A triple fixed-combination of bimatoprost, brimonidine, and timolol (TFC) in patients with glaucoma or ocular hypertension (OHT) is an alternative therapeutic option for patients whose intraocular pressure (IOP) is not sufficiently controlled with fixed-combination or unfixed brimonidine and timolol therapy (dual-combination therapy), according to a study.
In this multicenter, open-label, phase 3 study, patients with an IOP >18 and <34 mmHg in at least 1 eye after receiving 4-8 weeks of dual-combination therapy twice daily and were switched to treatment with TFC twice daily for 12 weeks. IOP was measured at Hours 0, 2, and 8 at Weeks 4, 8, and 12.
Primary efficacy was mean diurnal IOP change from baseline in the study eye at Week 12 (modified intent-to-treat [mITT] population). Sensitivity (per-protocol [PP] population) and subgroup (≤65 vs >65 years) analyses were performed
There were 121 patients in the mITT/safety population, of which 109 completed the study, and 103 patients in the PP population, of which 94 completed the study.
The mean diurnal change in IOP from dual combination-treated baseline to week 12 was statistically significant (P<0.001) with TFC in the mITT (-3.98 mmHg) and PP (-4.22 mmHg) populations.
The most frequently reported treatment-related adverse events were conjunctival hyperemia in 14% and dry eye in 4.1% of patients. Overall, 5.8% of the patients discontinued treatment due to ocular adverse events.
Reference
Menon MG, Goodkin ML. Triple Fixed-Combination Bimatoprost/Brimonidine/Timolol in Glaucoma and Ocular Hypertension in India: A Multicenter, Open-Label, Phase 3 Study. Clin Ophthalmol. 2022;16:3559-3569. doi: 10.2147/OPTH.S369626. PMID: 36274674; PMCID: PMC9582300.
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