EyePoint Pharmaceuticals has concluded subject enrolment in the pivotal Phase III programme assessing Duravyu, aimed at treating wet age-related macular degeneration (wet AMD).
LUCIA is the second of two non-inferiority trials and has completed full enrolment. This follows enrolling participants in the first study, LUGANO, in May 2025.
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More than 400 subjects were enrolled and randomised in LUCIA during a seven-month period.
Based on interim masked safety outcomes, EyePoint has reported that the LUGANO and LUCIA trials’ safety profile aligns with earlier clinical findings.
EyePoint has confirmed that the safety profile of the therapy, assessed in more than 190 subjects across four studies, showed no serious adverse events related to systemic or ocular conditions.
An independent Data Safety Monitoring Committee has also reviewed the data and recommended the continuation of the programme.
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By GlobalDataThe company anticipates releasing topline data soon after the outcomes from LUGANO are released, which are anticipated in mid-2026.
The randomised, double-masked LUGANO and LUCIA studies are supported by the safety and efficacy data from the DAVIO 2 Phase II study.
These trials are designed to assess the therapy’s safety and efficacy in treating subjects with active wet AMD, including those who are treatment naïve and treatment experienced.
Subjects will be randomised and given either 2.7mg of Duravyu or an on-label aflibercept control.
The trials are assessing a six-month redosing schedule over two years. The primary endpoint is the average change in best corrected visual acuity (BCVA) at weeks 52 and 56, compared to the baseline.
Those who are in the 2.7mg arm of the therapy will be given an intravitreal dose every six months, beginning at month two of the study.
EyePoint Pharmaceuticals CEO and president Jay Duker said: “The industry-leading pace of our clinical programme is a testament to the patient and physician enthusiasm for innovative, novel, and more durable wet AMD treatments and Duravyu’s compelling and differentiated profile.
“As we look ahead to anticipated topline data for LUGANO in mid-2026 and LUCIA to follow, we remain focused on bringing the first sustained-release TKI for wet AMD to market and advancing our mission of delivering transformative treatment options for patients.”
Duravyu (EYP-1901) is designed for sustained delivery to treat vascular endothelial growth factor (VEGF)-mediated retinal conditions.
Last year, EyePoint began the Phase II VERONA trial of EYP-1901, targeting diabetic macular oedema.
