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Novagali Pharma receives FDA clearance for a phase 1 trial of a potential DME treatment
EVRY, France — Novagali Pharma has been granted an investigational new drug application by the U.S. Food and Drug Administration, allowing the company to initiate a phase 1 clinical trial of Nova63035, the company announced in a press release. The ophthalmic injectable emulsion is based on Novagali's Eyeject corticosteroid prodrug technology and would treat diabetic macular edema.
Eyeject technology allows for the sustained release of a corticosteroid prodrug over 6 to 9 months that is converted into Nova63035 by enzymes in the retina and choroid. These enzymes are not present in the vitreous or in the aqueous humor, the release said.
This specific enzyme circulation could prevent common corticosteroid side effects, including elevated IOP and lens opacification, the release said.
The study will evaluate the safety and efficacy of Nova63035 over 12 months follow-up.