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EyePoint, Inc., a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, announced it 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.
“Completing enrollment across both COMO and CAPRI ahead of expectations is a testament to our team's exceptional execution and dedication to delivering a potentially more durable and differentiated treatment option for patients with DME, the second largest retinal disease market," said Jay S. Duker, M.D., president and chief executive officer of EyePoint. "Duravyu's compelling efficacy and safety profile, combined with positive feedback on our trial design from both the FDA and EMA, underscores our confidence in the program as we advance toward topline data in DME anticipated next year.”
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-naïve 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).
“Today’s milestone represents an important advancement for the retina community, as DME patients remain chronically undertreated given the current frequent and burdensome injection schedule,” said Veeral Sheth, M.D., partner and director of clinical research at University Retina and Macula Associates. “The early and sustained visual and anatomical improvements and encouraging safety profile demonstrated by Duravyu in the phase 2 VERONA trial, alongside the phase 2 DAVIO 2 trial in wet AMD, provide a strong foundation for these phase 3 studies. The rapid enrollment of COMO and CAPRI highlights the excitement in the community to potentially utilize Duravyu’s sustained drug delivery and multi-mechanism of action, which targets inflammation through the inhibition of IL-6/JAK1 signalling alongside the blocking of all VEGF receptors, to provide more durable outcomes for DME patients.”
In May 2026, an independent Data Safety Monitoring Committee (DSMC) convened to review masked safety data from Duravyu’s ongoing phase 3 programmes 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 favourable 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 programme has been developed in alignment with both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Leveraging the established investigator network from the pivotal wet AMD programme, many clinical trial sites from the wet AMD program are participating in the pivotal DME programme, reflecting strong medical community engagement and enthusiasm across the company’s clinical trials and programmes.
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) signalling. 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. As the prevalence of diabetes continues to grow, an increased number of people will be affected by diabetic eye diseases such as DME. The current standard of care for patients experiencing DME includes intravitreal injections of short-acting anti-VEGF biologics, corticosteroids, or laser photocoagulation which can become a burden on patients, caregivers, and physicians due to the longevity of the disease.
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 signalling. 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.
Informed by the robust phase 2, DAVIO trial, which achieved statistically positive and clinically meaningful results vs. on-label aflibercept, the fully enrolled wet AMD phase 3 pivotal programme (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 programme 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 programme 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 favourable safety and tolerability profile with superior dosing intervals to standard of care. Pivotal data from the phase 3 DME programme is anticipated to be reported in the fourth quarter of 2027.
EyePoint, Inc. is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases.
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