Bausch + Lomb (BLCO) Study result summary

Dual-action dry eye therapy: study design and key findings

• The dual-action eye drop combines lifitegrast and PFHO to address both inflammatory and evaporative causes of dry eye in a single treatment, aiming for superior efficacy and simplified dosing.

• In a four-week, randomized, double-masked, active-controlled Phase 2 study with 443 patients, the dual-action drop used one-third the lifitegrast dose and half the PFHO dosing frequency compared to monotherapies.

• The primary endpoint at day 29 (corneal fluorescein staining vs. lifitegrast) was not statistically significant, but a pre-specified day 15 analysis showed a significant effect (p=0.0007), indicating rapid onset.

• At day 15, 41.6% of dual-action patients achieved a clinically meaningful three-unit improvement in corneal staining, outperforming both monotherapies.

• Symptom resolution at day 15 favored the dual-action drop over lifitegrast and was comparable or better than Miebo, with tolerability comparable or better than monotherapies.

Dosing, safety, and future development

• The dual-action drop achieved efficacy with lower drug exposure and less frequent dosing, supporting a differentiated profile and potential for improved patient adherence.

• Safety profile was consistent with established drugs, with lower rates of instillation site irritation and dysgeusia compared to lifitegrast alone, and no new safety signals observed.

• The rapid effect at day 15 will guide future Phase 3 study design, with plans to optimize dose and frequency using modeling and simulation.

• Regulatory discussions are ongoing, with confidence that a 15-day endpoint is approvable given the unprecedented early effect on corneal staining.

• Superiority over MIEBO and individual therapies will be required for approval, and data suggest potential to achieve this with dose optimization.

BL1332 ocular surface pain program: study design and results

• BL1332, a potent topical TRPV1 antagonist, was evaluated in a two-part Phase 1b study using a capsaicin-induced pain model in healthy volunteers.

• The primary endpoint showed a dramatic reduction in pain intensity (mean score 0.6 vs. 6.1 for vehicle) five seconds after challenge, with 68.2% of BL1332-treated participants reporting complete pain resolution.

• No participants on BL1332 reported severe pain, and pain duration was reduced to 1.6 seconds vs. 37.8 seconds for vehicle.

• No treatment-emergent adverse events or systemic safety concerns were observed; topical dosing resulted in ultra-low systemic exposure.

• The study validates TRPV1 antagonism as a mechanism for ocular pain relief and supports broader development, with ongoing Phase 2 study in post-surgical pain.