This trial, which will enroll a total of 15 patients, is designed to evaluate the safety and to observe the efficacy trend of Cortiject. The patients will be monitored for a period of 12 months following injection.
Investigators for this open-label, dose-escalation study will treat patients suffering from diabetic macular edema with a single intravitreal injection (inside the eye) of Cortiject formulation. The trial will include three treatment arms with patients receiving one of three doses of Novagali corticosteroid prodrug. Each administration of Cortiject will provide the patient with exposure to the compound for approximately nine months.
Jerome Martinez, CEO of Novagali Pharma, said: “Thanks to Eyeject technology, Cortiject is a major move with the optimized use of corticosteroids for the back of the eye expected to combine ease of use, sustained release and ocular safety.”