EyePoint Pharmaceuticals, Inc., a pharmaceutical company committed to developing and commercializing therapeutics to improve the lives of patients with serious eye disorders, has announced that the first patient has been dosed in the Phase 2 "Durasert® and Vorolanib in Ophthalmology 2" (DAVIO 2) clinical trial of EYP-1901, an investigational sustained delivery anti-vascular endothelial growth factor (anti-VEGF) treatment for wet age-related macular degeneration (wet AMD).
"We are very pleased to announce the initiation of the Phase 2 DAVIO 2 clinical trial of EYP-1901 for wet AMD. Using a 'Treat to Maintain' therapeutic approach, EYP-1901 has the potential to transform the wet AMD treatment landscape by sustaining a majority of patients up to six months without supplemental anti-VEGF treatment, thereby greatly reducing the treatment burden," said Nancy Lurker, Chief Executive Officer of EyePoint Pharmaceuticals. "We are encouraged by the safety and efficacy results from our Phase 1 DAVIO trial, including no reports of ocular or drug related systemic serious adverse events and strong durability data with 53% of patients requiring no supplemental treatment up to six months. We anticipate initial topline data from our Phase 2 trial in the second half of 2023."
The twelve-month, randomized, controlled Phase 2 DAVIO 2 trial of EYP-1901 for wet AMD is expected to enroll approximately 150 patients, previously treated with a standard-of-care anti-VEGF therapy, randomly assigned to one of two doses of EYP-1901 (approximately 2 mg or 3 mg) or an aflibercept control. EYP-1901 is delivered with a single intravitreal injection in the physician's office, similar to current FDA approved anti-VEGF treatments. The primary efficacy endpoint of the DAVIO 2 trial is change in best corrected visual acuity (BCVA) compared to the aflibercept control six-months after the EYP-1901 injection. Secondary efficacy endpoints include change in central subfield thickness (CST) as measured by optical coherence tomography (OCT), time to first supplemental anti-VEGF, and safety. More information about the trial is available at clinicaltrials.gov (identifier: NCT05381948).
About EYP-1901
EYP-1901 is being developed as an investigational sustained delivery treatment combining a bioerodible formulation of EyePoint's proprietary Durasert® delivery technology with vorolanib, a tyrosine kinase inhibitor. Positive twelve-month safety and efficacy data from the DAVIO Phase 1 clinical trial of EYP-1901 showed no reports of ocular or drug-related systemic serious adverse events and no dose limiting toxicities with stable visual acuity and OCT. Further, 53% and 35% of eyes did not require supplemental anti-VEGF injections up to six and twelve months, respectively, following a single dose of EYP-1901. Phase 2 clinical trials are underway for wet AMD and planned in non-proliferative diabetic retinopathy in Q3 2022 and diabetic macular edema in 2023. Vorolanib is licensed to EyePoint exclusively by Equinox Sciences for the localized treatment of all ophthalmic diseases.
Read the full press release from EyePoint Pharmaceuticals.
Source: EyePoint Pharmaceuticals