Clearside Biomedical’s Phase 3 PEACHTREE trial data paper named one of the best from AAO 2018’s Original Papers sessions
A paper reporting data from Clearside Biomedical’s (NASDAQ:CLSD) Phase 3 PEACHTREE trial of XIPERE (formerly, suprachoroidal CLS-TA) in patients with uveitic macular edema was named a best original paper at the recent meeting of the American Academy of Ophthalmology.
During the Original Papers sessions at the 2018 AAO annual meeting, the expert panels moderating those presentations each named the paper that they rated most highly. The PEACHTREE data paper was part of the “Uveitis, Intraocular Inflammation” session.
The paper, presented by Dr. Rahul Khurana, was titled, “Phase 3 Efficacy Data of Suprachoroidally Injected CLS-TA for Macular Edema Due to Non-infectious Uveitis.”
PEACHTREE, a randomized, masked, sham-controlled Phase 3 trial, enrolled 160 patients with macular edema associated with non-infectious uveitis, comparing XIPERE dosed every 12 weeks to sham control.
The PEACHTREE trial met its primary endpoint at 24 weeks, with 47% of patients in the XIPERE arm gaining at least 15 ETDRS letters in best corrected visual acuity from baseline, compared to 16% of patients in the sham control arm (p<0.001). All key secondary and additional endpoints of the PEACHTREE trial were also achieved.
Dr. Kurana’s presentation also reported for the first time that patients with uveitis from each of the four anatomic subtypes (anterior, intermediate, posterior and panuveitis) treated with XIPERE achieved significant visual improvement.
Clearside expects to submit an NDA for XIPERE to treat macular edema associated with non-infectious uveitis to the FDA by the end of 2018.