Alcon Laboratories' ophthalmic steroid product Vexol (rimexolone 1% solution) has been approved in the USA for the treatment of post-operative inflammation following ocular surgery and treatment of anterior uveitis. The product was given a priority rating by the Food and Drug Administration, which approved it just seven months after the application was filed.
Two controlled clinical trials submitted in support of the application found that the drug is effective in treating anterior chamber inflammation following cataract surgery, and is as effective as 1% prednisolone in reducing uveitic inflammation. The approval letter notes that any advertisement or promotional labeling for Vexol will be considered false and misleading if it promotes steroid class uses other than the approved indications.
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