Clearside Biomedical announced that the FDA has accepted for review the company’s new drug application (NDA) for Xipere (triamcinolone acetonide ophthalmic suspension) for suprachoroidal injection for the treatment of macular edema associated with uveitis. The FDA has determined that the application is sufficiently complete to permit a substantive review.
The PDUFA (Prescription Drug User Fee Act) goal date has been assigned for October 19, 2019. This date reflects a standard review period and is consistent with management’s expectations for the 505(b)(2) filing.
“We are delighted with this positive news on our Xipere NDA. If Xipere is approved, Clearside will have the first therapy indicated for patients suffering from macular edema associated with uveitis,” Daniel H. White, President and Chief Executive Officer, said in a company news 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. 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.”
The NDA filing is supported by data from the phase 3, PEACHTREE clinical trial that demonstrated significant and clinically meaningful improvement in vision for patients with macular edema associated with noninfectious uveitis, and that improvement was achieved across all anatomical locations of uveitis. Also, in patients with active inflammation at baseline, resolution was achieved in more than two-thirds of those treated with Xipere across three commonly used measures of inflammation: vitreous haze, anterior chamber cells and anterior chamber flare.
PEACHTREE, a randomized, masked, sham-controlled phase 3 trial, enrolled 160 patients with macular edema associated with noninfectious uveitis, and compared XIPERE dosed every 12 weeks to sham control. 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 from baseline at week 24, compared to 16% of patients in the sham control arm (P<0.001), using standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity testing. All key secondary and additional endpoints of the PEACHTREE trial were also achieved.