Objective:

To advance two first-in-class ocular surface therapies: a dual-action dry eye drop and the TRPV1 antagonist BL1332, based on recent clinical trial results.

Approach:

• Dual-action dry eye drop: Combines 5% lifitegrast with perfluorohexyloctane (PFHO) in a single formulation for dry eye disease.
• BL1332: A topical TRPV1 antagonist evaluated in a Phase 1b study for ocular pain signaling.

Key Findings:

• The dual-action therapy did not meet its primary endpoint of superiority over lifitegrast alone in reducing total corneal fluorescein staining (tCFS) at Day 29.
• A significant reduction in mean tCFS change from baseline was observed at Day 15 compared to lifitegrast alone (p=0.0007), with 41.6% of patients achieving a three-unit or greater improvement in tCFS.
• BL1332 met its primary endpoint in a Phase 1b study, showing a 5.5-point greater reduction in mean pain intensity than vehicle.

Interpretation:

The dual-action therapy demonstrated a rapid treatment effect at Day 15, and BL1332 showed potential for reducing ocular pain.

Limitations:

• The primary endpoint for the dual-action therapy was not met at Day 29.
• Further evaluation is needed for both therapies in larger populations to confirm efficacy.

Conclusion:

Bausch + Lomb plans to advance the dual-action therapy to Phase 3, using Day 15 as the primary endpoint, and continue evaluating BL1332 in Phase 2 studies.

Sources:

• Bausch + Lomb