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Ista seeks approval for eye drug

Ista Pharmaceuticals has filed a new drug application with the FDA for its investigational combination drug T-Pred as a treatment for inflammatory ocular conditions.

The drug combines the ophthalmic steroid prednisolone acetate with the antibiotic solution prednisolone. Both compounds are commonly prescribed by ophthalmologists, according to Ista Pharmaceuticals, a specialty pharmaceutical company focused on the development and commercialization of unique and uniquely improved ophthalmic products.

“If approved, we believe T-Pred will offer patients a powerful new treatment combining fast anti-inflammatory relief with excellent antibacterial coverage,” stated Dr Vicente Anido, president and CEO of Ista Pharmaceuticals. “Pending acceptance and timely approval of our T-Pred new drug application (NDA) submission, we anticipate a potential launch of this product in mid-2007.”

The company estimates 2005 sales in the US topical ophthalmic anti-inflammatory market to exceeded $400 million, with total prescriptions of approximately 8.8 million.