Bausch + Lomb's LUMIFY Preservative Free Eye Drops Demonstrate Non-Inferiority in Phase 3 Trial
核心洞察
Bausch + Lomb (搜索)'s LUMIFY Preservative Free eye drops met the primary endpoint in a phase 3 study, demonstrating statistical non-inferiority to original LUMIFY drops in reducing ocular redness (搜索).
The randomized, active-controlled study of 380 participants showed comparable efficacy and safety profiles between preservative-free and original formulations over 4 weeks of treatment.
The FDA-approved preservative-free formulation provides an alternative for patients with eye sensitivities while maintaining the same fast-acting brimonidine tartrate 0.025% formula.
Bausch + Lomb (搜索) has successfully launched LUMIFY Preservative Free redness reliever eye drops in the United States following positive results from a phase 3 clinical trial that demonstrated the preservative-free formulation is statistically non-inferior to the original LUMIFY drops in reducing ocular redness (搜索). The FDA approved the preservative-free version in April 2024.
Clinical Trial Results Demonstrate Efficacy
The randomized, active-controlled, multicenter study published in Ophthalmology and Therapy included 380 participants with ocular redness (搜索) who received either LUMIFY Preservative Free or original LUMIFY drops administered as a single drop four times daily for four weeks. The primary efficacy endpoint measured investigator-assessed ocular redness scores at eight timepoints from 5 minutes to 240 minutes after drop administration on day 1.
"The 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," said John Ferris, president of Consumer at Bausch + Lomb (搜索).
The study met its primary objective, with day 1 analysis of all 11 timepoints from 1 minute to 480 minutes post-administration supporting the non-inferiority findings. Additional secondary efficacy endpoint data from 1 minute, 360 minutes, and 480 minutes post-administration demonstrated that LUMIFY Preservative Free drops perform similarly to the original LUMIFY drops.
Safety Profile and Patient Experience
The overall safety profile of the preservative-free drops was favorable and comparable to original LUMIFY, with a low incidence of side effects when used as directed. Rates of ocular rebound redness were reported in 1.8% of the preservative-free group compared to 0.6% in the LUMIFY group. Compliance rates were high in both treatment groups, with 96.8% for preservative-free and 97.9% for original LUMIFY.
Patient comfort assessments showed similar results between formulations. In the preservative-free and LUMIFY groups, drops were described as "comfortable" by 50% and 51.1% of participants respectively, "refreshing" by 20.2% and 20% respectively, and "cool" by 14.4% and 11.6% respectively.
"At visit 1, there was no significant difference between treatment groups in the number of participants achieving total clearance at any time of the 11 timepoints from 1 to 480 minutes post-instillation, 2 participants from each treatment group had total clearance of ocular redness (搜索)," stated study authors led by Melissa Toyos, MD, partner at Toyos Clinic in Nashville, Tennessee.
Market Position and Availability
LUMIFY eye drops were initially introduced by Bausch + Lomb (搜索) in 2018 and remain the only over-the-counter redness relievers that selectively target eye redness with a lower risk of rebound redness and loss of efficacy when used as directed. The brand has become the number one doctor-recommended redness reliever brand, known for delivering noticeable results in one minute and lasting up to eight hours.
"Consumers often say how amazed they are at the difference our original LUMIFY makes to their eyes, with over 50,000 five-star reviews as proof," said Ferris. "LUMIFY Preservative Free brings that same fast-acting formula to those with sensitive eyes — delivering a visibly brighter, whiter look in just 60 seconds."
LUMIFY Preservative Free is currently available in single-use vials at most US retailers nationwide, including Walmart, Target, CVS, Walgreens, Rite Aid, and Amazon, with a manufacturer's suggested retail price of $26.99 and updated premium packaging.
Clinical Implications
The preservative-free formulation addresses an important unmet need for patients with eye sensitivities who may experience adverse reactions to preservatives commonly found in eye drops. "The results show that LUMIFY Preservative Free is a well-tolerated alternative option for consumers with ocular redness (搜索) who have sensitivities to preservatives or are at increased risk of ocular surface disease (搜索)," said Toyos.
Both formulations contain low-dose brimonidine tartrate 0.025% that works to relieve redness of the eye due to minor eye irritations (搜索). The preservative-free version maintains the same efficacy profile while eliminating potential preservative-related complications for sensitive patients.