AzaSite production increased to combat erythromycin ophthalmic ointment shortage

Sep 15 2009

InSite Vision Incorporated (OTCBB: INSV) today announced that Inspire Pharmaceuticals, its commercial partner for AzaSite® (azithromycin ophthalmic solution) 1% in the U.S and Canada, has committed to increasing production of AzaSite in response to the manufacturing supply shortage of erythromycin ophthalmic ointment (0.5%).

Erythromycin ophthalmic ointment is approved for prophylaxis of ophthalmia neonatorum, a form of bacterial conjunctivitis that may be contracted by newborns during delivery. It is the only product approved for this indication commercially available in the United States. Recently, the U.S. Food and Drug Administration (FDA) placed erythromycin ophthalmic ointment on the FDA’s Drug Shortage list. The Centers for Disease Control and Prevention (CDC), the U.S. Department of Health and Human Services, the American Academy of Ophthalmology and the FDA all recommend that existing supplies of erythromycin ophthalmic ointment be reserved for the treatment of neonatal prophylaxis use.

These organizations are encouraging healthcare professionals to use alternative drugs, including AzaSite, for the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to erythromycin, as well as for treatment of post-surgical and posttraumatic events. In addition, the CDC has recommended AzaSite as an acceptable substitute for neonatal prophylaxis use where erythromycin ophthalmic ointment is not available. AzaSite has not been approved by the FDA for the treatment of prophylaxis of ophthalmia neonatorum and no clinical trials have been conducted using AzaSite in this population. This recommendation was based on available AzaSite data on pharmacology and gonococcal microbiologic sensitivity.

Approved by the FDA in 2007 for the treatment of bacterial conjunctivitis, AzaSite requires the fewest doses per course of treatment of available ocular antibiotic products in the U.S. AzaSite is formulated with InSite Vision’s patented DuraSite® technology to enhance the retention time of the therapeutic agents on the surface of the eye leading to increased ocular tissue concentrations. InSite Vision and Inspire Pharmaceuticals entered into a licensing agreement for the commercialization of AzaSite in February 2007.