Bausch + Lomb announced in a press release that its first-in-class dual-action eye drop, designed to address both ocular surface inflammation and tear evaporation, will advance to a phase 3 trial. The eye drop combines 5% lifitegrast (the active ingredient in Xiidra) and perfluorohexyloctane (PFHO; the active ingredient in Miebo) into a single twice-daily treatment.

According to the company, a 4-week, randomized, double-masked, parallel-group, active-controlled phase 2 study enrolled 443 patients with dry eye disease (age 18 and older) across 6 arms: the dual-action eye drop, lifitegrast alone, PFHO alone, and 3 vehicle masking controls. This was the first clinical study of the combination, and day 29 was selected as the primary endpoint timepoint in the absence of prior human data on the timing of the combined treatment effect.

The study did not meet its primary endpoint of superiority over lifitegrast alone in reducing total corneal fluorescein staining (tCFS) from baseline at day 29, although results numerically favored the dual-action eye drop (P=0.196), the company said. A pre-specified secondary analysis at day 15—a timepoint accepted by the US Food and Drug Administration (FDA) as a registrational primary endpoint for tCFS—showed a significant reduction in mean change from baseline tCFS for the dual-action eye drop vs lifitegrast alone (P=0.0007). At day 15, 41.6% of patients treated with the dual-action eye drop achieved a ≥3-unit improvement in tCFS, compared with 18.8% of patients treated with lifitegrast alone and 31.6% treated with PFHO alone.

The safety profile in all 3 treatment groups was consistent with the established profiles of Xiidra and Miebo, with no new safety signals identified. Bausch + Lomb said the data provides a clear path forward, and the company will advance the dual-action eye drop into phase 3 development with a primary endpoint at day 15.

According to Bausch + Lomb, the dual-action eye drop achieved these results with more than 50% less lifitegrast volume than Xiidra and half the dosing frequency of Miebo. The company said that this profile—a rapid treatment effect at a lower drug load and simplified dosing regimen—supports the design of phase 3 studies to demonstrate superiority to both individual therapies. Bausch + Lomb said details about the phase 3 program will be shared in the coming months. OM