Bausch + Lomb has come up short in a phase 2 trial, testing its combination of dry eye disease drugs Xiidra and Miebo. While the study missed its primary endpoint, the Ontario eye care specialist has seen enough promise in the combo to advance it to phase 3 development, it said on Tuesday.
In the phase 2 study, which included 441 dry eye disease patients, investigators evaluated the combination treatment versus the individual performances of Xiidra and Miebo, plus three vehicle masking controls. At Day 29, while the dual-action eye-drop showed numerical superiority over Xiidra in reducing total corneal fluorescein staining (tCFS), it did not achieve the primary endpoint.
The silver lining came in a pre-specified secondary analysis at Day 15 which showed the combo provided a significant reduction in tCFS versus Xiidra alone. At the interval, 41.6% of patients treated with the dual-action eye drop achieved a 3-unit or greater improvement in tCFS, compared with 18.8% of patients treated with Xiidra alone and 31.6% of those on Miebo alone.
The safety profile of the combo remained consistent with the individual profiles of Xiidra and Miebo, with no new signals identified.
Bausch + Lomb said that the results “provide a clear path forward,” noting that the rapid treatment effect was achieved at a “lower drug load and a simplified dosing regimen.”
Bauch + Lomb’s R&D and chief medical officer Yehia Hashad, M.D., said in a release that that study “did exactly what a phase 2 should do,” as it “demonstrated a rapid, robust treatment effect and told us precisely when to measure it.”
“With 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’re advancing to phase 3 with a clear design and high conviction,” Hashad added.
Xiidra, which was approved a decade ago, is a lymphocyte function-associated antigen-1 (LFA-1) antagonist that was originally developed by SARcode Bioscience, before it changed hands to Shire in 2015, Novartis in 2019 and finally Bausch + Lomb in 2023 in a $2.5 billion acquisition.
Miebo, which was approved in 2023, is a semifluorinated alkane. It is administered four times a day, as opposed to twice daily for Xiidra. While Miebo reduces excessive tear evaporation, Xiidra addresses ocular surface inflammation. These are the two main causes of dry eye disease.
Sales have scaled up rapidly for Miebo, reaching $410 million in 2025. In the first half of this year, Miebo generated revenue of $167 million, compared to $173 million for Xiidra. The pair’s combined sales were up 27% in the first half compared to the first half of 2025.
Bausch + Lomb also revealed positive phase 1b results for its investigational treatment BL1332, a TRPV1 antagonist which demonstrated a statistically significant reduction in pain intensity compared with vehicle. It is the first clinical confirmation that TRPV1 blockade can reduce ocular pain in humans beyond acute post-surgical pain, the company said.
The results validate the underlying mechanism of BL1332, the company added, providing a “foundation for ongoing studies designed to evaluate the therapy in patients experiencing clinically relevant ocular pain conditions.”
Bausch + Lomb is currently evaluating BL1332 in an ongoing phase 2 study in patients who have undergone photorefractive keratectomy surgery.
In November of 2025, the company estimated peak sales for the dry-eye disease combo at $700 million and for BL1332 at $1.4 billion, assuming it can be successfully developed for multiple ocular surface pain conditions.