Novagali Pharma Announces FDA Clearance Of IND For Phase III Of Catioprost(R), Its Cationic Emulsion Of Latanoprost In Patients With Glaucoma

Main Category: Eye Health / Blindness
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials
Article Date: 07 May 2009 - 3:00 PDT

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Novagali Pharma, a French pharmaceutical ophthalmic company, announces that the Company's Investigational New Drug Application (IND) to conduct a Phase III clinical trial of Catioprost(R) (Nova21027), for the treatment of glaucoma has been granted by the U.S. Food and Drug Administration (FDA). Catioprost(R) is a topical ocular proprietary BAK-free formulation of latanoprost which furthermore benefits from the ocular surface protection properties of Novasorb(R), its patented technology based on cationic emulsion.

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

Glaucoma is a group of diseases that can damage the eye's optic nerve and result in vision loss and blindness. It is estimated that more than 65 million people worldwide suffer from glaucoma, 4 million of whom in the US.

For these patients treated on a long term basis, toxicity of preservatives is a major concern. In fact the prevalence of ocular surface disease in glaucoma patients is estimated to be ranging from 30 to 70% depending on definition and severity. Coexistence of glaucoma and ocular surface disorder may impact vision related quality of life.

Catioprost(R) is a topical ocular BAK-free emulsion of latanoprost that present a safer profile than BAK-containing marketed products for glaucoma. This is a major advantage since it is admitted that BAK exerts toxicity after long term use and that glaucoma is a chronic disease needing life-long daily treatment. Furthermore, the stability product profile allows storage at room temperature.

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

"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(R) to bring significant safety and comfort improvement for glaucoma patients, especially for those suffering from ocular surface diseases."

Source
Novagali Pharma

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