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- Dual-action eye drop targeting both evaporative and inflammatory dry eye disease moving to Phase 3<\/i><\/li>\n
- Positive Phase 1b results for ocular surface pain candidate validate TRPV1 antagonist approach and strengthen confidence in ongoing Phase 2 study<\/i><\/li>\n
- Combined potential peak sales exceeding $2 billion assuming successful development and commercialization1<\/sup><\/i><\/li>\n<\/ul>\n
VAUGHAN, Ontario–(BUSINESS WIRE<\/a>)–
\nBausch + Lomb Corporation (NYSE\/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced that two of its pharmaceutical pipeline assets \u2013 both first-in-class treatments \u2013 will advance to new trials based on recent clinical results.<\/p>\n\n\u201cHelping people see better to live better starts with tackling the challenges patients still face every day,\u201d said Bausch + Lomb CEO Brent Saunders. \u201cThese 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.\u201d<\/p>\n
Dry Eye Disease Dual-Action Eye Drop: Phase 2 Results Support Advancement to Phase 3 with Day 15 Primary Endpoint<\/b><\/p>\n
\nDry eye disease is a complex, multifactorial condition affecting millions of people worldwide. While existing prescription therapies can effectively address individual causes of dry eye disease, no approved treatment addresses both the inflammatory and evaporative drivers of the disease in a single therapy. Patients often continue to experience persistent symptoms despite treatment, highlighting the need for new approaches that more comprehensively address the condition.<\/p>\n
\nBausch + Lomb has developed a first-in-class dual-action eye drop that combines 5% lifitegrast (the active ingredient in XIIDRA\u00ae<\/sup>) and perfluorohexyloctane (PFHO; the active ingredient in MIEBO\u00ae<\/sup>) into a single twice-daily treatment designed to address both ocular surface inflammation and tear evaporation \u2013 two of the primary underlying causes of dry eye disease.<\/p>\n
Study Design and Results<\/i><\/p>\n
\nA four-week, randomized, double-masked, parallel-group, active-controlled Phase 2 study enrolled 443 patients with dry eye disease (age 18 and older) across six arms: the dual-action eye drop, lifitegrast alone, PFHO alone and three vehicle masking controls. This was the first clinical study of the combination, and Day 29 was selected as the primary endpoint timepoint in the absence of prior human data on the timing of the combined treatment effect.<\/p>\n
\nThe study did not meet its primary endpoint of superiority over lifitegrast alone in reducing total corneal fluorescein staining (tCFS) from baseline at Day 29, although results numerically favored the dual-action eye drop (p=0.196). A pre-specified secondary analysis at Day 15 \u2013 a timepoint accepted by the Food and Drug Administration as a registrational primary endpoint for tCFS \u2013 showed a significant reduction in mean change from baseline tCFS for the dual-action eye drop versus lifitegrast alone (p=0.0007). At Day 15, 41.6% of patients treated with the dual-action eye drop achieved a \u22653-unit improvement in tCFS, compared with 18.8% of patients treated with lifitegrast alone and 31.6% treated with PFHO alone.<\/p>\n
\nThe safety profile in all three treatment groups was consistent with the established profiles of XIIDRA and MIEBO, with no new safety signals identified.<\/p>\n
Path to Phase 3<\/i><\/p>\n
\nThe data provide a clear path forward, and Bausch + Lomb will advance the dual-action eye drop into Phase 3 development with a primary endpoint at Day 15.<\/p>\n
\nNotably, the dual-action eye drop achieved these results with more than 50% less lifitegrast volume than XIIDRA and half the dosing frequency of MIEBO. The company believes this profile \u2013 a rapid treatment effect at a lower drug load and simplified dosing regimen \u2013 supports the design of Phase 3 studies to demonstrate superiority to both individual therapies. Details of the Phase 3 program will be shared in the coming months.<\/p>\n
\n\u201cThis was the first time this combination has been studied in humans, and it did exactly what a Phase 2 should do: demonstrated a rapid, robust treatment effect and told us precisely when to measure it,\u201d said Yehia Hashad, MD, executive vice president, R&D and chief medical officer, Bausch + Lomb. \u201cWith a pre-specified result of this strength at a registrationally accepted timepoint achieved with less drug than the individual therapies, and the ability to increase the dose based on an acceptable safety profile, we\u2019re advancing to Phase 3 with a clear design and high conviction.\u201d<\/p>\n
Ocular Surface Pain Program: Positive Phase 1b Results Confirm TRPV1 Mechanism in Humans and Support Continued Development of BL1332; Phase 2 Results Expected Within Next Few Months<\/b><\/p>\n
\nOcular surface pain is the leading reason patients seek care from eye care professionals and can affect individuals with dry eye disease, corneal disease and post-surgical complications. Despite its prevalence and impact on quality of life, there are currently no approved therapies specifically designed to target the underlying neurosensory pathways responsible for ocular surface pain, leaving many patients with limited treatment options.<\/p>\n
\nBausch + Lomb has developed BL1332, a first-in-class topical TRPV1 antagonist designed to target a key receptor involved in ocular pain signaling. Unlike therapies that primarily address associated signs or symptoms, BL1332 is intended to directly modulate the biological pathways that drive ocular surface pain. The investigational therapy is being evaluated as a potential treatment for multiple forms of ocular surface pain, including post-surgical, acute and chronic conditions. Based on its mechanism and clinical experience to date, the company believes BL1332 could support development across multiple ocular surface pain patient populations.<\/p>\n
Study Design and Results<\/i><\/p>\n
\nA Phase 1b study evaluated BL1332 0.30% ophthalmic solution in a capsaicin-induced ocular pain challenge model in healthy adult participants. The study met its primary endpoint, demonstrating a statistically significant reduction in pain intensity compared with vehicle and providing the first clinical confirmation that TRPV1 blockade can reduce ocular pain in humans beyond acute post-surgical pain. At five seconds following capsaicin challenge, BL1332-treated eyes experienced a 5.5-point reduction in mean pain intensity versus vehicle (p<0.0001). In exploratory analyses, 68.2% of BL1332-treated eyes achieved complete pain resolution compared with 0% of vehicle-treated eyes (p<0.0001), while no BL1332-treated eyes reported severe pain compared with 36.4% of vehicle-treated eyes receiving vehicle (p<0.01). Mean duration of pain following capsaicin challenge was also markedly shorter with BL1332 than with vehicle (1.6 versus 37.8 seconds; p<0.0001). The safety profile was acceptable and consistent with previous clinical experience, with no new safety signals identified.<\/p>\n
\nThe company believes these results validate the underlying mechanism of BL1332 and provide a foundation for ongoing studies designed to evaluate the therapy in patients experiencing clinically relevant ocular pain conditions.<\/p>\n
Path Forward<\/i><\/p>\n
\nBausch + Lomb is currently evaluating BL1332 in an ongoing Phase 2 study in patients experiencing pain following photorefractive keratectomy surgery, with topline results expected in the coming months. The study is intended to assess the potential of BL1332 in a real-world clinical setting and represents the next step in defining the therapeutic profile of the program.<\/p>\n
\nBeyond post-surgical pain, the company believes BL1332’s mechanism may have potential relevance across multiple ocular surface pain conditions, including pain associated with dry eye disease and other acute and chronic ocular disorders. Future development decisions will be informed by ongoing clinical results and discussions with regulatory authorities.<\/p>\n
\n\u201cThese results provide the first clinical evidence that targeting TRPV1 can meaningfully reduce ocular pain in humans that have not just undergone surgery,\u201d stated Hashad. \u201cThey also strengthen our confidence in the mechanism as we continue evaluating BL1332 in patients with clinically relevant pain conditions.\u201d<\/p>\n
Potential Financial Impact<\/b><\/p>\n
- Positive Phase 1b results for ocular surface pain candidate validate TRPV1 antagonist approach and strengthen confidence in ongoing Phase 2 study<\/i><\/li>\n
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