Navigation Links
Novagali Pharma Completed a New Phase II With Cyclokat(R) in Dry Eye
Date:4/15/2009

EVRY, France, April 15 /PRNewswire/ -- Novagali Pharma, a French pharmaceutical ophthalmic company, today announces successful completion of a new Phase II clinical study with Cyclokat(R), its formulation of Cyclosporine. The results demonstrate statistically significant improvement with signs and symptoms in patients suffering from moderate-to-severe dry eye syndrome.

For this dry eye clinical trial, Novagali worked with Ora, Inc., a leading global clinical research and development organization located in Andover, MA, USA. This phase II, multi-centre, randomized, double-masked, vehicle controlled study of 132 patients evaluated the safety and efficacy of Cyclokat(R) applied once-a-day over three months. Ora's proprietary Controlled Adverse Environment (CAE) clinical model was used in this study conducted in the US.

Efficacy was observed post-CAE as well as pre-CAE (environmental comparisons following selection and enrollment of patients utilizing the CAE). Cyclokat(R) demonstrated significant treatment effect on multiple efficacy variables for both signs and symptoms at Month 1 and Month 3. . These findings confirm potential clinical interest of Cyclokat(R) for the treatment of dry eye syndrome.

"We are very enthusiastic about the results of this new trial demonstrating efficacy on both dry eye signs and symptoms" said Jerome Martinez, CEO of Novagali "These are promising results which make us confident in the success of our ongoing Phase III which outcomes are expected 4Q2009".

A pivotal Phase III trial is ongoing in Europe and patient recruitment has been already completed.

Cyclokat(R) is a proprietary ophthalmic emulsion enabling an optimal penetration of Cyclosporine in tissues of the eye surface that benefit from Novasorb(R), Novagali(R) cationic emulsion technology.

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).

About Ora, Inc.

Ora is the leading independent ophthalmic drug and device development firm, with more than 27 NDA approvals for its clients during its 30-year history. Ora provides technology-based, concept-to-market services and solutions that accelerate development timelines while maintaining the highest standards for clinical research.


'/>"/>
SOURCE Novagali Pharma
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Novagali Pharma Presents Results of its Innovative Latanoprost Formulation for Glaucoma
2. Novagali Pharma Successfully Enrolls First Patient in U.S. Phase I Clinical Study with CORTIJECT(R) for Diabetic Macular Edema
3. Osprey Pharmaceuticals U.S.A., Inc. Initiates Phase Ib Clinical Trial in IgA Nephropathy
4. Pharmacyclics Initiates Phase 1 Clinical Trial of Novel Oral Btk Inhibitor for Refractory B-cell Non-Hodgkins Lymphoma
5. Optimer Pharmaceuticals Receives Production Patent for Lead Product Candidate Fidaxomicin
6. Raptor Pharmaceuticals Appoints Dr. Patrice P. Rioux as Chief Medical Officer
7. Strativa Pharmaceuticals Provides Product Pipeline Update
8. Rib-X Pharmaceuticals Novel Antibiotic Delafloxacin Named One of R&D Directions 100 Great Investigational Drugs of 2009
9. Pharmaxis Announces Milestone in Phase III Trial for Cystic Fibrosis
10. Pharmasset Initiates First Time in Human Study of PSI-7851 for the Treatment of Hepatitis C (HCV)
11. Arena Pharmaceuticals to Host Conference Call and Webcast on Monday, March 30, 2009 to Discuss Lorcaserin Pivotal Phase 3 Obesity Trial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... DUBLIN , June 23, 2016 ... "Dialysis Devices Global Market - Forecast to 2022" report ... is the treatment method for the patients with kidney failure, ... and excess fluid from the patient,s blood and thus the ... sodium, potassium and chloride in balance. Increasing ...
(Date:6/23/2016)... Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that it ... (procalcitonin) assay as a dedicated testing solution for people ... Roche is the first IVD company in the U.S ... assessment and management. PCT is a sepsis-specific ... blood can aid clinicians in assessing the risk of ...
(Date:6/23/2016)... Bracket , a leading clinical trial technology ... outcomes platform, Bracket eCOA (SM) 6.0, at the 52 ... 30, 2016 in Philadelphia , Pennsylvania.  A ... product of its kind to fully integrate with RTSM, will ... 6.0 is a flexible platform for electronic clinical outcomes assessments ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... ... of Bruton Memorial Library on June 21 due to a possible lice infestation, as reported ... head lice: the parasite’s ability to live away from a human host, and to infest ... in the event that lice have simply gotten out of control. , As lice are ...
(Date:6/25/2016)... ... 25, 2016 , ... First Choice Emergency Room , the largest network ... the Medical Director of its new Mesquite-Samuell Farm facility. , “We are pleased ... location,” said Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin Johnson ... Recently, he has implemented orthobiologic procedures as a method for treating his patients. ... the first doctors to perform the treatment. Orthobiologics are substances that orthopaedic surgeons ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits of moderation, ... the latter, setting the bar too high can result in disappointment, perhaps even self-loathing. ... toward their goal. , Research from PsychTests.com reveals that behind the ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Those who have ... these feelings, many turn to unhealthy avenues, such as drug or alcohol abuse, as ... Michigan, has released tools for healthy coping following a traumatic event. , Trauma sufferers ...
Breaking Medicine News(10 mins):