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Phase 3 Trial Evaluates Rebamipide Ophthalmic Suspension in Patients With Dry Eye Syndrome
Dry eye is one of the most common disorders treated by ophthalmologists in their daily practices. An estimated 25 million Americans and 370 million people worldwide have the disorder.
Rebamipide ophthalmic suspension increases the level of mucin in the tear film covering the conjunctiva and cornea. In January 2012, the drug was launched for the treatment of dry eye syndrome in Japan as Mucosta ophthalmic suspension UD2%.
The new phase III study will evaluate the efficacy and safety of 2% rebamipide ophthalmic suspension in approximately 560 subjects with dry eye syndrome. The trial is expected to be completed by the end of 2013. Acucela and Otsuka entered into an agreement on September 4, 2008 to co-develop rebamipide ophthalmic suspension for the treatment of dry eye syndrome in the U.S. Acucela will lead the regulatory strategy to gain approval for the product in this country.
Read the full article on the Reuters Web site.