Chronic Noninfectious Uveitis Safely Treated With Newly Approved Drug
The efficacy and safety of EyePoint Pharmaceuticals 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 was supported by 24-month follow-up data presented at the Annual Meeting of the American Academy of Ophthalmology.
“Decreasing or eliminating uveitis flares is a critical factor in managing non-infectious posterior-uveitis as recurrences of attacks can lead to blindness if not properly treated,” said Quan Dong Nguyen, MD, MSc, professor of ophthalmology, Byers Eye Institute, Stanford University School of Medicine. “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.”
According to Dr Nguyen, who presented the data, the first double-masked, randomized, phase 3 trial of Yutiq enrolled 129 patients in 16 centers in the United States and 17 centers outside the United States, with 87 eyes treated with Yutiq and 42 eyes receiving sham injections. The research team found that at 24-months of the 3-year trial, the recurrence rate in Yutiq randomized eyes was significantly lower than in sham eyes (59.8% vs. 97.6%, respectively; P < .001). The researchers also found that 16.1% of patients treated with Yutiq needed the assistance of adjunctive intraocular/periocular injection medication for uveitic inflammation compared to 66.7% for sham-treated eyes, and 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.
“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,” Dr Nguyen said. “These positive long-term efficacy and safety results of Yutiq are particularly encouraging as treatment options for innovative therapeutics for noninfectious uveitis of the posterior segment are limited, resulting in high unmet medical need for new therapies to treat this devastating, potentially blinding disease.”
The FDA approved Yutiq on October 12, 2018 for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye.
“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,” said Nancy Lurker, EyePoint’s president and chief executive officer.