The company announced key secondary endpoints were achieved with both EYP-1901 doses. These include a more than 80% reduction in treatment burden, with nearly two-thirds of eyes supplement-free up to 6 months.
EyePoint Pharmaceuticals Inc announced positive topline results of its Phase 2 DAVIO 2 trial of EYP-1901, an investigational sustained delivery maintenance treatment for wet age-related macular degeneration (wet AMD) combining vorolanib, a selective tyrosine kinase inhibitor with bioerodible Durasert E.
According to the company’s news release,1 the clinical trial met its primary endpoint with both EYP-1901 doses demonstrating statistical non-inferiority change in best corrected visual acuity (BCVA) compared to aflibercept control and a favorable safety profile with no EYP-1901-related ocular or systemic serious adverse events (SAEs).
The trial also achieved key secondary endpoints with both EYP-1901 doses, including a more than 80% reduction in treatment burden, nearly two-thirds of eyes supplement-free up to 6 months, and over 80% receiving only zero or one supplement up to 6 months.
Moreover, the company reported strong anatomical control with both EYP-1901 cohorts as measured by optical coherence tomography (OCT).1
Jay S Duker, MD, president and CEO of EyePoint Pharmaceuticals, pointed out the company was pleased with the Phase 2 results which he said underscore EYP-1901’s potential as a paradigm-altering maintenance treatment for patients with wet AMD, with a positive safety profile.
“Since EYP-1901 achieved statistical non-inferiority to the aflibercept control in this trial there is potential for meaningfully lower sized and lower cost pivotal Phase 3 trials,” Duker said in the news release.
Duker also lauded the patients and investigators who participated in the DAVIO 2 trial as well as the company’s employees who helped advance EyePoint’s efforts.
“The DAVIO 2 clinical trial was designed to support the initiation of Phase 3 clinical trials based on feedback received from the US Food and Drug Administration (FDA) at a Type C meeting last year,” Duker added in the news release. “The 32-week topline DAVIO 2 data strongly supports our planned Phase 3 non-inferiority design, consistent with the FDA’s recent guidance for wet AMD clinical trials. We look forward to continuing our dialogue regarding our Phase 3 plans with the FDA as we prepare to initiate our first pivotal trial for wet AMD in the second half of 2024.”
“These highly positive Phase 2 results are the result of years of hard work by the dedicated EyePoint team coupled with our proven Durasert technology which continues to demonstrate the benefit of zero order kinetics drug delivery. I look forward to initiation of Phase 3 and potentially bringing this innovative and much needed new drug to market for patients suffering from these blinding eye diseases,” Nancy Lurker, executive vice chairwoman of EyePoint Pharmaceuticals. “I want to congratulate the EyePoint team on the continued execution of this program.”