The FDA has accepted a new drug application for Xipere suprachoroidal injection for the treatment of macular edema associated with uveitis, according to a Clearside Biomedical press release.
“Macular edema is the leading cause of vision loss, and even blindness, in uveitis patients, and we are now one step closer to treating this underserved patient population,” Clearside President and CEO Daniel H. White said in the release. “Over the last several months, our team has worked diligently to reach this milestone, and we are now preparing to launch the product if approved.”
In the phase 3 PEACHTREE clinical trial, Xipere (triamcinolone acetonide ophthalmic suspension) was shown to improve vision in patients who had macular edema with noninfectious uveitis.
A PDUFA date has been set for Oct. 19.