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:2/12/2016)... ... ... Global Stem Cells Group has announced an inaugural conference and stem cell ... 24-March 6, 2016. The new facility will provide advanced protocols and state-of-the-art techniques in ... CEO Benito Novas will host the event, which will begin with a stem cell ...
(Date:2/12/2016)... FRANCISCO , February 12, 2016 ... Medicine Efforts by Enabling Scientific Understanding of Complex ... and Rare Diseases --> ... genomic diagnostics in South Asia and a leading provider ... would contribute $10 million to the GenomeAsia 100K ...
(Date:2/11/2016)... NEW YORK , Feb. 11, 2016  Bioethics International, ... how medicines are researched, developed, marketed and made accessible to ... BMJ Open had named the publication of the ... for 2015. The publication is also featured as one of ... published in the last year that are most frequently read. ...
(Date:2/11/2016)... February 11, 2016 ... or "Company") (OTCQB: PSID), a life sciences company ... its Thermomedics subsidiary, which markets the Caregiver® FDA-cleared ... plan in January 2016, including entering into agreements ... monthly sales growth, and establishing several near-term pipeline ...
Breaking Biology Technology:
(Date:1/22/2016)... DUBLIN , Jan. 22, 2016 /PRNewswire/ ... announced the addition of the "Global ... report to their offering. --> ... of the "Global Biometrics Market in ... offering. --> Research and ...
(Date:1/20/2016)... 2016 A market that just keeps on ... the explosion in genomics knowledge. Learn all about it ... range of dynamic trends are pushing market growth and ... - pharmacogenomics - pathogen evolution - next generation sequencing ... greater understanding of the role of genetic material in ...
(Date:1/20/2016)... 2016  Synaptics Incorporated (NASDAQ: SYNA ), ... announced sampling of S1423, its newest ClearPad ® ... screen applications including smartwatches, fitness trackers, and touch ... rectangular shapes, as well as thick and curved ... on screen, while wearing gloves, and supports swipes ...
Breaking Biology News(10 mins):