Abstract
Purpose :
Low-dose (0.025%) brimonidine tartrate ophthalmic solution was approved by the FDA in 2017 under the brand name LUMIFY®. For some, frequent exposure of the ocular surface to the preservative benzalkonium chloride can induce or exacerbate existing ocular irritation. Thus, a preservative-free formulation of brimonidine tartrate ophthalmic solution 0.025% (BTOS-PF) has been developed. Here we describe results from a study evaluating the efficacy and safety of BTOS-PF vs LUMIFY.
Methods :
This was a multi-center, double-masked, randomized, active-controlled, parallel-group study in healthy adults (> 18 years of age) with ocular redness, conducted at 6 sites in the US. The study occurred over 5 weeks: Screening Visit (Day -28 to Day 1); Visit 1 (Baseline; Day 1); Visit 2 (Day 15 ± 2 days); Visit 3 (Day 29 + 2 days); and Visit 4 (Day 36 + 1 day). After the initial in-office dose at Visit 1, both agents were self-administered 4 times daily ~4 hours apart for a duration of 4 weeks. The primary efficacy endpoint was ocular redness score as evaluated by the Investigator prior to and at various timepoints after investigational drug instillation at Visit 1. Safety variables included physical exam including vital signs, adverse events (AEs; reported, elicited, and observed), BCVA at distance, slit lamp biomicroscopy, IOP, dilated ophthalmoscopy, and ocular rebound.
Results :
380 participants were randomized 1:1 to receive BTOS-PF or LUMIFY, of which 378 received at least one dose of investigational drug and form the safety population. A total of 48 treatment-emergent AEs (TEAEs) were reported by 37 (19.7%) of 188 subjects in the BTOS-PF group and 61 TEAEs reported by 39 (20.5%) of 190 subjects in the LUMIFY group. There were 20 ocular TEAEs in 16 (8.5%) subjects, and 28 non-ocular TEAEs in 23 (12.2%) subjects in the BTOS-PF group; and 21 ocular TEAEs in 20 (10.5%) subjects, and 40 non-ocular occurred in 22 (11.6%) subjects in the LUMIFY group. The majority of TEAEs were mild in severity. Rates of ocular rebound were low and similar between treatment groups, with 3 (1.8%) subjects in the BTOS-PF group and 1 (0.6%) subject in the LUMIFY group experiencing ocular rebound. Tolerability, as measured by drop comfort assessment and questionnaire, was comparable between groups.
Conclusions :
Overall, the safety profile of BTOS-PF was favorable and similar to that of LUMIFY.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.