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Novagali Pharma phase 1 trial for DME treatment under way

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EVRY, France — Novagali Pharma has initiated a phase 1 clinical trial evaluating the safety and efficacy of its Cortiject ophthalmic emulsion for treating diabetic macular edema, the company announced in a press release.

Cortiject is based on the company's Eyeject technology platform, which allows for the sustained release of a corticosteroid prodrug to the posterior segment of the eye, the release said.

The open-label, dose-escalation trial will enroll a total of 15 patients with DME in three treatment groups, with patients receiving one of three doses of Cortiject over 1 year of follow-up. Each injection will provide the patient with sustained exposure to the compound for about 9 months, the release said.

Novagali Pharma's investigational new drug application to conduct the study was granted by the U.S. Food and Drug Administration in January, according to the release.