Bausch + Lomb has announced plans to advance its investigational dual-action dry eye disease (DED) eyedrop into Phase 3 development. The announcement follows results from a Phase 2 clinical trial.
A first-in-class investigational treatment, the twice-daily eyedrop combines 5% lifitegrast, the active ingredient in Xiidra, with perfluorohexyloctane (PFHO), the active ingredient in Miebo. The combination is designed to address ocular surface inflammation and tear evaporation, two underlying causes of DED.
Phase 2 Results
The Phase 2 trial marked the first clinical study of the combination. Without previous human data to establish the timing of the combined treatment effect, researchers selected Day 29 for the study’s primary endpoint.
The trial did not meet that endpoint, which evaluated superiority over lifitegrast alone in reducing total corneal fluorescein staining from baseline at Day 29. Results did not reach statistical significance (p=0.196) but numerically favored the dual-action treatment, the company says.
In addition, the company notes that the dual-action drop achieved the study results using more than 50% less lifitegrast volume than Xiidra and with half the dosing frequency of Miebo. Across all three treatment groups, the safety findings remained consistent with the established profiles of Xiidra and Miebo, with investigators identifying no new safety signals.
Based on the overall findings, Bausch + Lomb plans to move the treatment into Phase 3 with a primary endpoint at Day 15.
Ocular Surface Pain Program Advances
Bausch + Lomb also reported positive Phase 1b results for BL1332, its investigational topical TRPV1 antagonist designed to target a receptor involved in ocular pain signaling.
The company is now evaluating BL1332 in a Phase 2 study of patients experiencing pain following photorefractive keratectomy surgery. Bausch + Lomb says it expects topline results within the next few months and is evaluating the therapy’s potential across post-surgical, acute, and chronic ocular surface pain.