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InSite finishes enrollment for AzaSite phase 3 study

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ALAMEDA, Calif. — Enrollment in a phase 3 trial for AzaSite for the treatment of bacterial conjunctivitis has been completed, according to a press release from the drug’s developer.

InSite Vision said one of its two planned phase 3 trials for the drug will be a randomized, double-blind, active-controlled study to evaluate the safety and efficacy of AzaSite, a 1% azithromycin drug delivered through the company’s drug-delivery vehicle, DuraSite. Patients in the phase 3 trial were treated for 5 days with either AzaSite or tobramycin ophthalmic solution, the release stated.

Initial results from the study indicated the drug was well tolerated by patients with no drug-related adverse events. A total of 69 sites were involved in the study, with 58 sites in the United States and 11 in three Latin American countries, InSite said in the release.

If approved, InSite said AzaSite “will become the first ocular antibiotic with a once daily dosing regimen after an initial loading dose, which may increase patient compliance and therapeutic efficacy.”