Patient dosing begins in phase 2 clinical trial for wet AMD treatment
The first patient has been dosed in the phase 2 DAVIO 2 clinical trial assessing EYP-1901 for the treatment of wet age-related macular degeneration, according to a press release from EyePoint Pharmaceuticals.
The 12-month randomized controlled trial will enroll approximately 150 patients with wet AMD previously treated with a standard-of-care anti-VEGF therapy. They will be randomly assigned to receive either one of two doses of EYP-1901, approximately 2 mg or 3 mg, or an aflibercept control.
Change in best corrected visual acuity, the primary efficacy endpoint, will be compared with aflibercept control at 6 months after the EYP-1901 injection; change in central subfield thickness, time to first supplemental anti-VEGF injection and safety are the secondary efficacy endpoints.
“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 6 months without supplemental anti-VEGF treatment, thereby greatly reducing the treatment burden,” Nancy Lurker, CEO of EyePoint, said in the release. “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 6 months.”
Topline data are expected in the second half of 2023.
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