PURPOSE: Brimonidine tartrate ophthalmic solution 0.025% (Lumify®; BTOS) is a selective α2-adrenergic receptor agonist that provides rapid ocular redness relief with very low risk of rebound redness or tachyphylaxis. A new BTOS formulation (BTOS-HA) has been developed containing hyaluronic acid, a natural component in tears that helps to keep the eye moisturized and protects it from mechanical stress during blinking. A Phase 3 study established the non-inferiority of BTOS-HA to BTOS via its primary endpoint of redness reduction from 5–240 minutes after instillation. This analysis further explores the activity of the novel BTOS-HA.

METHODS: Adults with investigator-rated ocular redness >1 in both eyes (0–4 scale) received BTOS-HA 4 times daily for 4 weeks (N=289). Investigator-rated redness was assessed before and for 10 hours after first instillation on Day 1, with additional assessments on Days 15 and 29. Safety included ocular and non-ocular treatment-emergent adverse events (TEAEs), best-corrected visual acuity, slit-lamp biomicroscopy, intraocular pressure, dilated fundus examination, and rebound redness through Day 36.

RESULTS: On Day 1, after a single BTOS-HA instillation, mean (SD) redness score decreased from 2.27 (0.53) pre-instillation to 1.58 (0.73) at 30 seconds (mean change -0.69; p< 0.0001) and 0.95 (0.67) at 1 minute. Mean scores were < 0.5 from 5 through 120 minutes (0.29 to 0.44), and statistically significant reduction persisted at 10 hours (1.82 [0.74]; mean change -0.45; p< 0.0001). >50% total clearance was observed beginning at 5 minutes through 60 minutes. Ocular TEAEs occurred in 19/289 (6.6%) and non-ocular TEAEs in 14/289 (4.8%); only instillation-site irritation (5/289, 1.7%) and urinary tract infection (3/289, 1.0%) occurred in ≥1% of BTOS-HA-treated subjects. All ocular TEAEs were mild or moderate. One serious non-ocular TEAE occurred and was not treatment related. Investigator-assessed rebound redness was low: 6/277 (2.2%). No clinically meaningful safety findings were observed for best-corrected visual acuity, intraocular pressure, slit-lamp biomicroscopy, or dilated fundus examination.

CONCLUSION: BTOS-HA provided rapid redness reduction within 30 seconds of first instillation, with mean redness scores < 0.5 from 5 to 120 minutes and statistically significant reduction maintained through 10 hours. Over 4 weeks of dosing, BTOS-HA was well tolerated, with infrequent ocular and non-ocular TEAEs and low rebound redness.