Bausch + Lomb is moving two novel ophthalmic candidates into late-stage clinical development, targeting persistent gaps in dry eye care and ocular pain management.
A Single-Drop Combination Strategy for Dry Eye
Current prescription treatments for dry eye disease usually target either inflammation or evaporation, rarely both. Bausch + Lomb’s experimental twice-daily eye drop fuses the active components of XIIDRA® (lifitegrast) and MIEBO® (perfluorohexyloctane) into a single formula.
While the candidate’s Phase 2 trial failed to hit its primary endpoint at Day 29, it delivered strong results at Day 15—a benchmark recognized by the FDA for primary registration. At the two-week mark, 41.6% of patients using the dual drop showed significant corneal healing (≥3-unit tCFS improvement), outperforming lifitegrast (18.8%) and PFHO (31.6%) individually.
Crucially, the therapy achieved these outcomes using less than half the active lifitegrast volume of XIIDRA and half the daily applications required for MIEBO, without raising new safety concerns. Based on the Day 15 efficacy, Bausch + Lomb will push the program into Phase 3 testing using the earlier timeline as its primary benchmark.
Targeted Relief for Ocular Pain
The company is also tackling ocular surface pain—a widespread issue with no targeted therapies approved to block its root nerve pathways. Its novel compound, BL1332, acts as a TRPV1 antagonist to directly interrupt pain signals sent to the brain.
In a Phase 1b trial using a capsaicin challenge model, BL1332 0.30% demonstrated swift pain relief:
– Pain Reduction: Reduced average pain scores by 5.5 points compared to vehicle.
– Full Resolution: Delivered complete pain relief in 68.2% of treated eyes, compared to 0% in the control group.
– Duration: Cut the duration of post-challenge pain from nearly 38 seconds down to under two seconds.
The trial marks the first human clinical proof that blocking TRPV1 can suppress ocular pain beyond basic post-surgical contexts. A Phase 2 study evaluating BL1332 in patients recovering from PRK eye surgery is currently underway, with initial data anticipated in the coming months.
