Inspire receives FDA approval of azithromycin for treatment of bacterial conjunctivitis

Inspire Pharmaceuticals Inc. announced that the FDA has approved azithromycin ophthalmic solution 1% (AzaSite) for the treatment of bacterial conjunctivitis. The company anticipates the launch of azithromycin in the third quarter of 2007 and for the product to generate $30 million to $45 million in sales in the 2008 calendar year based on current manufacturing and commercial plans.

Azithromycin will offer patients a reduced dosing regimen compared with other available products for bacterial conjunctivitis, according to the company. The recommended dosing regimen for azithromycin is one drop (twice a day) for 2 days followed by one drop (once a day) for the next 5 days, for a total of nine drops in the affected eye.

In two phase III clinical studies, azithromycin met the primary efficacy endpoint of clinical resolution in patients with confirmed bacterial conjunctivitis. Clinical resolution was defined as the absence of ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection. The most common adverse event in patients receiving the medication was eye irritation, which occurred in 1% to 2% of patients.

Inspire Pharmaceuticals acquired exclusive rights to commercialize azithromycin for ocular infections in the United States and Canada from InSite Vision Inc. in February.

For more information, visit Inspire Pharmaceuticals at Booth 1005.