Bausch + Lomb Advances Dual-Action Dry Eye Drop to Phase 3, Reports Positive Pain Drug Data

Bausch + Lomb has confirmed its investigational dual-action dry eye drop, combining lifitegrast (Xiidra) and perfluorohexyloctane (Miebo) in one twice-daily formulation, will advance to Phase 3, alongside positive early results for its ocular pain candidate BL1332.

In a 443-patient Phase 2 trial, the combination drop missed its primary endpoint of superiority over lifitegrast alone on corneal staining at Day 29 (p=0.196). However, a pre-specified Day 15 analysis, an FDA-accepted registrational timepoint, showed a significant benefit over lifitegrast alone (p=0.0007), with 41.6% of patients achieving a clinically meaningful improvement versus 18.8% on lifitegrast and 31.6% on PFHO alone. The effect was seen with over 50% less lifitegrast than Xiidra and half Miebo's dosing frequency. Phase 3 will use Day 15 as the primary endpoint.

Separately, a Phase 1b study of BL1332, a topical TRPV1 antagonist for ocular surface pain, met its primary endpoint in a capsaicin pain-challenge model, cutting pain intensity significantly versus vehicle (p<0.0001) with no new safety signals. A Phase 2 study in post-PRK surgical pain is under way, with results due in coming months.

"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," said Bausch + Lomb CEO Brent Saunders.

Bausch + Lomb estimates combined peak sales potential of more than US$2 billion (approximately 2.8 billion AU$) across both programs (~$700M US$ for the dry eye drop, ~$1.4B US$ for BL1332), with commercial contribution expected beyond 2028. Neither product is yet approved in any market.