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Novagali Pharma Announces FDA of an IND for Phase III Catioprost

Novagali Pharma has announced that the Food and Drug Administration U.S. (FDA) has approved the application of new experimental drug (IND) of the Company for a Phase III clinical trial of Catioprost (R) (Nova21027) for the treatment of glaucoma. Catioprost (R) is a topical ocular formulation of latanoprost to BAK-free patented, which benefits from the protective properties of the ocular surface of Novasorb (R), its patented technology based cationic emulsion.

The properties of Novasorb (R) have been clinically validated through Cationorm (R), a product marketed for relieving symptoms of dry eyes and Cyclokat (R), a product in Phase III for the treatment of dry eye moderate and severe.

The FDA agreed that Novagali appropriate to the clinical trial phase III pivotal in United States with Catioprost (R) in patients with glaucoma in order to assess the safety and efficacy of the product.

"With this fourth product entering clinical development Novagali its full product line of late stage," dijoJerome Martinez, director general and CEO of Novagali Pharma. "We hope Catioprost (R) will make a significant improvement in safety and comfort for patients with glaucoma, particularly those suffering from diseases in the ocular surface."


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