EyePoint Begins Phase 2 VERONA Clinical Trial of EYP-1901 to Treat Diabetic Macular Edema
EyePoint Pharmaceuticals, a company focused on therapeutics for retinal diseases, announced that the first patient has been dosed in the VERONA clinical trial of the company’s EYP-1901 for diabetic macular edema (DME). EYP-1901 is an investigational sustained delivery therapy containing vorolanib, a selective tyrosine kinase inhibitor formulated in bioerodible Durasert E.
Vorolanib is licensed to EyePoint exclusively by Equinox Sciences for the localized treatment of all ophthalmic diseases outside of China, Macao, Hong Kong, and Taiwan.
According to the company, VERONA is a randomized, controlled, single-masked, phase 2 trial of EYP-1901 in DME patients previously treated with a standard-of-care anti-VEGF therapy. The three-arm trial is expected to enroll approximately 25 patients assigned to one of two intravitreal doses of EYP-1901 or an aflibercept control.
The primary efficacy endpoint of the VERONA trial is time to first supplemental aflibercept injection up to 24 weeks based on established supplement criteria. Secondary endpoints include safety, change in best corrected visual acuity, change in central subfield thickness as measured by optical coherence tomography, and change in diabetic retinopathy severity scale over time.
DME, which is the leading cause of vision loss in people with type 1 and type 2 diabetes, results when damaged blood vessels leak fluid into the macula. The resulting retinal swelling can cause blurred vision and may lead to severe vision loss or even blindness.
The current standard of care for patients experiencing DME include 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.
Jay Duker, MD, who is Chief Executive Officer of EyePoint Pharmaceuticals, stated in the company’s press release, “Dosing the first patient in the phase 2 VERONA trial represents another significant milestone in advancing our mission to improve the lives of patients with serious retinal diseases. DME is a common sight-threatening complication of diabetes that can lead to severe vision loss. It represents the second diabetic eye disease indication that we are evaluating for potential treatment using EYP-190.”
Dr. Duker continued, “There is a significant need for differentiated and longer-acting treatments for DME patients, as the current standard of care requires frequent intravitreal injections that are burdensome and can result in under-treatment. We are encouraged by the growing body of clinical data for EYP-1901 and we are optimistic that EYP-1901 has the potential to change the current treatment paradigm for DME with topline data expected in Q1 2025.”
Finally, Dr. Duker advised, “We look forward to announcing additional milestones for the EYP-1901 clinical programs with topline data from the phase 2 PAVIA clinical trial in non-proliferative diabetic retinopathy expected in the second quarter of 2024 and the initiation of the first Phase 3 pivotal trial in wet age-related macular degeneration (wet AMD) anticipated in the second half of 2024.”