The firm is gathering safety and efficacy evidence for its sustained delivery, selective tyrosine kinase inhibitor nAMD treatment.
EyePoint Pharmaceuticals (Massachusetts, USA) announced the dosing of the first patient in LUCIA, its second global Phase 3 clinical trial of DURAVYU™ for the treatment of wet, or neovascular, age-related macular degeneration (nAMD).
This announcement follows closely on the progress of the LUGANO trial, the company’s first pivotal Phase 3 clinical trial for the same therapy.
“Dosing the first patient in our second global Phase 3 clinical trial, the LUCIA trial, marks another significant milestone demonstrating our continued focus on execution at EyePoint,” said EyePoint Pharmaceuticals CEO and President Dr. Jay Duker in a press release.
DURAVYU, formerly EYP-1901, is a sustained delivery therapy using vorolanib, a selective tyrosine kinase inhibitor, in EyePoint’s proprietary bioerodible Durasert E™ platform for long-term intraocular delivery.
According to Dr. Adam Gerstenblith, principal investigator in the LUCIA clinical trial and vitreoretinal surgeon at Mid Atlantic Retina Specialists, DURAVYU seeks to fill major unmet needs in the current standard-of-care in nAMD treatment.
“Patients with wet AMD typically require life-long treatment with frequent intravitreal injections to preserve their vision. This high treatment burden often results in under-treatment and irreversible vision loss,” he said.
“The Phase 3 LUCIA trial is an important step forward in our pursuit of more durable treatments that are safe and effective. Moreover, the design of the LUCIA trial includes both treatment naïve and previously treated wet AMD patients, as well as re-dosing of DURAVYU every six months, which aligns well with how we would approach potential treatment using DURAVYU in clinical practice.”
DURAVYU gains momentum
The company has also noted a higher-than-expected interest in enrollment in DURAVYU.
“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,” said Dr. Duker.
“With two simultaneous Phase 3 clinical trials underway, the most robust clinical dataset of all long-acting treatments in development for nAMD, 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.”
Combined with a strong financial foundation, these advancements position DURAVYU as what the company describes as a leading solution in sustained-release ocular drug delivery for serious retinal diseases.
The Phase 3 pivotal program represents the first sustained-release nAMD clinical trials specifically designed to evaluate re-dosing across both studies. Utilizing a non-inferiority approval pathway, the LUGANO and LUCIA trials aim to generate comprehensive data on the efficacy, durability, safety, and dosing flexibility of DURAVYU.
Goals and design of the Phase 3 trials
The LUGANO and LUCIA trials are pivotal Phase 3 programs designed to evaluate the efficacy and safety of DURAVYU in sustained-release nAMD treatments. The trial also aims to evaluate re-dosing in the drug—a first in the field. These trials follow a non-inferiority approval pathway and aim to generate critical data on DURAVYU’s efficacy, durability, safety, and dosing flexibility.
Both trials are global, randomized, double-masked, and aflibercept-controlled. Each trial plans to enroll approximately 400 patients with active nAMD, including both treatment-naïve and treatment-experienced individuals. Patients assigned to the DURAVYU group will receive 2.7mg doses via intravitreal injection every six months, starting at month two.
The primary endpoint is the change in best corrected visual acuity (BCVA) at weeks 52 and 56 compared to baseline. Secondary endpoints include safety, reduction in treatment burden, percentage of eyes free from supplemental aflibercept injections, and anatomical results measured via optical coherence tomography (OCT).
These trials are poised to offer valuable insights into how DURAVYU could be integrated into real-world clinical practice. With over 240 global sites committed and strong enthusiasm from both patients and investigators, the program is well-positioned to achieve rapid enrollment.
Topline data for the Phase 3 pivotal program are expected in 2026.