Bausch + Lomb will advance a dual-action dry eye disease eye drop into Phase 3 testing after a Phase 2 study missed its primary endpoint at Day 29 but showed a statistically significant benefit at a pre-specified Day 15 secondary endpoint.
The company is also continuing development of BL1332, a topical treatment for ocular surface pain, after a Phase 1b study met its primary endpoint in a capsaicin-induced pain challenge in healthy adults. Bausch + Lomb said the two first-in-class programs could have combined potential peak sales exceeding $2 billion, assuming successful development and commercialization.
The dry eye candidate combines 5% lifitegrast, the active ingredient in XIIDRA, with perfluorohexyloctane, or PFHO, the active ingredient in MIEBO. The twice-daily eye drop is designed to address both ocular surface inflammation and tear evaporation, two underlying contributors to dry eye disease.
The four-week, randomized, double-masked, active-controlled Phase 2 study enrolled 443 adults across six treatment arms. The trial did not demonstrate superiority to lifitegrast alone in reducing total corneal fluorescein staining from baseline at Day 29, the primary endpoint, although results numerically favored the combination treatment, with a p-value of 0.196.
At Day 15, a pre-specified secondary analysis, the combination significantly reduced mean total corneal fluorescein staining compared with lifitegrast alone, with a p-value of 0.0007. A total of 41.6% of patients on the dual-action treatment achieved at least a three-unit improvement, compared with 18.8% on lifitegrast and 31.6% on PFHO alone.
Bausch + Lomb plans to use Day 15 as the primary endpoint in Phase 3. The company said the eye drop used more than 50% less lifitegrast volume than XIIDRA and was dosed half as frequently as MIEBO. No new safety signals were observed.
Separately, BL1332, a 0.30% topical TRPV1 antagonist, reduced pain intensity by 5.5 points versus vehicle five seconds after a capsaicin challenge in Phase 1b testing, with a p-value below 0.0001. Mean pain duration was 1.6 seconds with BL1332 versus 37.8 seconds with vehicle.
BL1332 is being studied in an ongoing Phase 2 trial for pain after photorefractive keratectomy surgery, with topline results expected in coming months.
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