Bausch Health’s Xipere successful in late-stage uveitis study

Bausch Health Companies (NYSE:BHC) unit Bausch + Lomb and licensor Clearside Biomedical (NASDAQ:CLSD) announce positive results from a Phase 3 clinical trial, PEACHTREE, evaluating Xipere (triamcinolone acetonide suprachoroidal injectable suspension) for the treatment of uveitis-associated macular edema. The data were just published in the journal Ophthalmology.

The 160-subject study met the primary endpoint of a statistically significant proportion (47%) of treated patients achieving at least a 15-letter gain in best corrected visual acuity from baseline at week 24 compared to 16% in the control arm (p<0.001).

All key secondary endpoints were also met.

On the safety front, no treatment-related serious adverse events (AEs) were observed. Corticosteroid-related AEs occurred in 11.5% of the treatment group and 15.6% in the control group. The rates of cataract AEs were  7.3% and 6.3%, respectively.

Clearside expects to refile its U.S. marketing application this quarter. It received a CRL in 2019 citing the need for additional stability data.

CLSD is up 9% premarket on light volume.

https://seekingalpha.com/news/3535063-bausch-healths-xipere-successful-in-late-stage-uveitis-study