EyePoint Pharmaceuticals announced the presentation of 24-month efficacy and safety data supporting the company’s Yutiq (fluocinolone acetonide intravitreal implant) 0.18 mg 3-year micro-insert for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye. The data were presented by Quan Dong Nguyen, MD, MSc, Professor of Ophthalmology, Byers Eye Institute, Stanford University School of Medicine, at the Retina Sub-Specialty Day at the 2018 American Academy of Ophthalmology (AAO) Annual Meeting in Chicago, at a Late Breaking Developments presentation entitled, “24-month Evaluation of Fluocinolone Acetonide Intravitreal Insert Treatment for Non-Infectious Posterior Uveitis.”
“Decreasing or eliminating uveitis flares is a critical factor in managing noninfectious posterior uveitis as recurrences of attacks can lead to blindness if not properly treated. The 24-month follow-up data from the phase 3 clinical trial of Yutiq showed a significantly increased likelihood of achieving and maintaining inflammation control for Yutiq compared to sham, highlighting the potential of Yutiq to decrease disease recurrences,” Dr. Nguyen said in a company news release. “Patients treated with Yutiq were more likely to not need rescue adjunctive therapies for uveitic inflammation at 24-months compared to sham and no unanticipated side effects were seen. These positive long-term efficacy and safety results of Yutiq are particularly encouraging as treatment options for innovative therapeutics for non-infectious uveitis of the posterior segment are limited, resulting in high unmet medical need for new therapies to treat this devastating, potentially blinding disease.”
Nancy Lurker, EyePoint’s President and Chief Executive Officer, commented, “These promising and durable 24-month clinical results reinforce our belief in the long-lasting potential of a single injection of Yutiq in patients with noninfectious posterior segment uveitis. Yutiq has the potential to address the limitations in the current standard of care by providing a consistent, and highly effective three-year long treatment option to prevent posterior segment uveitic flares with convenient administration done in the physician’s office. We continue to build our commercial infrastructure and sales organization in preparation for the planned U.S. launch of Yutiq in the first quarter of calendar 2019.”
The first double-masked, randomized phase 3 trial of Yutiq enrolled 129 patients in 16 centers in the U.S. and 17 centers outside the U.S., with 87 eyes treated with Yutiq and 42 eyes receiving sham injections. At 24-months of the three-year trial, the recurrence rate in Yutiq randomized eyes was significantly lower than in sham eyes (59.8% vs. 97.6%, respectively; P<0.001). 16.1% of Yutiq treated eyes needed the assistance of adjunctive intraocular/periocular injection medication for uveitic inflammation compared to 66.7% for sham treated eyes. 27.6% of Yutiq treated eyes needed the assistance of adjunctive systemic steroids or immunosuppressants for uveitic inflammation compared to 50.0% for sham treated eyes.
Macular edema was resolved in 84.1% of Yutiq treated eyes and 57.1% of sham treated eyes that had edema recorded at baseline. Intraocular pressure (IOP) lowering drops were used in 41.4% of Yutiq treated eyes and 33.3% of sham treated eyes with IOP lowering surgeries performed in 4.6% of Yutiq treated eyes and 7.1% of sham treated eyes. Cataracts were extracted from 64.3% of patients administered Yutiq with phakic eyes (42) and 14.3% of patients administered sham with phakic eyes (21).
Yutiq was approved by the FDA on October 12, 2018 for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.