Bausch + Lomb had an investigational eye drop that failed to reach its primary efficacy endpoint in a mid-stage trial of dry eye disease, but the drug nonetheless has been moved into Phase 3 development because of what Bausch + Lomb’s head of clinical affairs, Yehia Hashad, described as a “rapid, robust treatment effect.”
Trial Design and Combination Active Ingredients
The active ingredient in Xiidra is 5% lifitegrast, which is one of Bausch + Lomb’s dry eye disease therapies, while perfluorohexyloctane (PHFO) is a product sold by the pharma, also used as an active ingredient in its dry eye disease treatment. The Phase 2 study was designed to compare the experimental drop (twice daily) with Xiidra alone, PHFO alone, and three vehicle controls. A total of over 440 patients enrolled who had dry eye disease.
Efficacy Results
Results, revealed in a press release, showed that the investigational eye drop failed to significantly improve eye damage, as measured by total corneal fluorescein staining (tCFS), at day 29 versus Xiidra alone—though Bausch + Lomb detected an effect that “numerically favored” the investigational combination.
In addition, a pre-specified secondary analysis suggested that there was a treatment benefit at 15 days in the groups of patients receiving the candidate plus Xiidra compared to those receiving Xiidra alone. This is the “a timepoint accepted by the Food and Drug Administration as a registrational primary endpoint for tCFS,” the company said.
“This was the first time this combination has been studied in humans, and it did exactly what a Phase 2 should do – it showed us a quick and strong treatment effect, and it told us when to measure,” said Hashad, executive vice president of R&D at Bausch + Lomb, in a statement.
Revised Phase 3 Strategy and Trial Protocols
The results of this secondary analysis have led Bausch + Lomb to advance into Phase 3 development of the candidate, using a primary endpoint analysis at day 15 instead. The study will be repeated in late-stage to compare the results of the dual-action eye drop with its individual components. Additional information on the design will be shared “in the coming months,” as will the study’s timeframe, said the company.
Bausch + Lomb said in November last year Phase 3 data could be available in 2028 and they expected the dual-action drops to be available in 2029, if approved. The company at the time also predicted peak sales around $700 million for the drug, which the company reiterated.
Bausch + Lomb is advancing an investigational dual-action eye drop for dry eye disease into Phase 3 development despite the treatment missing its primary endpoint in a Phase 2 study. The company said a prespecified analysis at an earlier timepoint showed a statistically significant treatment effect, supporting the decision to continue development.
Bausch + Lomb Phase 2 Study
The Bausch + Lomb Phase 2 trial enrolled 443 adults with dry eye disease. The study evaluated a twice-daily combination of 5% lifitegrast and perfluorohexyloctane, the active ingredients in Xiidra and Miebo, respectively.
Bausch + Lomb Sees Commercial Potential
The investigational eye drop combines two established active ingredients with different mechanisms of action. One component is designed to reduce inflammation associated with dry eye disease, while the other helps address excessive tear evaporation by improving the stability of the tear film.
This combination approach is intended to address multiple contributors to dry eye symptoms rather than focusing on a single mechanism.
Why the Phase 2 Results Matter
Although the study did not meet its primary endpoint at Day 29, the earlier Day 15 findings provided a different perspective. The company reported a statistically significant improvement in corneal staining at that earlier measurement point.
Clinical trials often evaluate several timepoints because treatment effects can develop at different rates. However, results from an earlier timepoint do not guarantee success in a larger Phase 3 study.
What Phase 3 Could Show
The planned Phase 3 program is expected to provide a larger and more definitive assessment of the treatment’s effectiveness and safety.
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