Bausch + Lomb's Lumify phase 3 data published

Executive Summary

• Bausch + Lomb announced the publication of Phase 3 clinical data confirming that Lumify Preservative-Free Redness Reliever Eye Drops are statistically non-inferior to the original Lumify formula in reducing ocular redness.
• The company officially launched Lumify Preservative-Free eye drops in the U.S. in June 2025, targeting consumers with eye sensitivities or those at increased risk of ocular surface disease.
• The study demonstrated a favorable safety profile for the preservative-free formulation, with low incidence of side effects such as rebound redness and loss of efficacy when used as directed.

Key Details

• Study Design: Randomized, active-controlled, multicentre study involving 380 participants with ocular redness.
• Protocol: Participants received either Lumify Preservative-Free or Lumify (single drop, four times daily) for four weeks.
• Primary Objective: Demonstrate non-inferiority of Lumify Preservative-Free to Lumify in reducing ocular redness.
• Primary Endpoint: Investigator-assessed ocular redness score at eight timepoints from 5 to 240 minutes after administration on Day 1.
• Results:
  • Met primary objective: Lumify Preservative-Free was statistically non-inferior to Lumify.
  • Day 1 analysis of all 11 timepoints (1 to 480 minutes post-administration) supported these findings.
  • Secondary efficacy endpoints at 1, 360, and 480 minutes showed similar performance between the two formulations.
• Safety Profile:
  • Overall safety was favorable and comparable to Lumify.
  • Occurrence of ocular treatment-emergent adverse events was similar in both groups.
  • Low incidence of side effects like rebound redness and loss of efficacy over time.
• Product Details:
  • Formulated with low-dose brimonidine tartrate 0.025%.
  • Selectively targets eye redness with lower risk of rebound redness compared to traditional redness relievers.
  • Launch date in the U.S.: June 2025.

Notable Quotes

• "Since launching in 2018, Lumify has been the No. 1 doctor-recommended redness reliever brand... This study demonstrates that our new Lumify preservative-free eye drops reduce redness quickly and are just as safe and effective as the original Lumify, providing a needed option for patients with eye sensitivities." — John Ferris, President, Consumer, Bausch + Lomb
• "The results show that Lumify preservative-free is a well-tolerated alternative option for consumers with ocular redness who have sensitivities to preservatives or are at increased risk of ocular surface disease." — Melissa Toyos, MD, Partner, Toyos Clinic