EyePoint Pharmaceuticals Announces Two Presentations of Topline Data with Additional Subgroup Analyses from the Phase 2 DAVIO 2 Clinical Trial of EYP-1901 for the Treatment of Wet Age-Related Macular Degeneration - Seite 2

A second presentation also included the previously reported positive topline results of its Phase 2 DAVIO 2 trial of EYP-1901. The 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 an approximately 85% mean reduction in historical treatment burden, nearly two-thirds of eyes supplement-free up to six months and over 83% receiving only zero or one supplement up to six-months. Additionally, there was strong anatomical control in both EYP-1901 cohorts as measured by optical coherence tomography (OCT).

DAVIO 2 is a randomized, controlled Phase 2 clinical trial of EYP-1901 in previously treated patients with wet AMD. Originally designed to enroll 144 patients, the trial enrolled 160 patients in total due to strong investigator and patient interest. All enrolled patients were previously treated with a standard-of-care anti-VEGF therapy and were 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 standard intravitreal injection in the physician’s office, similar to current FDA approved anti-VEGF treatments. The primary non-inferiority efficacy endpoint is change in BCVA compared to the aflibercept control, approximately six-months after the EYP-1901 injection. Secondary endpoints include safety, change in CST as measured by OCT, the number of eyes that remain free of supplemental anti-VEGF injections, and number of aflibercept injections in each group. More information about the trial is available at clinicaltrials.gov (identifier: NCT05381948).

Phase 2 DAVIO 2 12-month results and the initiation of a Phase 3 trial in wet AMD are both expected in the second half of 2024. The Company remains on track to report additional clinical milestones with EYP-1901 this year with the readout of topline data from the Phase 2 PAVIA trial in non-proliferative diabetic retinopathy (NPDR) anticipated in the second quarter of 2024.

About Wet AMD

Age-related macular degeneration (AMD) is a leading cause of vision loss and irreversible blindness in people over the age of 60. Wet AMD is an advanced form of the condition that develops when abnormal blood vessels grow into the macular retina, leaking blood or fluid, and leading to potentially rapid and severe vision loss. Wet AMD is a lifelong disease that requires continuous treatment so that patients may maintain visual function. Although multiple treatments are now available, challenges still exist as the current standard-of-care is dosed on average every two months in the United States under a treat-and-extend protocol, and these large molecule anti-VEGF treatments only target one pathology of the disease. This lifetime of frequent treatment represents a tremendous burden for patients, physicians, and the health care system, potentially leading to patient noncompliance and further vision loss.