Patient dosing underway in phase 3 LUCIA trial of Duravyu for wet AMD

The first patient underwent dosing in the phase 3 LUCIA clinical trial of Duravyu for wet age-related macular degeneration, according to a press release from EyePoint Pharmaceuticals.

The LUCIA trial comes on the heels of the phase 3 LUGANO trial, which began dosing in October. Both are aflibercept-controlled noninferiority trials to assess the safety and efficacy of Duravyu, a sustained-release intravitreal insert that delivers vorolanib, in patients with wet AMD, according to the release.

In each trial, approximately 400 patients will receive either a 2.7 mg dose of Duravyu or on-label aflibercept control. Patients in the Duravyu arms will receive an intravitreal injection of Duravyu every 6 months starting at month 2, according to the release.

The primary endpoint of the trials is the average change in best corrected visual acuity at weeks 52 and 56 compared with baseline.

“We are encouraged by the robust physician and patient interest in Duravyu with enrollment in our first pivotal trial, the LUGANO trial, exceeding our expectations,” EyePoint president and CEO Jay S. Duker, MD, said in the release. “With two simultaneous phase 3 clinical trials underway, the most robust clinical dataset of all long-acting treatments in development for wet AMD and a strong balance sheet, we are well positioned as the leader in sustained-release ocular drug delivery bringing impactful therapies to patients suffering from serious retinal diseases.”

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