Azarga receives positive CHMP opinion

October 13, 2008

Azarga (brinzolamide 1%/timolol 0.5% ophthalmic suspension; Alcon Laboratories) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), which recommends Azarga be granted marketing authorization from the European Medicines Agency (EMEA).

Azarga (brinzolamide 1%/timolol 0.5% ophthalmic suspension; Alcon Laboratories) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), which recommends Azarga be granted marketing authorization from the European Medicines Agency (EMEA). The drug has been found, during a head-to-head study, to be equally effective in lowering intraocular pressure (IOP) when compared with Cosopt (dorzolamide 2%/timolol 0.5% ophthalmic solution; Merck).

Philippe Denis, MD, PhD, professor and head, Department of Ophthalmology, Edouard Herriot Hospital, Lyon, France, and colleagues conducted the randomized, 12-month, multicentre study comparing the safety and efficacy of each drug combination. Both Azarga and Cosopt were found to have similar IOP-lowering effects, achieving IOP values of 16.7–18.8 mmHg and 16.9–19.4 mmHg, respectively. The adverse event profile of Azarga (transient blurred vision) was, in the opinion of the researchers, more acceptable to patients than that of Cosopt (localized stinging/burning sensation).

According to the CHMP report, the most common side effects of Azarga - which is indicated for IOP reduction in adults with open-angle glaucoma or ocular hypertension in whom monotherapy has proved unsuccessful - are blurred vision, eye irritation, eye pain, and foreign body sensation.