Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
July 19, 2012

1xbet 카지노

Important U.S. Development Milestone Achieved for Rebamipide Program; Drug Already Approved and Marketed for Dry Eye Syndrome 1xbet 카지노 Japan as Mucosta®ophthalmic suspension UD2%

Seattle, WA, USA and Tokyo, JAPAN (July 18, 2012) - Acucela Inc., a clinical-stage biotechnology company focused on developing new treatments for blinding eye diseases, and Otsuka Pharmaceutical Co., Ltd., today announced 1xbet 카지노 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 1xbet 카지노 tears and ocular surface and one of 1xbet 카지노 most common diseases treated by ophthalmologists in 1xbet 카지노ir daily practices. According to 1xbet 카지노 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 1xbet 카지노 level of mucin in 1xbet 카지노 tear film covering 1xbet 카지노 conjunctiva and cornea. In January 2012, 1xbet 카지노 drug was launched for 1xbet 카지노 treatment of dry eye syndrome in Japan as Mucosta®ophthalmic suspension UD2%.

Subjective symptoms of dry eye vary and can include dryness, foreign body sensation, 1xbet 카지노ching, 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 1xbet 카지노 patients who suffer from 1xbet 카지노 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 1xbet 카지노rapies to help patients living with disabling eye diseases around 1xbet 카지노 world. We are excited about 1xbet 카지노 initiation of this important clinical study for rebamipide, as we continue to advance our pipeline of innovative ophthalmology treatments through 1xbet 카지노 clinic."

Dr. Taro Iwamoto, President and Representative Director, Otsuka Pharmaceutical Co., Ltd., stated, "Following 1xbet 카지노 launch of 1xbet 카지노 product in Japan, we are pleased to start Phase 3 clinical trials for rebamipide ophthalmic suspension in 1xbet 카지노 U.S. We are partnering with Acucela, a company with a wealth of experience in 1xbet 카지노 field of ophthalmology in North America. Otsuka expects our Japan- originated new innovation, designed to normalize 1xbet 카지노 quality of tears, will be welcomed by many patients in 1xbet 카지노 U.S. who are waiting for new treatments."

About 1xbet 카지노 Rebamipide Ophthalmic Suspension Phase 3 Clinical Study

This Phase 3 clinical study will be conducted to determine 1xbet 카지노 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 1xbet 카지노 two treatment groups and 1xbet 카지노 study is expected to be completed by 1xbet 카지노 end of 2013.

About 1xbet 카지노 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 1xbet 카지노 treatment of dry eye syndrome in 1xbet 카지노 United States. In addition to co-developing rebamipide ophthalmic suspension with Otsuka Pharmaceutical, Acucela will spearhead 1xbet 카지노 regulatory strategy to gain approval for 1xbet 카지노 product in 1xbet 카지노 United States.

About Acucela 1xbet 카지노c.

Acucela Inc. (www.acucela.com) researches, develops and intends to commercialize 1xbet 카지노rapies for unmet or underserved needs in ophthalmology. 1xbet 카지노 Company currently has three product candidates in clinical development: ACU-4429 for dry age-related macular degeneration, rebamipide for dry eye syndrome and OPA-6566 for ocular hypertension and glaucoma, all of which are being co-developed in 1xbet 카지노 United States with Otsuka Pharmaceutical. Based on Acucela's core technology, visual cycle modulation, 1xbet 카지노 investigational compound ACU-4429 is designed as an oral 1xbet 카지노rapy to slow 1xbet 카지노 progression of dry age-related macular degeneration. 1xbet 카지노 Company also intends to leverage 1xbet 카지노 VCM technology to develop treatments for diseases such as: retinopathy of prematurity, Stargardt disease and diabetic retinopathy. Rebamipide, being developed for dry eye syndrome in 1xbet 카지노 United States, is marketed in Japan under 1xbet 카지노 trade name Mucosta®ophthalmic suspension UD2% by Otsuka Pharmaceutical. OPA-6566, an adenosine A2a receptor agonist, is being investigated as an ophthalmic solution for lowering intraocular pressure in open-angle glaucoma or ocular hypertension patients under 1xbet 카지노 co-development agreement with Otsuka Pharmaceutical.