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Abstract #92583 Published in IGR 22-1
Efficacy and safety of fixed-combination brimonidine tartrate/timolol maleate in primary open-angle glaucoma, including normal-tension glaucoma
Park SW; Kim JM; Lee JW; Maglambayan J; Simonyi S; Park KHJapanese Journal of Ophthalmology 2021; 65: 295-305
PURPOSE: To assess the 12-month efficacy and safety of fixed-combination brimonidine tartrate 0.2%/timolol maleate 0.5% (FCBT) with or without bimatoprost 0.01% (BIM) in primary open-angle glaucoma (POAG), including normal-tension glaucoma (NTG). STUDY DESIGN: Prospective, multicenter, open-label study. METHODS: FCBT was self-administered twice daily after applicable washout (study eye). Intraocular pressure (IOP) was measured at baseline and months 1, 3, 6, 9, and 12. BIM could be added for IOP ≥ 21 mmHg, IOP reduction from baseline < 20%, or the investigator deemed it necessary. Primary endpoint: mean (11-a.m.) month-12 IOP change from baseline. Secondary endpoints included mean IOP changes from baseline at other visits, median time to achieving and patients (%) achieving target IOP reduction with FCBT, and visual field (VF) progression rate over 12 months. Safety was assessed at each visit. RESULTS: Of 118 eyes with POAG (NTG, n = 93), 87 used FCBT; 31 required FCBT + BIM. Mean IOP changes from baseline (16.8 and 15.3 mmHg) to month 12 were - 4.1 mmHg (FCBT, n = 62) and - 3.5 mmHg (FCBT + BIM, n = 15), respectively (both P < 0.0001). Patients who achieved target IOP reduction with FCBT did so in 1 month (median). VF progression rates were 0.17%/year (FCBT, P = 0.8367) and - 0.08%/year (FCBT + BIM, P = 0.9410). Ocular treatment-emergent adverse events occurred in 42.5% (FCBT) and 71.0% (FCBT + BIM) of patients; most were mild and included ocular hyperemia (9.2% and 41.9%, respectively). CONCLUSIONS: Despite low mean baseline IOP, ≥ 20% IOP reduction from baseline persisted over 12 months with FCBT and FCBT + BIM, without clinically significant VF progression. Tolerability was consistent with reported drug safety profiles.
Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, Korea.
Full articleClassification:
11.13.3 Betablocker and brimonidine (Part of: 11 Medical treatment > 11.13 Combination therapy)
9.2.4 Normal pressure glaucoma (Part of: 9 Clinical forms of glaucomas > 9.2 Primary open angle glaucomas)
