Xipere filed in NDA to FDA for uveitis.- Clearside Biomedical.

Clearside Biomedical announced that it has submitted a New Drug Application for Xipere (triamcinolone acetonid) to the FDA for the treatment of macular edema associated with uveitis. The PEACHTREE trial met its primary endpoint, with 47% of patients in the Xipere arm gaining at least 15 letters in best corrected visual acuity, as measured using the Early Treatment of Diabetic Retinopathy Study scale, from baseline at week 24, compared to 16% of patients in the sham control arm (p<.001). all key secondary and additional endpoints of the peachtree trial were also achieved.>

PEACHTREE was the first clinical trial to demonstrate significant improvement in vision for patients with macular edema associated with non-infectious uveitis, and that improvement was achieved across all anatomical locations of uveitis. In addition, signs of inflammation resolved in more than two-thirds of patients treated with Xipere across three commonly used measures of inflammation in the eye: vitreous haze; anterior chamber cells and anterior chamber flare. The company also plans to submit applications for regulatory approval in select markets outside of the US.