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news.Novagali Pharma has received FDA clearance for the company's investigational new drug application to conduct a Phase I clinical trial of Nova63035, an ophthalmic injectable emulsion based on Eyeject technology containing a corticosteroid prodrug, for the treatment of diabetic macular edema.
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The FDA has agreed that Novagali may proceed with Phase I clinical trials in the US in patients with diabetic macular edema (DME) aiming to evaluate the safety and to observe the efficacy trend of the injection of Nova63035. The patients will be monitored for a period of twelve months following injection.
Jerome Martinez, president and CEO of Novagali Pharma, said: “This step is very encouraging for the research teams that have developed this first product candidate based on our innovative proprietary Eyeject technology designed to allow the administration of drugs to the back of the eye.”