EyePoint Pharmaceuticals announced positive topline 36-month follow-up data from the second Phase 3 trial of YUTIQ® (fluocinolone acetonide intravitreal implant) 0.18 mg three-year micro-insert for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.
"The durable 36-month follow-up data from the second Phase 3 trial of YUTIQ highlight its long-term ability to reduce uveitic flares, consistent with the findings from the first Phase 3 trial. Reduction of uveitic flares is a key component in the treatment of this devastating disease leading to progressive vision loss and blindness, thus the recurrence rate of 46.5% at 36-months is compelling," said Dr. Thomas Albini, Professor of Clinical Ophthalmology at Bascom Palmer Eye Institute in Miami, Florida. "Safety data showed no unanticipated side effects at each follow-up timepoint at 12-, 24-, and 36-months. These promising efficacy and safety data, coupled with a one-time administration, further position YUTIQ as a new, innovative treatment alternative for patients suffering from chronic non-infectious uveitis affecting the posterior segment of the eye."
"We continue to believe YUTIQ is a differentiated treatment option compared to existing therapies because of its highly efficacious and solid safety profile, coupled with its convenient, single administration and long-term consistent dosing of drug," said Nancy Lurker, President and Chief Executive Officer of EyePoint Pharmaceuticals. "The 36-month results provide additional support in its long-acting potential, a characteristic consistently regarded by treating physicians as a critical treatment advantage. Our commercial efforts are yielding increased reception and adoption from uveitis specialists across the U.S., as well as positive patient feedback on the YUTIQ product profile."
The second double-masked, randomized Phase 3 trial of YUTIQ enrolled 153 patients in 15 clinical centers in India, with 101 eyes treated with YUTIQ and 52 eyes receiving sham injections. At 36-months, the recurrence rate in YUTIQ randomized eyes was significantly lower than in sham treated eyes (46.5% vs. 75.0%, respectively; p=0.001). Visual acuity gains or losses of 3-lines or more were both similar between treatment groups. Considerably fewer YUTIQ-treated eyes (8.9%) needed the assistance of adjunctive intraocular/periocular injection medication for uveitic inflammation compared to sham treated eyes (51.9%); 31.7% of YUTIQ treated eyes needed the assistance of an adjunctive systemic steroid or immunosuppressant compared to 32.7% for sham treated eyes.
Macular edema was resolved in 75.8% of YUTIQ treated eyes and 53.8% of sham treated eyes that had edema recorded at baseline. Mean intraocular pressure (IOP) at 36 months was 14.8 mmHg and 13.4 mmHg in the YUTIQ treated eyes and sham treated eyes, respectively. Intraocular pressure lowering drops were used in 74.3% of YUTIQ treated eyes and 73.1% of sham treated eyes. IOP lowering surgeries were performed in 2.0 % of YUTIQ treated eyes and in none in the sham treated eyes. In patients with phakic eyes when enrolled in the study cataracts were extracted from 70.5% of patients administered YUTIQ and 26.5% of patients administered sham by the final 36-month time point of the study.
YUTIQ® (fluocinolone acetonide intravitreal implant) 0.18 mg is indicated for the treatment of chronic, non-infectious uveitis affecting the posterior segment of the eye, and was approved by the FDA on October 12, 2018.
Non-infectious posterior segment uveitis is a chronic, non-infectious inflammatory disease affecting the posterior segment of the eye, often involving the retina, which affects people of all ages, producing swelling and destroying eye tissues, which can lead to severe vision loss and blindness. In the U.S., posterior segment uveitis is estimated to affect between 55,000 - 120,000 people resulting in approximately 30,000 cases of blindness, making it the third leading cause of blindness in the U.S. Today, patients with posterior uveitis are typically treated with either local steroid injections, with limited duration of effect, or systemic steroids, but over time frequently develop serious side effects that can limit effective dosing. Patients then often progress to steroid-sparing therapy with systemic immune suppressants or biologics, which themselves can have severe side effects including an ...
(All Rights Reserved)