Bausch + Lomb has developed a first-in-class combination eye drop targeting two of the primary underlying causes of dry eye disease simultaneously.
The novel treatment combines 5% lifitegrast, the active ingredient in Xiidra, with perfluorohexyloctane, known as PFHO and the active ingredient in Miebo, into a single twice-daily drop.
The formulation is designed to address both ocular surface inflammation and tear evaporation, which are two of the most significant drivers of dry eye disease in patients.
A Phase 2 study enrolled 443 patients with dry eye disease across six treatment arms, using a randomized, double-masked, parallel-group, active-controlled design over four weeks.
The trial compared the dual-action drop against lifitegrast alone, PFHO alone, and three separate vehicle masking control groups to assess its relative performance.
Day 29 was selected as the primary endpoint timepoint, given the absence of prior human clinical data on the timing of any combined treatment effect from the two agents together.
The study did not meet its primary endpoint of superiority over lifitegrast alone in reducing total corneal fluorescein staining from baseline at Day 29.
Despite missing the primary endpoint, the combination demonstrated a numerical trend toward benefit at Day 29, keeping interest in the programme alive among researchers and investors.
A pre-specified secondary analysis at Day 15 showed a statistically significant mean change in corneal staining among patients treated with the lifitegrast-perfluorohexyloctane combination, providing a key basis for moving forward.
Bausch + Lomb has stated that the FDA accepts 15 days as a valid timepoint for a registrational study in dry eye disease, lending regulatory credibility to the revised development path.
The company confirmed it will advance the combination into Phase 3 development with the primary endpoint now set at Day 15, rather than the Day 29 measure used in Phase 2.
Full details of the Phase 3 programme are expected to be disclosed in the coming months, with the company signalling confidence in the treatment’s eventual regulatory and commercial prospects.
Notably, the dual-action drop achieved its results using more than 50% less lifitegrast volume than Xiidra and half the dosing frequency of Miebo, suggesting a more patient-friendly profile.
The safety data across all three active treatment groups remained consistent with the established profiles of both approved products, with no new safety signals identified during the trial.