Bausch + Lomb is moving two first-in-class pharmaceutical pipeline treatments into new clinical trials after recent results showed promising efficacy, including a dry-eye therapy that demonstrated a significant treatment effect at an earlier timepoint.
The global eye-health company said the results support advancing both programs as it seeks to develop therapies for major unmet needs in eye care.
“Helping people see better to live better starts with tackling the challenges patients still face every day,” said Bausch + Lomb CEO Brent Saunders. “These results support our approach to developing differentiated therapies that have the potential to address significant unmet needs and change the standard of care in eye health.”
The most significant development involves a first-in-class eye drop designed to tackle two major drivers of dry eye disease at once: inflammation and tear evaporation.
The twice-daily treatment combines 5% lifitegrast, the active ingredient in XIIDRA, with perfluorohexyloctane (PFHO), the active ingredient in MIEBO.
Bausch + Lomb says the combination could address both ocular-surface inflammation and tear evaporation in a single therapy—an approach not currently offered by an approved treatment.
The four-week Phase 2 trial enrolled 443 patients aged 18 and older and compared the combination with lifitegrast alone, PFHO alone and three vehicle controls.
The study did not meet its primary endpoint: superiority over lifitegrast alone in reducing total corneal fluorescein staining (tCFS) at Day 29. The results nevertheless numerically favored the combination, with a p-value of 0.196.
But an earlier, pre-specified analysis delivered a stronger result.
At Day 15, the combination produced a statistically significant reduction in mean change from baseline tCFS compared with lifitegrast alone, with a p-value of 0.0007.
Moreover, 41.6% of patients receiving the dual-action eye drop achieved at least a three-unit improvement in tCFS, compared with 18.8% for lifitegrast alone and 31.6% for PFHO alone.
The safety profile across all three treatment groups was consistent with the established profiles of XIIDRA and MIEBO, with no new safety signals identified.
The findings have prompted Bausch + Lomb to move the dual-action treatment into Phase 3, using Day 15 as the primary endpoint.
The company noted that the treatment achieved its results with more than 50% less lifitegrast volume than XIIDRA and half the dosing frequency of MIEBO.
Bausch + Lomb said the combination of an early treatment effect, lower drug load and simplified dosing supports Phase 3 studies designed to demonstrate superiority over both individual therapies. Further details are expected in the coming months.
“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,” said Yehia Hashad, executive vice president, R&D and chief medical officer, Bausch + Lomb.
“With a pre-specified result of this strength at a registrationally accepted timepoint achieved with less drug than the individual therapies, and the ability to increase the dose based on an acceptable safety profile, we’re advancing to Phase 3 with a clear design and high conviction.”
