FDA approves Bausch + Lomb and Clearside’s XIPERE for macular edema

The FDA approved XIPERE (triamcinolone acetonide injectable suspension) for suprachoroidal use. It will be used to treat macular edema associated with uveitis.

The approval makes XIPERE the first — and currently only — therapy utilizing suprachoroidal to treat macular edema associated with uveitis, according to Joseph C. Papa, chairman and CEO of Bausch Health, in a company news release.

XIPERE is designed to provide treatment via the suprachoroidal administration with the proprietary SCS Microinjector developed by Clearside Biomedical, the news release stated.

The microinjector works by targeting and compartmentalizing delivery and higher proportions of absorption that is relative to intravitreal injection.

Three clinical programs investigated XIPERE: PEACHTREE, a randomized, multi-center, double-masked, sham-controlled phase clinical trial; MAGNOLIA, a multi-center, non-interventional extension study; and AZALEA, an open-label safety trial.

FDA approval was based on results from the PEACHTREE trial, which included 160 patients diagnosed with macular edema associated with uveitis. XIPERE is also the first — and only — treatment for uveitic macular edema to demonstrate clinical efficacy with a best-corrected visual acuity (BCVA) primary endpoint, according to the release.

The primary efficacy endpoint consisted of the proportion of patients in whom BCVA had improved by at least 15 letters from baseline after 24 weeks of follow-up, the release stated.

Additionally, the PEACHTREE trial found a statistically significant greater proportion of patients treated with XIPERE (47%) achieved at least a 15-letter improvement in BCVA than patients in the control arm (16%, p< 0.01) at Week 24, according to the release.

XIPERE is expected to be available during the first quarter of 2022.