Novagali's IND application for DME treatment granted

Novagali Pharma's Investigational New Drug Application (IND) to conduct Phase I clinical trials of its Nova63035, for the treatment of diabetic macular oedema (DME), has been granted by the FDA.

Nova63035 is a unique injectable emulsion that allows sustained release of the prodrug over a six to nine month period. The prodrug is converted into the drug by the presence of enzymes, which are present in the retina and choroids. This specific distribution of the enzymes could allow for avoidance of the common corticosteroid side effects, such as an increase of intraocular pressure and opacification of the lens.

The Phase I trials will be conducted in the US and will evaluate safety and efficacy over a twelve-month period.