EyePoint Pharmaceuticals Doses First Patient in Phase 3 LUGANO Trial for Wet AMD Therapy Duravyu

EyePoint Pharmaceuticals announced dosing of the first patient in its phase 3 LUGANO clinical trial of Duravyu. This investigational sustained delivery therapy, formerly known as EYP-1901, aims to treat wet age-related macular degeneration (AMD) using a patent-protected formulation of vorolanib, a selective tyrosine kinase inhibitor, delivered through the company’s proprietary bioerodible Durasert E technology.

“Dosing the first patient in the global phase 3 LUGANO trial marks a pivotal milestone for EyePoint and Duravyu, underscoring our leadership in sustained-release ocular drug delivery and our commitment to addressing the needs of patients with serious retinal diseases,” Jay S. Duker, MD, President and CEO of EyePoint, said in a company news release. “We have designed the LUGANO and LUCIA trials for potential global regulatory success, following the noninferiority approval pathway we’ve established in alignment with the FDA. Our aim is to accelerate the delivery of this paradigm-shifting treatment to wet AMD patients as quickly as possible.”

The LUGANO trial, along with the upcoming LUCIA trial, will evaluate the efficacy and safety of Duravyu. With over 150 clinical trial sites committed, EyePoint expects to rapidly enroll approximately 400 patients globally. The trials are designed to include both treatment-naïve and treatment-experienced patients to more accurately represent real-world wet AMD populations.

Patients in the trial will receive Duravyu every 6 months, while those in the control group will receive on-label aflibercept injections every 2 months, following three initial loading doses. The primary efficacy endpoint will be the average change in best corrected visual acuity (BCVA) at 52 and 56 weeks, with secondary measures including safety, treatment burden, and anatomical outcomes.

“The data from the DAVIO and DAVIO 2 trials suggest that Duravyu has the potential to maintain disease control without the need for supplemental anti-VEGF therapy for 6 months or longer, offering a significant improvement in treatment burden and vision outcomes," said Carl Regillo, MD, Director of Retina Service at Wills Eye Hospital.