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Bausch + Lomb is advancing two key pipeline candidates, one for dry eye disease and another for ocular pain. The dry eye candidate’s Phase II results show promise with earlier efficacy observed at day 15, though the primary endpoint at day 29 was not met. This necessitates further discussions with regulatory bodies like the FDA regarding the chosen endpoint for Phase III. The pain candidate, BL1332, demonstrated strong results in its Phase Ib trial, indicating significant potential for pain relief and a favorable safety profile compared to earlier compounds. The success of these programs will be crucial for Bausch + Lomb’s future growth, especially as they aim to exceed $2 billion in combined peak sales.
Bausch + Lomb (NYSE:BLCO) announced on August 24, 2026, that it is progressing a dual-action dry eye treatment candidate to Phase III development following positive results in a Phase II study. The trial demonstrated a statistically significant improvement in corneal staining at day 15, although the primary endpoint at day 29 was not met.
Concurrently, the company reported that its ocular surface pain candidate, BL1332, designed to block the TRPV1 receptor, met its primary endpoint in a Phase Ib study utilizing a capsaicin-induced pain model in healthy volunteers.
According to Chief Executive Officer Brent Saunders, these two programs collectively represent an estimated potential for over $2 billion in peak sales and could provide growth avenues beyond 2028. While neither is projected to launch within the company’s stated three-year plan, the associated clinical development expenditures were anticipated.
Dry Eye Candidate’s Early Efficacy Noted
The dual-action dry eye treatment combines perfluorohexyloctane (PFHO), intended to reduce tear evaporation, with lifitegrast, an anti-inflammatory agent. The four-week, randomized, double-masked, active-controlled Phase II study enrolled 443 patients.
While the combination treatment showed a numerical advantage over lifitegrast alone at day 29, it did not achieve statistical significance. However, at a prespecified day 15 assessment, the dual-action drop demonstrated a significant reduction in corneal staining compared to lifitegrast alone, with a p-value of 0.0007. At day 15, 41.6% of patients on the combination therapy achieved a three-unit improvement in corneal staining, versus 18.8% for lifitegrast alone and 31.6% for PFHO alone.
The combination therapy was administered twice daily, utilizing a 12-microliter drop volume. The company indicated that the combination numerically outperformed lifitegrast across several symptom measures, including itching, light sensitivity, and irritation, with mixed results compared to PFHO.
No new safety signals were reported. Instillation-site irritation was observed in 11.9% of patients receiving the combination, compared to 21.2% for lifitegrast alone. Bausch + Lomb intends to use the day 15 assessment as the primary endpoint for its Phase III trial and will leverage modeling and simulation for dose determination.
BL1332 Pain Candidate Achieves Phase Ib Target
BL1332, a topical TRPV1 antagonist, aims to modulate pain signaling on the ocular surface. The company reports it is approximately 100 times more potent and more water-soluble than its prior-generation TRPV1 candidate, BL-1312.
The Phase Ib trial involved two parts: identifying a capsaicin concentration for target pain response and a crossover study with 22 participants receiving BL1332 and placebo. The primary endpoint measured pain intensity five seconds post-capsaicin challenge, with mean pain intensity reported as 0.6 for BL1332 versus 6.1 for vehicle, a statistically significant difference.
Sixty-eight percent of participants on BL1332 reported complete pain resolution, compared to none on vehicle. Mean pain duration was 1.6 seconds for BL1332 and 37.8 seconds for vehicle. Severe pain (score of 7 or higher) was not reported by any participant on BL1332.
No treatment-emergent adverse events, serious adverse events, or discontinuations were reported. Previous Phase I studies assessing systemic exposure and thermoregulatory safety showed no hyperthermia. Bausch + Lomb anticipates Phase II results for BL1332 in post-surgical ocular pain later this year and plans to evaluate it in other acute and chronic ocular pain conditions, including dry eye disease-associated pain.
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