공시 • Mar 03
Eyepoint Announces First Patients Dosed in Both Global Phase 3 Clinical Trials of Duravyu™ for the Treatment of Diabetic Macular Edema
EyePoint, Inc. announced the first patient dosed in both Phase 3 COMO and CAPRI global clinical trials of 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) 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 (COMO and CAPRI) assessing the safety and efficacy of DURAVYU in patients with DME, including both treatment-naïve 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 (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). The DME pivotal program was informed by a positive End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) and has alignment with both the FDA and the European Medicines Agency (EMA). 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. DME is driven by VEGF and PDGF production and inflammation associated with interleukin-6 (IL-6) signaling. This resulting retinal swelling can cause blurred vision and may lead to severe vision loss or even 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 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. 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 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 program are anticipated to be reported beginning in mid-2026.DURAVYU is also being evaluated for the treatment of DME, with both Phase 3 trials (COMO and CAPRI) underway and actively recruiting patients. 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. Data from the Phase 3 program is anticipated to be reported in the second half of 2027.