Navigation Links
Novagali Pharma Announces Positive Vekacia Clinical Results From,Pivotal Phase III Trial in Vernal Keratoconjunctivitis

EVRY, France, April 04, 2007 /PRNewswire/ -- Novagali Pharma, an emerging ophthalmic pharmaceutical company specialized in ophthalmology, announces today positive results from the Phase III clinical study of Vekacia(R) in children suffering from Vernal Keratoconjunctivitis (VKC). In this orphan disease, it was shown that both symptoms and signs of disease improved in patients receiving Vekacia(R). Furthermore, the tolerability to Vekacia(R) was excellent.

VKC is a severe form of chronic allergic conjunctivitis characterized by ocular discomfort, pain, itching and intense photophobia, which severely debilitates the patients. This rare disease affects mostly children and young adults living in warm climates worldwide. In March 2006, Novagali received European Medicines Agency (EMEA) orphan drug designation for Vekacia(R) in the treatment of VKC.

The study was conducted by key experts and opinion leaders in the field of ocular allergy throughout Europe and Mediterranean area and lead by Pr David Ben Ezra, Hadassah Hebrew University Hospital, Jerusalem, who first reported on the use and potential efficacy of Cyclosporine A for the treatment of VKC.

Vekacia(R) is a topical Cyclosporine A cationic emulsion enabling an efficient and unmatched-level drug absorption in tissues of the eye leading to optimal therapeutic efficacy. This proprietary ophthalmic emulsion of Cyclosporine A will be the first therapeutic product dedicated to treatment of such a severe ocular condition.

"We achieved a major corporate milestone completing our first phase III clinical trial" declares Jerome Martinez, President & CEO of Novagali, "I am very enthusiastic about the confirmation of the high potential of Novasorb(R) cationic emulsion technology through the development of Vekacia(R) and its successful use in VKC. It is very encouraging for the other ongoing projects".

"It is a great satisfaction to b e able to anticipate providing a product addressing such an unmet therapeutic need in a paediatric population" says Florence Binlich Novagali's Medical Director who adds "we are also impressed by the high level of motivation and enthusiasm of the experts who participated in the trial".

"As practicing clinicians, we are very pleased to observe that Vekacia(R) brought significant benefits even in severe forms of the disease" declared Pr Ben Ezra, study lead investigator "It can confidently be said that now, the treating ophthalmologists may have, finally, a new and efficient tool for the management of VKC".

Based upon the results of the study, Novagali plans to file European Marketing Authorization mid-2007.

About Novagali Pharma: http://www.novagali.com

Novagali Pharma SA is an emerging ophthalmic pharmaceutical company based in the Genopole biocluster in Evry, France, that develops innovative products for all segments of the eye. Thanks to its proprietary technology platforms Novasorb(R) and Eyeject(R), the company has developed a broad pipeline of 6 innovative products addressing main ocular conditions as well as orphan diseases. Most advanced products include Vekacia(R), an orphan product for treatment of vernal keratoconjunctivitis; Cationorm(R), a CE marking product for dry eye relief; and Nova22007, a product for the treatment of moderate-to-severe dry eye syndrome. Founded in 2000, the firm has raised a total amount of Euro 44 million in 3 series of financing.

CONTACT: Press Contact: Genevieve Garrigos, +33(0)6-82-85-58-99, genevieve.garrigos@novagali.com

Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company


'"/>




Related medicine technology :

1. Novagali Pharma Presents at AACO the Results of its Pivotal Phase III Clinical Trial of Vekacia in Children Suffering From Vernal Keratoconjunctivitis
2. Sygnis Pharma AG announces date for presentation of clinical results
3. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
4. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
5. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
6. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
7. Auxilium Pharmaceuticals to Present at the 2007 CEUT Emerging Growth Opportunities Conference
8. Sunesis Pharmaceuticals to Present at the C. E. Unterberg, Towbin Emerging Growth Conference
9. EPIX Pharmaceuticals to Present at the C.E. Unterberg, Towbin Emerging Growth Opportunities Conference
10. Array BioPharma to Present at the C.E Unterbeg, Towbin Emerging Growth Conference
11. AM-Pharma Announces Positive Results of Phase IIa Clinical Trial with Alkaline Phosphatase For Ulcerative Colitis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/19/2017)... NEW YORK , Jan. 19, 2017 ... ... Forecast 2016-2026: Opportunities for Leading Companies – our new ... new report discusses issues and events affecting the Alzheimer,s ... qualitative analyses to answer these key questions: - How ...
(Date:1/19/2017)... , Jan. 19, 2017  Stealth BioTherapeutics Inc. ... to treat mitochondrial dysfunction, today announced new additions to ... M.D., as Chief Medical Officer, and Daniel Geffken ... announced that Jim Carr , Pharm.D. has been ... "We are pleased to welcome Doug and Daniel to ...
(Date:1/19/2017)... -- Accuray Incorporated (Nasdaq: ARAY ) announced ... set the bar for excellence in customer satisfaction. The ... rating among radiation treatment delivery systems in the U.S., ... Briefing™. The most recent ratings trend also shows Accuray ... for 11 of the past 12 quarters. ...
Breaking Medicine Technology:
(Date:1/20/2017)... ... January 20, 2017 , ... Vitamin Well has launched ... The drinks have been produced in collaboration with Zlatan Ibrahimovic and have been ... , After a successful launch in Sweden last year, the next generation sports ...
(Date:1/20/2017)... ... January 20, 2017 , ... “The Angel”: a ... has set out for each of his children. “The Angel” is the creation of ... Music in New York City, and impassioned writer. , When asked of her new ...
(Date:1/20/2017)... ... , ... “I Forgive You”: a fine examination of how God handles sin, including how ... published author, Stephen Miller, who, for over ten long years has been waiting to release ... Trinidad and Tobago, he has been serving the Lord for over twenty years, and he ...
(Date:1/20/2017)... , ... January 20, 2017 , ... “Christmas in Suffolk”: ... of published author, Sara Seymour, who lives in Lafayette, Indiana where she works in ... on iced coffees and writes. , Published by Christian Faith Publishing, Sara Seymour’s new ...
(Date:1/20/2017)... ... 2017 , ... “Knowledge is God’s Lighthouse”: a moving and colorful collection ... is the creation of published author, Gene Gaapf, a retired truck driver, and a ... have been writing since high school and have many different titles,” Gaapf mentions about ...
Breaking Medicine News(10 mins):