First patient dosed in Phase I clinical trial of wet AMD treatment candidate

January 28, 2021
David Hutton

The Phase 1 clinical trial of EyePoint Pharmaceuticals Inc.’s EYP-1901 is underway. It is a potential twice-yearly sustained delivery anti-VEGF treatment targeting wet age-related macular degeneration.

EyePoint Pharmaceuticals Inc. announced that the first patient has been dosed in the Phase 1 clinical trial of EYP-1901 as a potential twice-yearly sustained delivery anti-VEGF treatment targeting wet age-related macular degeneration (wet AMD).

According to a release, EYP-1901 leverages EyePoint’s Durasert drug delivery technology that has been used in four FDA-approved products, including EyePoint’s Yutiq for chronic non-infectious uveitis affecting the posterior segment of the eye.

EYP-1901 uses a bioerodible Durasert formulation combined with a clinically validated anti-VEGF molecule, vorolanib. In oral formulation, vorolanib demonstrated efficacy and ocular safety through Phase 2 trials in wet AMD. In addition to wet AMD, EYP-1901 is anticipated to be studied for the potential treatment of diabetic retinopathy and retinal vein occlusion in future clinical trials.

The Phase 1 DAVIO open-label, dose escalation trial, will examine thirteen wet AMD patients who were responsive to previous anti-VEGF treatments. EYP-1901 will be 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.

Based on clinical outcomes during the initial dose escalation phase, there is a potential to expand the trial.

Nancy Lurker, president and chief executive officer, EyePoint Pharmaceuticals, noted that EYP-1901 represents a promising new approach for treating wet AMD, a disease that despite the availability of current anti-VEGF therapies continues to progressively impair vision in millions of patients.

“Current approved treatments are effective, but they require monthly or bi-monthly eye injections in a physician’s office, which can cause inconvenience and discomfort and often lead to reduced compliance and poor outcomes,” she said in a statement. “The sustained release, intravitreal anti-VEGF formulation of EYP-1901 has the potential to become the first treatment for wet AMD with twice yearly dosing.”

“The potential efficacy of vorolanib coupled with the well-characterized safety and predictable drug release kinetics of the Durasert delivery technology offer the potential to provide millions of wet AMD sufferers a convenient and effective treatment option, if approved,” Jay S. Duker, MD, chief strategic scientific officer at EyePoint Pharmaceuticals and chairman of Ophthalmology at Tufts Medical Center and Tufts University School of Medicine, said in a statement. “We are excited to have this trial underway and are looking forward to seeing initial data as early as the second half of this year.”