Bausch + Lomb announced that 2 of its pharmaceutical pipeline agents, both first-in-class treatments, will advance to new trials based on recent clinical results.1 The announcement covers a dual-action dry eye disease eye drop advancing to phase 3 and a topical TRPV1 antagonist for ocular surface pain, BL1332, following positive phase 1b results.
Company officials said the results support Bausch + Lomb's approach to developing differentiated therapies with the potential to address significant unmet needs and change the standard of care in eye health.1
Dual-action dry eye drop meets key secondary end point, advances to phase 3
No approved therapy currently addresses both the inflammatory and evaporative drivers of dry eye disease in a single treatment.1 The investigational dual-action eye drop combines 5% lifitegrast, the active ingredient in Xiidra, and perfluorohexyloctane (PFHO), the active ingredient in Miebo, into a single twice-daily treatment.
Frequently Asked Questions
What is the dual-action dry eye drop, and what were the phase 2 results?
The investigational eye drop combines 5% lifitegrast and perfluorohexyloctane into a single twice-daily treatment. It did not meet its primary day 29 endpoint versus lifitegrast alone but showed a significant reduction in tCFS at a prespecified day 15 analysis (P = .0007), the timepoint selected for the phase 3 primary endpoint.
What is BL1332, and what did the phase 1b study show?
BL1332 is a first-in-class topical TRPV1 antagonist for ocular surface pain. In a phase 1b capsaicin-challenge study, it met its primary endpoint, significantly reducing pain intensity versus vehicle, and is now being evaluated in an ongoing phase 2 study in post-photorefractive keratectomy pain.
What should optometrists know about these programs?
Both candidates target mechanisms without a currently approved, mechanism-specific therapy: dual inflammatory/evaporative dry eye treatment in a single drop, and TRPV1-targeted ocular pain relief, with phase 3 and additional phase 2 data expected in the coming months.
A 4-week, randomized, double-masked, parallel-group, active-controlled phase 2 study of the therapy enrolled 443 patients with dry eye disease across 6 arms, including the dual-action drop, lifitegrast alone, PFHO alone, and 3 vehicle masking controls.1 Notably, the study did not meet its primary end point of superiority over lifitegrast alone in reducing total corneal fluorescein staining (tCFS) from baseline at day 29 (P = .196), although a prespecified secondary analysis at day 15—a timepoint the FDA has accepted as a registrational primary endpoint for tCFS—showed a significant reduction in mean tCFS change for the dual-action drop versus lifitegrast alone (P = .0007).1 At day 15, 41.6% of patients receiving the dual-action drop achieved a 3-unit or greater improvement in tCFS, compared with 18.8% receiving lifitegrast alone and 31.6% receiving PFHO alone.1
"This was the first time this combination has been studied in humans, and it did exactly what a phase 2 should do," Yehia Hashad, MD, executive vice president of research and development and chief medical officer at Bausch + Lomb, said in a statement.1 Hashad said the prespecified result achieved at a registrationally accepted time point, with less drug than either individual therapy, gives the company high conviction to advance to phase 3.
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The dual-action drop achieved these results using more than 50% less lifitegrast volume than Xiidra and half the dosing frequency of Miebo, and the safety profile across all 3 treatment groups was consistent with the established profiles of both approved products, with no new safety signals identified.1,2 Bausch + Lomb will advance the combination into phase 3 development with a primary end point at day 15; details of the phase 3 program are expected in the coming months, according to the company.
BL1332 confirms TRPV1 mechanism in first human pain-challenge study
Ocular surface pain is the leading reason patients seek care from eye care professionals, and no therapies are currently approved that specifically target the neurosensory pathways responsible for it. BL1332 is a first-in-class topical TRPV1 antagonist designed to modulate the biological pathways that drive ocular surface pain, rather than addressing associated signs or symptoms alone.1
A phase 1b study evaluated BL1332 0.30% ophthalmic solution in a capsaicin-induced ocular pain challenge model in healthy adults.1 The study met its primary end point, and at 5 seconds following capsaicin challenge, BL1332-treated eyes showed a 5.5-point reduction in mean pain intensity versus vehicle (P < .0001).1 In exploratory analyses, 68.2% of BL1332-treated eyes achieved complete pain resolution compared with 0% of vehicle-treated eyes (P < .0001), and mean pain duration was markedly shorter with BL1332 than vehicle, 1.6 versus 37.8 seconds (P < .0001).1 No new safety signals were identified.
Bausch + Lomb is currently evaluating BL1332 in an ongoing phase 2 study in patients with pain following photorefractive keratectomy surgery, with topline results expected in the coming months. "These results provide the first clinical evidence that targeting TRPV1 can meaningfully reduce ocular pain in humans [who] have not just undergone surgery," Hashad said in a statement, adding that they strengthen confidence in the mechanism as the company continues evaluating BL1332 in patients with clinically relevant pain conditions.1
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