Catioprost gets the go-ahead for Phase III trial

May 13, 2009

Novagali Pharma, the French pharmaceutical ophthalmic company, is to conduct a Phase III clinical trial of Catioprost (Nova21027) its Investigational New Drug Application (IND).

Novagali Pharma, the French pharmaceutical ophthalmic company, is to conduct a Phase III clinical trial of Catioprost (Nova21027) its Investigational New Drug Application (IND). The US FDA has agreed that Novagali may proceed with a pivotal Phase III clinical trial in the United States with Catioprost in patients with glaucoma aiming to evaluate the safety and the efficacy of the product.

Designed for the treatment of glaucoma Catioprost is a topical ocular proprietary BAK-free formulation of latanoprost that benefits from the ocular surface protection properties of Novasorb, its patented technology based on cationic emulsion.

Novasorb properties have already been clinically validated through Cationorm a marketed product for dry eye symptoms relief and Cyclokat, a pharmaceutical product in phase III for the treatment of moderate to severe dry eye.

"With this fourth pharmaceutical product entering in clinical development, Novagali completes its late stage product pipeline" said Jerome Martinez, president and CEO of Novagali Pharma. "We expect Catioprost to bring significant safety and comfort improvement for glaucoma patients, especially for those suffering from ocular surface diseases."