Bausch + Lomb moves dry-eye eye drop to Phase 3 despite missing primary endpoint in Phase 2

Bausch + Lomb reported results of a Phase 2 trial of its dual-action dry-eye eye drop, which combines 5% lifitegrast (the active ingredient in Xiidra) with perfluorohexyloctane (PHFO, sold as Miebo).

The study enrolled over 440 patients and compared the combination drop given twice daily with Xiidra alone, PHFO alone and three vehicle controls. At the primary endpoint (day 29), the combination did not show a statistically significant improvement in total corneal fluorescein staining versus Xiidra.

A prespecified secondary analysis, however, showed a significant benefit at day 15, which the company highlighted as a rapid, robust treatment effect. Based on this finding, Bausch + Lomb said it will advance the candidate into Phase 3 development.

The mixed results illustrate both a setback in meeting the primary efficacy goal and a potential early-timepoint advantage that the firm hopes to confirm in the upcoming late-stage trial.