PURPOSE: Topical over-the-counter ocular vasoconstrictors can relieve ocular redness, but sustained adrenergic agonist use has raised concerns about rebound redness, tachyphylaxis/loss of effect, and overuse or misuse. Brimonidine tartrate 0.025% ophthalmic solution (BTOS; LUMIFY®) is a selective α2-adrenergic receptor agonist, differing from α1 or mixed α1/α2 vasoconstrictors such as tetrahydrozoline and naphazoline. Because of its α2 selectivity, BTOS is hypothesized to have a lower propensity for rebound redness, tachyphylaxis, and related overuse/misuse. This analysis summarized current pharmacovigilance data for BTOS and newly marketed LUMIFY® Preservative Free (BTOS-PF).

METHODS: Post-marketing data from a periodic safety report covering 09 Dec 2024–08 Dec 2025 were reviewed; clinical trial safety data were excluded. Sales-based exposure was expressed as patient-treatment days (PTDs). MedDRA preferred terms and safety topics potentially consistent with rebound redness, tachyphylaxis/loss of effect, or overuse/misuse were reviewed, including rebound effect, ocular hyperemia, drug ineffective/lack-of-effect terms, symptom recurrence, drug tolerance, off-label use, overdose, drug abuse, drug misuse, and medication-error/product-use terms.

RESULTS: During the interval assessed, total exposure was 828,306,265 PTDs: 780,758,324 for BTOS and 47,547,941 for BTOS-PF. BTOS-PF was approved in April 2024 and marketed from May 2025; therefore, this represents the first real-world safety reporting interval for BTOS-PF. For rebound effect with long-term use, no cases were reported. During the interval, 93 lack-of-efficacy cases were reported (73 BTOS; 20 BTOS-PF), representing a reporting rate of approximately 0.11 lack-of-efficacy cases per million PTDs. Off-label-use reports included 54 non-serious cases (48 BTOS; 6 BTOS-PF). Misuse was infrequently reported: 7 non-serious cases (4 BTOS; 3 BTOS-PF), coded as intentional product use issue or intentional product misuse. Two non-serious accidental-overdose cases were reported with BTOS; no drug-abuse cases were reported during the interval. No trend, signal, or new safety information affecting the benefit-risk profile was identified for these topics.

CONCLUSION: Across substantial real-world exposure, including initial post-launch experience with BTOS-PF, pharmacovigilance data showed low reporting of events potentially suggestive of rebound redness, tachyphylaxis/loss of effect, or overuse/misuse. These findings align with the α2-selective mechanism-of-action hypothesis and with LUMIFY® clinical trial observations of low ocular rebound redness and no apparent loss of effectiveness.