Rebamipide in Phase III clinical (again)

Pardon me for not getting excited yet (we've been here before with this drug... long time ago now) but Rebamipide is back in Phase III clinicals. At this point though - rather like Diquafosol - it's already approved on being marketed in Japan. It will be interesting to see whether it makes it through the FDA this time around.

Acucela and Otsuka Pharmaceutical Announce the Initiation of a Phase 3 Clinical Trial to Evaluate Rebamipide Ophthalmic Suspension in Patients with Dry Eye Syndrome

SEATTLE & TOKYO, Jul 19, 2012 (BUSINESS WIRE) -- --Drug Already Approved and Marketed for Dry Eye Syndrome in Japan as--Mucosta(R) Ophthalmic Suspension UD2% 

Acucela Inc., a clinical stage biotechnology company focused on developing new treatments for blinding eye diseases, and Otsuka Pharmaceutical Co., Ltd., today announced the initiation of a Phase 3 clinical trial to evaluate rebamipide ophthalmic suspension in patients with dry eye syndrome. Dry eye is a multifactorial disease of the tears and ocular surface, and one of the most common diseases treated by ophthalmologists in their daily practices. According to the 2011 Market Scope Dry Eye Report, 25 million Americans and 370 million patients worldwide suffer from dry eye. 

Rebamipide ophthalmic suspension is a novel compound discovered by Otsuka Pharmaceutical and has a new mechanism of action to increase 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(R) ophthalmic suspension UD2%.Subjective symptoms of dry eye vary and can include dryness, foreign body sensation, itching, burning sensation, eye pain and photophobia. Advanced dry eye syndrome may lead to serious complications and ocular surface damage that can result in decreased vision. 

"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. "Today's announcement is in line with our strategy to develop leading-edge therapies to help patients living with disabling eye diseases around the world. We are excited about the initiation of this important clinical study for rebamipide, as we continue to advance our pipeline of innovative ophthalmology treatments through the clinic." 

Dr. Taro Iwamoto, President and Representative Director, Otsuka Pharmaceutical Co., Ltd., stated, "Following the launch of the product in Japan, we are pleased to start Phase 3 clinical trials for rebamipide ophthalmic suspension in the U.S. We are partnering with Acucela, a company with a wealth of experience in the field of ophthalmology in North America. Otsuka expects our Japan- originated new innovation, designed to normalize the quality of tears, will be welcomed by many patients in the U.S. who are waiting for new treatments." 

About the Rebamipide Ophthalmic Suspension Phase 3 Clinical Study 

This Phase 3 clinical 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. Approximately 560 subjects are planned to be enrolled equally into the two treatment groups and the study is expected to be completed by the end of 2013. 

About the Otsuka Pharmaceutical/Acucela Rebamipide Ophthalmic Suspension Agreement 

Otsuka Pharmaceutical and Acucela entered into an agreement on September 4, 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.