Bausch + Lomb advances Xiidra–Miebo combination to Phase 3 despite mixed Phase 2 results

Bausch + Lomb’s investigational dual-action dry-eye drop combines lifitegrast, the active ingredient in Xiidra, with perfluorohexyloctane (PFHO), the active ingredient in Miebo.

The Phase 2 trial enrolled 443 adults and compared the combination with Xiidra, Miebo/PFHO, and vehicle controls.

The combination missed its primary endpoint at Day 29:
improvement in total corneal fluorescein staining was numerically better than Xiidra alone but not statistically significant (P=.196).

A prespecified Day 15 analysis did show statistically significant superiority versus Xiidra (P=.0007). At least a three-unit improvement in corneal staining occurred in 41.6% of combination patients, versus 18.8% with Xiidra and 31.6% with PFHO alone.

No new safety signals were reported; adverse effects were broadly consistent with the established profiles of Xiidra and Miebo.

Despite the failed Day 29 primary endpoint, Bausch + Lomb plans to advance the combination into Phase 3, using Day 15 as the primary efficacy time point. Further trial details are expected in the coming months.

The rationale is a two-pronged treatment:
lifitegrast targets ocular-surface inflammation while PFHO reduces tear evaporation. The combination is administered twice daily, potentially simplifying treatment compared with Miebo alone, which is dosed four times daily.