Bimatoprost/timolol fixed combination versus latanoprost in treatment-naïve glaucoma patients at high risk of progression: a pilot study

Abstract

ObjectiveTo compare a fixed combination of 0.03% bimatoprost and 0.5% timolol (BTFC) with latanoprost monotherapy (LM) in treatment-naïve patients with open-angle glaucoma (OAG) and risk factors for glaucomatous progression.MethodsPatients were enrolled at 15 sites in Spain and Portugal, and were randomized 1:1 to BTFC or LM. Patients instilled one drop of medication once per day at 8 pm for 12 weeks. The primary outcome was change in intraocular pressure (IOP) at 12 weeks.ResultsOf 81 patients enrolled, 43 were randomized to BTFC and 38 to LM. Mean (SD) change in IOP from baseline to 12 weeks was significantly greater for BTFC than for LM: −13.5 mmHg (4.48) versus −11.4 mmHg (3.19), respectively (P=0.003). Similarly, at 12 weeks, significantly more BTFC patients than LM patients had IOP reductions of ≥40% (74.4% versus 47.4%, P=0.015) or ≥50% (46.5% versus 15.8%, P=0.003). Adverse events were more frequent with BTFC than with LM (33 versus 13 events), but most were mild in severity. The only serious adverse event (colon cancer) was adjudged unrelated to the study medication.ConclusionBTFC was effective and well tolerated in treatment-naïve patients with OAG at high risk of progression.

Fixed-combination treatments for intraocular hypertension in Chinese patients – focus on bimatoprost-timolol

“…Several clinical studies conducted in European countries have reported the superior efficacy of BTFC compared with bimatoprost monotherapy 25 , 33 – 35 or latanoprost monotherapy. 32 , 36 There has been no comparative study conducted in the People’s Republic of China on the efficacy of BTFCs against PGA monotherapies to date.…”