FDA approves Alcon Research's eye infection treatment

2/20/2009

ROCKVILLE, Md. The Food and Drug Administration has approved a new drug for treating eye infections, agency records show.

The FDA approved Alcon Research's TobraDex ST (tobramycin 0.3% and dexamethasone 0.5% ophthalmic suspension). The drug treats steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial eye infection exists or is a risk, according to the FDA's approval letter. 

The approval marks Hunenberg, Switzerland-based Alcon's third in the past three months. On Dec. 23, the FDA approved its +3.0 diopter add power AcrySof IQ ReSTOR intraocular lens, used for cataract surgery in patients with presbyopia. Earlier that month, the European Medicines Agency ­ the European Union's counterpart to the FDA ­ approved its Azarga (brinzolamide 10 mg per milliliter and timolol 5 mg per milliliter) ophthalmic suspension, for treating symptoms related to glaucoma and ocular hypertension. 

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