-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.

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.