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Novagali Pharma’s IND for glaucoma drug wins FDA clearance

Novagali Pharma, an ophthalmic pharmaceutical company, has received the FDA clearance for its investigational new drug application to conduct a Phase III clinical trial of Catioprost for the treatment of glaucoma.

According to Novagali Pharma, Catioprost is a topical ocular proprietary BAK-free formulation of latanoprost which furthermore 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.

The FDA agreed that Novagali may proceed with a pivotal Phase III clinical trial in the US with Catioprost in patients with glaucoma aiming to evaluate the safety and the efficacy of the product.

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