Navigation Links
Novagali Pharma Announces FDA Clearance of IND for Phase III of Catioprost(R), its Cationic Emulsion of Latanoprost in Patients With Glaucoma

EVRY, France, May 5 /PRNewswire/ -- Novagali Pharma, a French pharmaceutical ophthalmic company, announces today 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."

About Novagali Pharma :

Novagali Pharma is an ophthalmic pharmaceutical company that develops and commercializes innovative products. Thanks to its proprietary technology platforms Novasorb(R) and Eyeject(R), the company has developed innovative products addressing main ocular conditions as well as orphan diseases. Most advanced products include Vekacia(R), for treatment of vernal keratoconjunctivitis, Cyclokat(R), for the treatment of moderate-to-severe dry eye syndrome and Cortiject(R) for the treatment of diabetic retinopathies. Cationorm(R), indicated for dry eye symptoms is commercialized in France since April 2008. Founded in 2000, Novagali Pharma is based in the Genopole biocluster in Evry (France).

In 2009, Frost & Sullivan recognized Novagali with the North American Award for Industry Innovation & Advancement of the Year, for its two proprietary emulsion technology platforms, Novasorb(R) and Eyeject(R).

SOURCE Novagali Pharma
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Frost & Sullivan Recognizes Novagali Pharma for Innovation in Ophthalmic Therapies
2. Novagali Pharma Completes a EUR15 Million Fund Raising
3. Novagali Pharma Announces the Launch of Cationorm(R)
4. Fifth Annual SemTech Conference Highlights How Semantics Power Chemistry, Pharmaceutical, Healthcare, and Other Life Science Solutions
5. Amylin Pharmaceuticals Announces a New Sales Approach to Better Target the Diabetes Market
6. Circ Pharma Limited Enters Into Development Agreement for Chrono Tramadol With Elan Corporation Plc
7. The Global Active Pharmaceutical Ingredients (API) Market: A Frost & Sullivan Briefing on Changing Dynamics
8. First Patient Dosed in Phase I Clinical Trial of Tigris Pharmaceuticals GGTI-2418
9. BioMed Realty Trust Expands Landmark Leases With Regeneron Pharmaceuticals
10. WuXi PharmaTech Schedules First-Quarter 2009 Earnings Release
11. Idenix Pharmaceuticals Reports First Quarter Financial Results
Post Your Comments:
(Date:6/24/2016)... TOKYO , June 24, 2016  Regular discussions on ... to take place between the two entities said Poloz. ... in Ottawa , he pointed to the ... and the federal government. ... Poloz said, "Both institutions have common economic goals, why not ...
(Date:6/24/2016)... ... June 24, 2016 , ... While the majority of commercial spectrophotometers and ... and the 6000i models are higher end machines that use the more unconventional z-dimension ... light beam from the bottom of the cuvette holder. , FireflySci has developed ...
(Date:6/23/2016)... WA (PRWEB) , ... June 23, 2016 , ... ... announces the release of its second eBook, “Clinical Trials Patient Recruitment and Retention ... recruitment and retention in this eBook by providing practical tips, tools, and strategies ...
(Date:6/23/2016)... , June 23, 2016   Boston ... of novel compounds designed to target cancer stemness ... has been granted Orphan Drug Designation from the ... treatment of gastric cancer, including gastroesophageal junction (GEJ) ... inhibitor designed to inhibit cancer stemness pathways by ...
Breaking Biology Technology:
(Date:6/16/2016)... June 16, 2016 The ... expected to reach USD 1.83 billion by 2024, ... Research, Inc. Technological proliferation and increasing demand in ... expected to drive the market growth. ... The development of advanced multimodal techniques for ...
(Date:6/3/2016)... , June 3, 2016 ... von Nepal hat ... Lieferung hochsicherer geprägter Kennzeichen, einschließlich Personalisierung, Registrierung ... in der Produktion und Implementierung von Identitätsmanagementlösungen. ... Ausschreibung im Januar teilgenommen, aber Decatur wurde ...
(Date:5/24/2016)... Ampronix facilitates superior patient care by providing unparalleled technology to leaders of ... the latest premium product recently added to the range of products distributed by Ampronix. ... ... ... Medical Display- Ampronix News ...
Breaking Biology News(10 mins):