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InSite Vision completes patient enrollment for phase 1/2 clinical trial of anti-inflammatory compound

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ALAMEDA, Calif. — InSite Vision has completed patient enrollment for a phase 1/2 clinical trial of a topical anti-inflammatory agent for reducing the pain and inflammation linked with ocular surgery, the company announced in a news release.

ISV-303 combines a low concentration of bromfenac with the company's proprietary DuraSite drug delivery system.

The randomized, placebo-controlled trial, launched in August, includes 160 patients undergoing cataract surgery. Patients were randomized to receive bromfenac once or twice daily, ISV-303, or DuraSite vehicle, according to the release.

Patient dosing and follow-up are scheduled to be conducted this month. Preliminary data are expected to be announced in the first half of 2011.

"We are very pleased by our team's performance on the accelerated rate of enrollment of this phase 1/2 clinical trial, which was one of the fastest rates on record for a trial of this size and design," Timothy Ruane, chief executive officer of InSite Vision, said in the release. "With an improved efficacy and safety profile, and patent protection extending into 2029, we believe ISV-303 is well positioned to compete in the expanding $300 million ophthalmic NSAID U.S. market."

ISV-303 showed promising results in a preclinical, head-to-head comparison with topical bromfenac, the release said. Results are scheduled to be published in the first quarter of 2011.

In combination with a low concentration of bromfenac and DuraSite, InSite Vision's bioadhesive polymer technology, ISV-303 is designed to enhance penetration by providing drug resistance on the ocular surface. It is hoped that the drug's durability and penetration will prevent cystoid macular edema and other postoperative complications.