While Bausch + Lomb’s dual-action eye drops failed to outperform active comparators at day 29, the investigational asset showed significant superiority at day 15.
Bausch + Lomb’s investigational eye drop missed its primary efficacy goal in a mid-stage study of dry eye disease, but the Canadian company is nevertheless taking the asset into Phase 3 development based on what CMO Yehia Hashad claimed is a “rapid, robust treatment effect.”
Bausch + Lomb’s eye drop candidate is a dual-action therapy that combines two of its dry eye disease therapies: 5% lifitegrast, the active ingredient in Xiidra, and perfluorohexyloctane (PHFO), which the pharma sells as Miebo. The Phase 2 study compared the experimental drop, given twice daily, against Xiidra alone, PHFO alone and three vehicle controls. More than 440 patients with dry eye disease participated.
Results, revealed in a Monday press release, showed that the investigational eye drop failed to significantly improve eye damage, as measured by total corneal fluorescein staining (tCFS), at day 29 versus Xiidra alone—though Bausch + Lomb detected an effect that “numerically favored” the investigational combination.
Moreover, a prespecified secondary analysis pointed to a significant treatment benefit at 15 days in those treated with the candidate versus Xiidra alone. Day 15 is “a timepoint accepted by the Food and Drug Administration as a registrational primary endpoint for tCFS,” the company noted.
“This was the first time this combination has been studied in humans, and it did exactly what a Phase 2 should do: demonstrated a rapid, robust treatment effect and told us precisely when to measure it,” CMO Hashad, also executive vice president of R&D at Bausch + Lomb, said in a statement.
Based on the outcomes of this secondary assessment, Bausch + Lomb has decided to push forward with Phase 3 development for the candidate, this time employing a primary endpoint analysis at day 15. The late-stage study will again compare the dual-action eye drop against its individual components. More details regarding the design, as well as the study’s timeline, will be disclosed “in the coming months,” the company said.
In November last year, Bausch + Lomb announced that Phase 3 data for the dual-action drops could come in 2028, with a potential launch date estimated for 2029 if approved. The company at the time also forecast peak sales of around $700 million for the drug—an estimate that the company reaffirmed on Monday.
