Bausch Health + Clearside Biomedical announce publication of pivotal phase III data on Xipere in Ophthalmology journal.

Bausch Health Companies Inc and Bausch + Lomb, its leading global eye health business, and Clearside Biomedical, Inc. announced that "Ophthalmology ", the peer-reviewed journal of the American Academy of Ophthalmology, has published results from the randomized, controlled, double-masked Phase III clinical trial (PEACHTREE study) of Xipere (triamcinolone acetonide suprachoroidal injectable suspension), an investigational therapy with a proposed indication of treatment of macular edema associated with uveitis. The data demonstrated that patients with noninfectious uveitis in the Xipere study arm experienced clinically significant improvement in vision relative to the control arm, demonstrating the potential efficacy of suprachoroidal injection of Xipere for the treatment of macular edema associated with uveitis. No serious adverse events (AEs) considered by the investigators related to treatment were reported. About the Phase III PEACHTREE Study : The PEACHTREE study was a randomized, controlled, masked, Phase III clinical trial that evaluated the safety and efficacy of Xipere in 160 patients with macular edema associated with noninfectious uveitis. Patients were randomized to receive Xipere at baseline and at 12 weeks versus control. The PEACHTREE study met its primary endpoint, with 47 percent of patients in the Xipere arm gaining at least 15 letters in best corrected visual acuity from baseline at week 24, compared to 16 percent of patients in the control arm (p<0.001), using the standardized early treatment of diabetic retinopathy study scale (visual acuity testing). all key secondary and additional endpoints of the peachtree study were also achieved. no serious aes considered by the investigators to be related to treatment were reported. corticosteroid-associated aes of elevated intraocular pressure occurred in 11.5% and 15.6% of the xipere and control groups, respectively. cataract ae rates were comparable (7.3% and 6.3%, respectively). see-. steven y, et al. "efficacy and safety of suprachoroidal cls-ta for macular edema secondary to noninfectious uveitis:phase iii, randomized trial". ophthalmology. 2020: doi:10.1016 j.ophtha.2020.01.006.>