Approval sought for ISTA anti-inflammatory drug

Irvine, CA-ISTA Pharmaceuticals is seeking FDA approval to start phase III studies of a new combination ophthalmic product containing tobramycin and prednisolone acetate to treat steroid-responsive inflammatory ocular conditions that risk bacterial infection.

The company filed an investigational new drug application with the FDA in April.

If approved, the product would compete in the antibiotic steroid segment of the $400 million U.S. topical ophthalmic anti-inflammatory market.