Navigation Links
Novagali Pharma Announces FDA Clearance of IND for Phase III of Catioprost(R), its Cationic Emulsion of Latanoprost in Patients With Glaucoma
Date:5/5/2009

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 : http://www.novagali.com

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:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... A person commits a crime, and the detective ... the criminal down. An outbreak of foodborne illness ... (FDA) uses DNA evidence to track down the bacteria that ... It,s not. The FDA has increasingly used a complex, cutting-edge ... illnesses. Put as simply as possible, whole genome sequencing is ...
(Date:6/23/2016)... , June, 23, 2016  The Biodesign Challenge (BDC), ... new ways to harness living systems and biotechnology, announced ... (MoMA) in New York City . ... participating students, showcased projects at MoMA,s Celeste Bartos Theater ... Antonelli , MoMA,s senior curator of architecture and design, ...
(Date:6/23/2016)... ... June 23, 2016 , ... In a new case report published today in ... patient who developed lymphedema after being treated for breast cancer benefitted from an injection ... for dealing with this debilitating, frequent side effect of cancer treatment. , ...
(Date:6/23/2016)... YORK , June 23, 2016 ... trading session at 4,833.32, down 0.22%; the Dow Jones Industrial ... S&P 500 closed at 2,085.45, down 0.17%. Stock-Callers.com has initiated ... INFI ), Nektar Therapeutics (NASDAQ: NKTR ), ... Therapeutics Inc. (NASDAQ: BIND ). Learn more about ...
Breaking Biology Technology:
(Date:5/24/2016)... Ampronix facilitates superior patient care by providing unparalleled technology to leaders of the medical ... premium product recently added to the range of products distributed by Ampronix. ... ... ... Ampronix News ...
(Date:5/12/2016)... May 12, 2016 WearablesResearch.com , a ... the overview results from the Q1 wave of its ... wave was consumers, receptivity to a program where they ... a health insurance company. "We were surprised ... says Michael LaColla , CEO of Troubadour Research, ...
(Date:4/28/2016)... India , April 28, 2016 ... Infosys (NYSE: INFY ), and Samsung SDS, a ... that will provide end customers with a more secure, ... services.      (Logo: http://photos.prnewswire.com/prnh/20130122/589162 ) , ... services, but it also plays a fundamental part in enabling ...
Breaking Biology News(10 mins):