately 28 million people afflicted worldwide. The current standard of care for patients experiencing DME includes intravitreal injections of short-acting anti-VEGF biologics, corticosteroids, or laser photocoagulation. DURAVYU (vorolanib intravitreal insert), is an investigational sustained-delivery treatment for patients suffering from serious retinal diseases. DURAVYU combines vorolanib, a selective and patent-protected tyrosine kinase inhibitor (TKI), in next-generation bioerodible Durasert E, a proprietary and best-in-class IVT delivery technology designed to provide sustained release of drug for at least six months without free-floating drug particles. DURAVYU brings a potential new multi-mechanism of action and treatment paradigm for retinal diseases beyond existing anti-VEGF large molecule ligand blocking therapies, as vorolanib acts intracellularly to suppress angiogenesis through the inhibition of all VEGF receptors and PDGFR, while also suppressing inflammation through the inhibition of interleukin 6 (IL-6)/JAK1 signaling. In addition to the safety and efficacy demonstrated in the DAVIO, DAVIO 2 and VERONA clinical trials, vorolanib has also demonstrated neuroprotection in an in-vivo model of retinal detachment. DURAVYU has established safety and efficacy data from both Phase 1 and 2 trials in wet AMD and DME that demonstrate stability in vision and anatomical control with a single dose of DURAVYU. No safety signals were observed in over 190 patients across four completed clinical trials, including three Phase 2 trials. The fully enrolled wet AMD Phase 3 pivotal program (LUGANO and LUCIA) is the only investigational program evaluating every six-month dosing of DURAVYU, which enables the potential to support a compelling competitive label and advantage for DURAVYU. With over 900 patients randomized across both trials, the Phase 3 pivotal program follows a well-established regulatory approval pathway with a patient-centric noninferiority design comparing DURAVYU to on-label standard of care to inform real-word treatment practices. Data from the Phase 3 wet AMD program are anticipated to be reported beginning in August 2026. DURAVYU is also being evaluated for the treatment of DME, with both Phase 3 trials (COMO and CAPRI) fully enrolled and underway. The Phase 2 VERONA trial in DME met primary and secondary endpoints and demonstrated a rapid and sustained improvement in vision and anatomy and a continued favorable safety and tolerability profile with superior dosing intervals to standard of care. Pivotal data from the Phase 3 DME program is anticipated to be reported in the Fourth Quarter of 2027. Vorolanib is licensed to EyePoint exclusively by Equinox Sciences, a Betta Pharmaceuticals affiliate, for the localized treatment of all ophthalmic diseases outside of China, Macao, Hong Kong and Taiwan. DURAVYU has been conditionally accepted by the FDA as the proprietary name for EYP-1901. DURAVYU is an investigational product; it has not been approved by the FDA.