First patient dosed in phase 3 LUGANO trial of Duravyu for wet AMD
Click Here to Manage Email Alerts
EyePoint Pharmaceuticals announced that the first patient has been dosed in the global, phase 3 LUGANO clinical trial of Duravyu, formerly EYP-1901, as a treatment for wet age-related macular degeneration, according to a press release.
The company also plans to initiate a second phase 3 trial, LUCIA, by the end of the year.
“The initiation of the LUGANO and LUCIA phase 3 program is a major milestone for retina specialists,” Carl D. Regillo, MD, FACS, FASRS, chief of retina service at Wills Eye Hospital in Philadelphia and clinical trial investigator, told Healio. “EYP-1901 delivers vorolanib, a potent and selective tyrosine kinase inhibitor as a solid bioerodible insert, using the sustained-release Durasert E technology.”
He added, “Vorolanib brings a new mechanistic approach to the treatment of VEGF-mediated retinal diseases as a pan-VEGF receptor inhibitor, inhibiting all VEGF receptors, and has the potential to maintain wet AMD under control for at least 6 months.”
According to the release, both LUGANO and LUCIA trials will enroll about 400 patients with active wet AMD, who will be randomly assigned a 2.7 mg dose of Duravyu or an on-label aflibercept control. Those in the treatment arm will receive an intravitreal injection every 6 months, starting the second month of the trial.
The primary endpoint of both trials is the average change in best corrected visual acuity at weeks 52 and 56 compared with baseline, with secondary endpoints of safety, reduction in treatment burden, percentage of eyes free of supplemental aflibercept injections and OCT-measured anatomical results.
According to the release, Duravyu demonstrated clinically meaningful efficacy data and a favorable safety profile in the phase 1 DAVIO and phase 2 DAVIO 2 trials. In DAVIO 2, more than 80% of patients with wet AMD were free of supplements or had received only one anti-VEGF injection 6 months after treatment with Duravyu.
“Dosing the first patient in the global phase 3 LUGANO trial represents a significant milestone for EyePoint and Duravyu, underscoring our leadership in sustained-release ocular drug delivery and commitment to developing innovative therapies for patients with serious retinal diseases,” Jay S. Duker, MD, the company’s president and CEO, said in the release. “We have entered phase 3 leveraging learnings from our robust DAVIO and DAVIO 2 clinical trials to facilitate accelerated enrollment, so that wet AMD patients may receive this potentially paradigm-shifting treatment as fast as possible.”
Collapse
Read more about
Click Here to Manage Email Alerts