Bausch + Lomb Advancing Two First-in-Class Eye Health Therapies Based on Trial Results
Dual-action eye drop targeting both evaporative and inflammatory dry eye disease moving to Phase 3
Positive Phase 1b results for ocular surface pain candidate validate TRPV1 antagonist approach and strengthen confidence in ongoing Phase 2 study
Combined potential peak sales exceeding $2 billion assuming successful development and commercialization1
VAUGHAN, Ontario, August 24, 2026--Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced that two of its pharmaceutical pipeline assets – both first-in-class treatments – will advance to new trials based on recent clinical results.
"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."
Dry Eye Disease Dual-Action Eye Drop: Phase 2 Results Support Advancement to Phase 3 with Day 15 Primary Endpoint
Dry eye disease is a complex, multifactorial condition affecting millions of people worldwide. While existing prescription therapies can effectively address individual causes of dry eye disease, no approved treatment addresses both the inflammatory and evaporative drivers of the disease in a single therapy. Patients often continue to experience persistent symptoms despite treatment, highlighting the need for new approaches that more comprehensively address the condition.
Bausch + Lomb has developed a first-in-class dual-action eye drop that combines 5% lifitegrast (the active ingredient in XIIDRA®) and perfluorohexyloctane (PFHO; the active ingredient in MIEBO®) into a single twice-daily treatment designed to address both ocular surface inflammation and tear evaporation – two of the primary underlying causes of dry eye disease.
Study Design and Results
A four-week, randomized, double-masked, parallel-group, active-controlled Phase 2 study enrolled 443 patients with dry eye disease (age 18 and older) across six arms: the dual-action eye drop, lifitegrast alone, PFHO alone and three 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). A pre-specified secondary analysis at Day 15 – a timepoint accepted by the Food and Drug Administration as a registrational primary endpoint for tCFS – showed a significant reduction in mean change from baseline tCFS for the dual-action eye drop versus 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.