EyePoint reports positive interim safety data for diabetic retinopathy, wet AMD treatment
EyePoint Pharmaceuticals has announced positive interim masked safety data for its investigational EYP-1901 for treatment of moderate to severe nonproliferative diabetic retinopathy and wet age-related macular degeneration.
According to a company press release, EYP-1901 combines EyePoint’s proprietary sustained delivery technology and vorolanib, a tyrosine kinase inhibitor. The investigational product is currently being evaluated as a 9-month treatment for nonproliferative diabetic retinopathy (NPDR) in the phase 2 PAVIO trial and as a 6-month treatment for wet AMD in the phase 2 DAVIO 2 trial, both of which are ongoing.
“We remain very encouraged by the positive masked safety results that EYP-1901 has produced to date in the 17 patients dosed in the phase 1 DAVIO trial in wet AMD, as well as approximately 150 additional patients in our two phase 2 clinical trials: DAVIO 2 and PAVIA,” Jay S. Duker, MD, EyePoint president and CEO, said in the release. “These results bolster our confidence in EYP-1901 as a potentially paradigm-shifting treatment for patients who would benefit from a safe, sustained therapeutic option for VEGF-mediated diseases.”
The 12-month PAVIA trial enrolled 77 patients with moderate to severe NPDR, who were randomized to receive 2 mg or 3 mg EYP-1901, delivered via a single intravitreal injection, or placebo. According to the release, no drug-related ocular severe adverse events or drug-related systemic severe adverse events have been reported after a minimum of 3 months of post-injection follow-up.
The DAVIO 2 trial enrolled patients who previously had been treated for wet AMD with anti-VEGF therapy and assigned them to 2 mg or 3 mg EYP-1901 or an aflibercept control. The interim safety data for this trial are comparable to that of the completed phase 1 DAVIO trial, which demonstrated a positive safety profile with no reported drug-related or ocular severe adverse events.
“We remain on track to share our topline results from the DAVIO 2 trial in December of this year and from the PAVIA trial in the second quarter of 2024,” Duker said in the release.