Bausch + Lomb Advances Dry Eye Drug to Phase III as Pain Candidate Hits Phase Ib Goal

Bausch + Lomb plans to advance its dual-action dry eye treatment to Phase III after it significantly improved corneal staining at day 15, despite missing the primary endpoint at day 29. The company expects to use the day 15 measure in the next trial and will consult with the FDA.

The treatment combines MIEBO’s tear-evaporation reduction with XIIDRA’s anti-inflammatory activity; 41.6% of patients achieved a three-unit corneal-staining improvement at day 15, versus 18.8% for lifitegrast alone, with no new safety signals.

BL1332 met its Phase Ib endpoint in an ocular pain study, reducing mean pain intensity to 0.6 versus 6.1 for placebo and shortening pain duration to 1.6 seconds versus 37.8 seconds. Phase II results in post-surgical ocular pain are expected later this year.

Bausch + Lomb NYSE: BLCO said it plans to advance a dual-action dry eye treatment into Phase III development after a Phase II study showed statistically significant improvement in corneal staining at day 15, although the trial did not meet its primary endpoint at day 29.

The company also reported Phase Ib results for BL1332, an ocular surface pain candidate designed to block the TRPV1 receptor. The study met its primary endpoint in a capsaicin-induced pain model in healthy volunteers, according to the company.

Chief Executive Officer Brent Saunders said the two programs represent “more than $2 billion in combined potential peak sales” and could provide growth opportunities beyond 2028. He said neither program is expected to launch within the company’s previously outlined three-year plan, though the associated clinical-development spending had been anticipated.

Bausch + Lomb’s dual-action eye drop combines the active ingredients in MIEBO and XIIDRA. MIEBO’s active ingredient, perfluorohexyloctane, or PFHO, is intended to reduce tear evaporation, while XIIDRA’s active ingredient, lifitegrast, acts as an anti-inflammatory.

Mayssa Attar, head of pharmaceutical R&D, said the four-week randomized, double-masked, active-controlled study enrolled 443 patients across six treatment and vehicle-control arms. The prespecified primary endpoint was change from baseline in total corneal fluorescein staining at day 29 compared with lifitegrast alone. The combination treatment was numerically better than lifitegrast at day 29 but did not achieve statistical significance.

However, at the prespecified day 15 assessment, the dual-action drop significantly reduced corneal staining versus lifitegrast alone, with a p-value of 0.0007. At day 15, 41.6% of patients receiving the dual-action drop achieved a three-unit improvement in corneal staining, compared with 18.8% for lifitegrast alone and 31.6% for PFHO alone. The company said the combination treatment was administered twice daily, compared with four daily doses for PFHO alone, and used a 12-microliter drop volume versus 35 microliters in the lifitegrast-alone arm.

Attar said the combination numerically outperformed lifitegrast across several symptom-resolution measures, including itching, light sensitivity, blurred vision, irritation, burning and foreign-body sensation. Results versus PFHO were mixed, with the combination performing better on some measures and comparably or slightly below PFHO on others. No new safety signals were observed, the company said. Instillation-site irritation occurred in 11.9% of patients receiving the combination therapy, compared with 21.2% for lifitegrast alone, while dysgeusia occurred in 10.9% and 15.