INSITE VISION ANNOUNCES POSITIVE RESULTS FROM EYE DRUG TRIAL

InSite Vision has announced top-line results from its Phase I safety study of AzaSite Plus (ISV-502), a combination antibiotic/corticosteroid product formulated in DuraSite.

AzaSite Plus combines azithromycin and dexamethasone in DuraSite, which is InSite Vision's drug delivery system for topical ophthalmic indications. It provides the broad antibacterial coverage of AzaSite. AzaSite Plus will be indicated for ophthalmic conditions, such as blepharitis, in which simultaneous antimicrobial and anti-inflammatory treatments are required. Both AzaSite and AzaSite Plus achieve high tissue levels of drug with reduced dosing frequency compared with currently available forms of treatment.

The Phase I clinical study was intended to evaluate both the safety and tolerability of the AzaSite Plus formulation in healthy volunteers. The trial enrolled 46 subjects of ages ranging from 19 to 67 years. Trial participants received eyedrops of either placebo or AzaSite Plus two times daily for 14 days. Demographic characteristics were evenly distributed across treatment groups.

Preliminary safety data showed that AzaSite Plus was well tolerated. No serious adverse events were reported. Treatment-related ocular adverse events were minimal in frequency and equivalent between the two groups. There were no significant differences in intraocular pressure between the AzaSite Plus group and the placebo group after 14 days of treatment.