Phase III trial of Yutiq shows positive topline results in uveitis.- EyePoint Pharma
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Published:3rd Mar 2020
EyePoint Pharmaceuticals announced positive topline 36-month follow-up data from the second Phase III 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 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.