Phase I trial of Novagali's investigational DME injection begins

April 30, 2008

Cortiject, Novagali Pharma's investigational treatment for Diabetic Macular Oedema (DME), has successfully been injected into the first patient in its Phase I clinical trial.

Cortiject, Novagali Pharma's investigational treatment for Diabetic Macular Oedema (DME), has successfully been injected into the first patient in its Phase I clinical trial. Cortiject is an injectable emulsion containing a corticosteroid; the open-label, dose-escalation trial, evaluating safety and efficacy, will enrol 15 patients.

Patients in the study will be segmented into three arms, each being treated with different doses of a single intravitreal Cortiject injection. The prodrug will remain in the patient's system for nine months, and follow-up will be for 12 months.

Novagali Pharma received the FDA Investigational New Drug Application (IND) for this trial in January 2008.