Bausch + Lomb is pushing ahead to a late-stage trial of its experimental dry eye treatment even though the drug failed to hit its target in a mid-stage study, according to Endpoints News.
The company told Endpoints exclusively on Monday that its dual-action drop missed the goal of its Phase 2 study. Despite that, CEO Brent Saunders characterized the result as a "better outcome than we had ever hoped," per the Endpoints report, and the company plans to move the candidate into a Phase 3 trial.
A bit of context on what those terms mean. Drug development runs in stages: Phase 2 studies are mid-stage tests designed to show whether a treatment actually works and at what dose, measured against a pre-declared "primary endpoint." Phase 3 trials are the large, expensive final studies that regulators typically require before approval. Missing a Phase 2 endpoint is usually the moment a company kills a program or goes back to redesign it, because the mid-stage data is what justifies spending on the much larger trial that follows.
That makes Saunders' framing the crux of the story. Companies that advance after a miss generally argue that something in the data — a subgroup, a secondary measure, a dosing signal — points to a design that would succeed in a bigger study. Endpoints' report does not detail which specific measures the drop fell short on beyond the missed goal, so the strength of that case is not yet public.
Dry eye disease is a common, chronic condition, and the treatment market has long been considered underserved, which is part of why drugmakers keep pursuing it.
This matters because it is a test of how much weight investors and regulators give a CEO's interpretation of a failed trial versus the trial's own stated benchmark — a judgment call that will cost real money either way.