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Novagali Pharma Completed a New Phase II With Cyclokat(R) in Dry Eye


4/15/2009 10:22:17 AM

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.

CONTACT: Contact: Genevieve Garrigos, VP RH & Communication,
+33-6-65-54-60-19



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