Texas Retina Associates Director of Clinical Research for Dallas Ashkan Abbey, MD, recently dosed the first patient in the Phase III LUGANO clinical trial of Duravyu (formerly EYP-1901) for the treatment of wet age-related macular degeneration (AMD). Duravyu is an investigational sustained delivery maintenance treatment for wet AMD that combines vorolanib, a selective tyrosine kinase (anti-VEGF) inhibitor, with bioerodible Durasert E™.
Challenges in Treating Wet AMD
Age-related macular degeneration (AMD) is a leading cause of vision loss in people over the age of 50. It happens when the macula, the central part of the retina responsible for detailed vision tasks, is damaged. Wet AMD is an advanced form of the the condition where abnormal blood vessels grow into the macular retina, leaking blood or fluid, and leading to potentially severe vision loss. It is a lifelong disease that requires continuous treatment so that patients may maintain visual function.
Although multiple treatments for wet AMD are now available, challenges still exist. Current standard-of-care anti-VEGF injections must be dosed on average every two months, which can create a treatment burden for some patients. Delayed or missed appointments can potentially leave patients with no active drug to prevent disease progression and associated vision loss.
“Despite new treatments entering the wet AMD market, there remains a need for safe and durable treatments that provide sustained treatment while decreasing the patient’s need for frequent injections,” explains Dr. Abbey. “Duravyu brings a new mechanism of action with the potential to treat wet AMD patients every six months or longer to actively safeguard patients’ vision between visits.”
About the LUGANO Trial
LUGANO is global, randomized, double-masked, aflibercept controlled, non-inferiority Phase III trial assessing the efficacy and safety of Duravyu in patients with active wet AMD, including previously treated and treatment-naïve patients. It builds off learnings from the DAVIO and DAVIO 2 clinical trials. In May, Dr. Abbey presented the key results of the DAVIO 2 clinical trial for wet AMD at the 2024 Retina World Congress.
LUGANO aims to enroll approximately 400 patients globally who will be randomly assigned to a 2.7mg dose of Duravyu or an on-label aflibercept control. Patients in the Duravyu treatment arm will receive an intravitreal injection of Duravyu every six months, starting at month two of the trial. It is delivered via a standard intravitreal injection in the physician’s office, similar to current standard practice with FDA approved anti-VEGF treatments. The primary endpoint of the Phase III trial is the average change in best corrected visual acuity (BCVA) at weeks 52 and 56 versus baseline. Secondary endpoints include safety, reduction in treatment burden, percentage of eyes free of supplemental aflibercept injections and anatomical results as measured by optical coherence tomography (OCT). Topline data is anticipated in 2026.
“For more than 50 years now, Texas Retina has been committed to conducting ongoing research in an effort to improve care for our patients and offer them access to promising new treatments for a variety of retina conditions,” shares Dr. Abbey. “We are proud to be the first site to treat a patient in the LUGANO clinical trial and look forward to enrolling more patients.”
Dr. Abbey serves as a Principal Investigator for the LUGANO trial in Texas Retina’s Dallas Main office, and Lori E. Coors, MD, is a Principal Investigator in the Plano office.
For more information about participation in the LUGANO study at Texas Retina, click HERE to contact study coordinators Rachel McCullough (Dallas Main) or Tara Keesling (Plano). Physicians can click HERE to directly refer a patient for this trial.
To learn more about all the clinical trials currently available at Texas Retina, click HERE.