EU Panel Backs Simbrinza for Glaucoma, Ocular Hypertension

Megan Brooks

Disclosures

May 23, 2014

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has endorsed brinzolamide and brimonidine tartrate eyedrops (Simbrinza, Alcon) for the treatment of open-angle glaucoma or ocular hypertension in patients for whom monotherapy provides insufficient reduction of intraocular pressure (IOP).

The benefits with Simbrinza are its ability to lower the ocular pressure by means of the 2 different mechanisms of action, the EMA notes in a statement.

Brinzolamide reduces ocular pressure by a direct antagonist activity on carbonic anhydrase within the ciliary epithelium, thereby decreasing the production of aqueous humor. Brimonidine targets the α2-receptor in the ciliary epithelium, ultimately resulting in suppression of aqueous humor formation, they explain.

The most common adverse effects are ocular (topical) reactions, including ocular hyperemia, ocular discomfort, blurred vision, and ocular allergy. A pharmacovigilance plan for Simbrinza will be implemented as part of the marketing authorization.

On the basis of the quality, safety, and efficacy of data submitted, CHMP considers there to be a favorable benefit-to-risk balance for Simbrinza and therefore recommends the granting of the marketing authorization, the EMA said.

Detailed recommendations for the use of Simbrinza will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the European Commission grants marketing authorization.

The US Food and Drug Administration approved Simbrinza for primary open-angle glaucoma or ocular hypertension in April 2013, as reported by Medscape Medical News.

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