EyePoint Pharmaceuticals Reports Positive 30-Day Safety Results for All Cohorts From DAVIO Trial of EYP-1901 for Wet AMD

EyePoint Pharmaceuticals announced positive safety results from its phase 1 clinical trial of EYP-1901, a potential twice-yearly sustained delivery anti-VEGF treatment targeting wet age-related macular degeneration (AMD). All dose cohorts have reached at least 30-day post-dosing follow up.

“We are pleased by the 30-day safety data seen for all three cohorts of the EYP-1901 DAVIO trial in patients with wet AMD,” Nancy Lurker, CEO of EyePoint Pharmaceuticals, said in a company news release. “These early results continue to support our belief in the potential of EYP-1901 to be a safe and effective therapeutic for long-term treatment of wet AMD. We are looking forward to releasing interim efficacy results once we have sufficient follow-up data for all dose cohorts in the fourth quarter of this year. Additionally, we continue to progress toward initiating our clinical trials of EYP-1901 for diabetic retinopathy and retinal vein occlusion.”

The DAVIO clinical trial of EYP-1901 enrolled 17 wet AMD patients across three dose cohorts. Key safety observations through at least 30-Day post-dosing follow-up for all patients include:

• No serious adverse events (SAEs), ocular or systemic, were reported
• The three subjects in cohort 1 have been followed for a minimum of 4 months with no reported SAE’s
• To date, there are no reported adverse events (AEs) related to significant intraocular inflammation, best-corrected visual acuity (BCVA) reduction, or elevation of intraocular pressure (IOP)
• No events of endophthalmitis, retinal detachment or migration into the anterior chamber have been reported to date

The patients enrolled in the phase 1 DAVIO open-label, dose escalation trial were previously treated with standard of care anti-VEGF therapies. EYP-1901 is delivered via a single intravitreal injection in the physician’s office. The primary endpoint of the trial is safety, and key secondary endpoints are best corrected visual acuity (BCVA) and central subfield thickness (CST) as measured by optical coherence tomography (OCT).

EYP-1901 utilizes the company’s proprietary Durasert drug delivery technology that has been used in four FDA-approved products, including EyePoint’s Yutiq for chronic noninfectious uveitis affecting the posterior segment of the eye.

About EYP-1901

EYP-1901 is a potential twice-yearly sustained delivery intravitreal anti-VEGF treatment for wet age-related macular degeneration. EYP-1901 combines a bioerodible formulation of EyePoint’s proprietary Durasert sustained release technology with vorolanib, a tyrosine kinase inhibitor. Vorolanib provided clear efficacy signals in two prior human trials in wet AMD as an orally delivered therapy with no significant ocular adverse events. Preclinical studies of EYP-1901 have shown anti-VEGF activity in disease models of ocular neovascularization and no serious safety issues were observed. EYP-1901 is initially being developed as a treatment of wet AMD, with the potential for additional indications in diabetic retinopathy and retinal vein occlusion.