Dry-eye agent starts phase III trial

Seattle and Tokyo-Acucela Inc. and Otsuka Pharmaceutical Co. Ltd. have announced the initiation of a phase III clinical trial to evaluate rebamipide ophthalmic suspension in patients with dry eye syndrome.

The phase III study will be conducted to determine the efficacy and safety of 2% rebamipide ophthalmic suspension in subjects with dry eye syndrome. It is a multi-center, randomized, placebo-controlled, double-masked, parallel-group study that will enroll approximately 560 subjects equally into the two treatment groups. It is expected to be completed by the end of 2013.

Rebamipide ophthalmic suspension increases the level of mucin in the tear film covering the conjunctiva and cornea. The drug was launched in Japan in January for the treatment of dry eye syndrome (Mucosta ophthalmic suspension UD2%).

“Advancing rebamipide ophthalmic suspension into late-stage development is an exciting and important milestone for Acucela and for the patients who suffer from the debilitating effects of dry eye,” said Ryo Kubota, MD, PhD, chairman, president, and chief executive officer, Acucela Inc.

Otsuka Pharmaceutical and Acucela entered into an agreement in September 2008 to co-develop rebamipide ophthalmic suspension for the treatment of dry eye syndrome in the United States. In addition to co-developing rebamipide ophthalmic suspension with Otsuka Pharmaceutical, Acucela will spearhead the regulatory strategy to gain approval for the product in the United States.

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