Clearside Biomedical announced that it has submitted a new drug application (NDA) to the FDA for Xipere for the treatment of macular edema associated with uveitis.
If approved by the FDA, Xipere would be the first therapy for macular edema associated with uveitis.
“Based on the data from PEACHTREE, our pivotal phase 3 clinical trial, we believe that Xipere has the potential to become a new paradigm in the treatment of uveitic macular edema,” Daniel White, Chief Executive Officer and President of Clearside, said in a company news release. “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.”
Mr. White added that the company has a commercial team preparing for the potential launch of Xipere and plans to submit applications for regulatory approval in select markets outside of the United States.