InSite Vision submits azithromycin NDA

Alameda, CA-InSite Vision Inc. submitted a New Drug Application (NDA) to the FDA for a topical 1% azithromycin formulation (Aza-Site) for the treatment of bacterial conjunctivitis.

Alameda, CA-InSite Vision Inc. submitted a New Drug Application (NDA) to the FDA for a topical 1% azithromycin formulation (Aza-Site) for the treatment of bacterial conjunctivitis. The formulation is paired with InSite's patented DuraSite ophthalmic drug-delivery system, which increases ocular retention of the drug.

Two phase III studies showed that the formulation, through this delivery system, was safe, well tolerated, and efficacious in the treatment of bacterial conjunctivitis.