EyePoint has begun dosing in two global Phase 3 trials, COMO and CAPRI, evaluating DURAVYU (vorolanib intravitreal insert) in diabetic macular edema. Each randomized, double-masked non-inferiority study will enroll about 240 patients across treatment-naïve and previously treated cohorts, comparing fixed six-month DURAVYU re-dosing to on-label aflibercept. The primary endpoint is change in best corrected visual acuity at weeks 52 and 56 (blended), with secondary measures including safety, reduction in treatment burden, proportion of eyes free of supplemental aflibercept, and OCT-based anatomy. Topline DME results are targeted for the second half of 2027. In parallel, EyePoint’s wet AMD program (LUGANO and LUCIA) is fully enrolled with more than 900 patients and first readouts expected beginning mid-2026.
Strategically, EyePoint is executing a dual-indication pivotal plan to position a sustained-release tyrosine kinase inhibitor as a durability-forward alternative to frequent anti-VEGF injections. The choice of an on-label aflibercept control and a non-inferiority endpoint is a conventional regulatory path built to secure a broad label while foregrounding a six-month fixed dosing claim. The company is leaning on Phase 2 signals in DME (VERONA) and wet AMD (DAVIO/DAVIO 2) that suggested sustained visual and anatomic control without emergent safety signals in fewer than 200 patients, while differentiating mechanistically via intracellular inhibition of all VEGF receptors, PDGFR, and IL-6/JAK1–mediated inflammation. The bet is that a small-molecule insert delivered by a standard intravitreal injection can capture the durability narrative without the procedural complexity, refill logistics, or immunogenicity concerns that have constrained some long-acting biologic and implant approaches.
For sites and CROs, the operational footprint is familiar: office-based intravitreal administration, fixed six-month re-dosing, and intensive OCT and BCVA assessments to support rescue criteria. The masking strategy is straightforward given identical injection procedures, but execution hinges on rigor around supplemental aflibercept triggers to preserve interpretability of treatment-burden endpoints. Visit cadence may shift from high-frequency injections to more assessment-heavy follow-up, affecting chair-time planning, imaging throughput, and drug accountability workflows. Global enrollment could compete with real-world extension and outcomes studies for faricimab and high-dose aflibercept, so retina networks with established DME pipelines will be central to timelines.
Regulatory alignment with FDA and EMA and the use of standard-of-care comparators de-risk the filing path if non-inferiority is met. Market adoption, however, will likely depend on quantifying injection-free intervals and rescue rates alongside consistent OCT control. Safety will be a focal point at Phase 3 scale, including intraocular inflammation, IOP elevations, endophthalmitis rates, and any polymer-related events. On the CMC side, bioerodible insert manufacturing, sterile fill-finish capacity, and quality system readiness remain gating factors as programs advance in parallel across two high-prevalence retinal indications.
Near-term, the wet AMD readout in mid-2026 will set expectations for DME by clarifying BCVA trajectories, durability, rescue utilization, and ocular safety with six-month dosing. In DME, watch how the protocol defines supplemental injection thresholds, the proportion of eyes remaining injection-free through six and twelve months, and whether secondary analyses establish superiority on treatment burden. Competitive pressure continues as biologics extend dosing intervals; to secure clinical and commercial space, DURAVYU will need to pair non-inferior vision outcomes with materially fewer interventions and a clean safety profile. If achieved, site adoption should be straightforward given procedural familiarity; if margins are narrow, the window could compress as incumbents consolidate longer-interval treatment in routine practice.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
