Clearside Biomedical announced that the Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Xipere (triamcinolone acetonide ophthalmic suspension) for Suprachoroidal Injection for the treatment of macular edema associated with uveitis.
Xipere is a proprietary suspension of triamcinolone acetonide, a corticosteroid. It is intended for suprachoroidal injection for drug delivery between the choroid and the sclera. This route of administration allows for rapid and adequate drug dispersion to the back of the eye while reducing the risk of harm to the healthy parts of the eye.
The NDA included results from the phase 3 randomized, masked, sham-controlled PEACHTREE trial (N=160) which compared Xipere administered every 12 weeks vs sham control.
Results showed that treatment with Xipere led to a significant and clinically meaningful improvement in vision among patients with macular edema associated with non-infectious uveitis; this benefit was achieved across all anatomical locations of uveitis. The primary endpoint of the study was met, with a greater proportion of patients in the Xipere group gaining at least 15 letters in best corrected visual acuity from baseline at week 24 (47% vs 16% in the sham control group; P <.001).
In addition, resolution of inflammation (based on vitreous haze, anterior chamber cells and anterior chamber flare) was seen in over two-thirds of patients who received Xipere.
The FDA has set a target Prescription Drug User Fee Act (PDUFA) date of October 19, 2019 for the application.
For more information visit ClearsideBio.com.