FDA approves Alcon Research's eye infection treatment
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.