Fixed-Dose Carteolol/Latanoprost Combination: Tolerability and Efficacy
American Journal of Ophthalmology, November 2016
Monotherapy may be insufficient to lower intraocular pressure (IOP) for some patients with glaucoma, but therapy with 2 agents may be inconvenient and result in poor adherence. Yamamoto et al. reported results of 2 phase 3 randomized controlled trials in which a fixed-dose combination of 2% carteolol and 0.005% latanoprost, given as a single therapeutic (termed OPC-1085EL), was evaluated for safety and efficacy. OPC-1085EL was compared with carteolol and latanoprost administered as monotherapies or as separate concomitant therapies. The authors found that OPC-1085EL was well tolerated and reduced IOP more than the monotherapy and comparably to the concomitant therapy.
The trials were conducted at several centers in Japan and included patients with bilateral primary open-angle glaucoma or ocular hypertension. After a 4-week period with latanoprost or carteolol monotherapy, patients received 8 weeks of treatment with monotherapy, concomitant therapy, or OPC-1085EL applied daily in the morning.
In study 1, the mean reduction in baseline-adjusted IOP for the 113 patients treated with OPC-1085EL (2.9 mm Hg) was significantly better than for the 116 patients treated with latanoprost monotherapy (1.6 mm Hg). In study 2, the mean reduction in baseline-adjusted IOP was significantly better for OPC-1085EL (n = 76; 3.5 mm Hg) than for carteolol (n = 76; 1.6 mm Hg). IOP reduction in the 37 patients who received carteolol and latanoprost concomitantly was similar to that in recipients of OPC-1085EL. In both studies, OPC-1085EL was tolerated well and associated with only mild adverse drug reactions.
The authors concluded that OPC-1085EL is similar to concomitant therapy in terms of IOP-reducing efficacy but offers greater convenience. They noted that subsequent studies are needed to evaluate it for a longer duration, administered at other times of day, and in more diverse populations.
The original article can be found here.