Bausch + Lomb announced in a press release that it has developed BL1332, a first-in-class topical TRPV1 antagonist designed to target a key receptor involved in ocular pain signaling. The investigational therapy is being evaluated as a potential treatment for multiple forms of ocular surface pain, including postsurgical, acute, and chronic conditions. Based on its mechanism and clinical experience to date, the company said BL1332 could support development across multiple ocular surface pain patient populations.

A phase 1b study evaluated BL1332 0.30% ophthalmic solution in a capsaicin-induced ocular pain challenge model in healthy adult participants. According to the company, 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 postsurgical pain.

At 5 seconds following capsaicin challenge, BL1332-treated eyes experienced a 5.5-point reduction in mean pain intensity vs 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 shorter with BL1332 than with vehicle (1.6 vs 37.8 seconds; P<0.0001). The safety profile was acceptable and consistent with previous clinical experience, with no new safety signals identified, the company noted in the press release. 

Bausch + Lomb said 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. The company 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. Bausch + Lomb said 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.

Beyond postsurgical pain, Bausch + Lomb said 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, the company said in the press release.