Bausch + Lomb to pursue Phase 3 dry-eye trial despite Phase 2 endpoint miss

Bausch + Lomb plans to advance a dual-action dry-eye treatment into Phase 3, even though it missed the Phase 2 study’s primary endpoint at Day 29.

The combination drop pairs lifitegrast, the active ingredient in Xiidra, with perfluorohexyloctane, the active ingredient in Miebo.

In the 443-patient Phase 2 trial, the treatment did not significantly outperform Xiidra alone in reducing corneal staining at Day 29; results numerically favored the combination, but the difference was not statistically significant.

A prespecified analysis at Day 15 showed a statistically significant benefit versus Xiidra alone. At that point, 41.6% of combination-treatment patients achieved at least a three-unit improvement in corneal staining, compared with 18.8% for Xiidra alone and 31.6% for Miebo alone.

Bausch + Lomb says Day 15 is a timepoint accepted by the FDA as a registrational primary endpoint for corneal-staining measurements and intends to use it as the main endpoint in the Phase 3 program.

The company reported no new safety signals, with adverse-event profiles consistent with the established products. Further Phase 3 details are expected in the coming months.