EyePoint Pharmaceuticals recently reported that EYP-1901, the company’s investigational treatment for neovascular age-related macular degeneration (wet AMD), met all primary endpoints in the DAVIO 2 clinical trial. Both 2 mg and 3 mg doses of EYP-1901 demonstrated statistical noninferiority to aflibercept, as measured by change in best-corrected visual acuity (BCVA) over 32 weeks, as well as a favorable safety profile.
Top-line data from the phase 2 DAVIO 2 trial, which enrolled 166 patients, showed that both EYP-1901 doses also achieved key secondary endpoints, including 89% and 85% reduction in treatment burden, respectively, for the 2-mg and 3-mg doses. At both doses, nearly two-thirds of eyes were supplement-free up to 6 months. EYP-1901 is a bioerodible Durasert E insert, placed with a single intravitreal injection, that provides sustained-release delivery of vorolanib, a selective tyrosine kinase inhibitor.
“I am very encouraged by the data … showing essentially no difference in visual outcome at the blended 6-month endpoint from a single injection of EYP-1901 compared to on-label, bimonthly aflibercept injections,” Carl Regillo, MD, chief of the Retina Service at Wills Eye Hospital in Philadelphia, said in a news release. “I believe that EYP-1901 could be a paradigm shift in how patients with wet AMD are treated.”
EyePoint president and CEO Jay S. Duker, MD, said that the DAVIO 2 data support advancement to a phase 3 pivotal trial, which the company expects to begin in the second half of 2024. EYP-1901 is also being studied as a treatment for nonproliferative diabetic retinopathy (NPDR) and diabetic macular edema (DME).