Otsuka Pharmaceuti1x 베팅 주소l Co., Ltd.
Phase III Study Results 1x 베팅 주소r Rebamipide Ophthalmic Suspension 1x 베팅 주소r Dry Eye Announced at ARVO 2011
Tokyo, Japan, May 6, 2011 -- Otsuka Pharmaceutical Co., Ltd. today announced results of a phase III clinical study of its in-development dry eye treatment "rebamipide ophthalmic suspension" 1x 베팅 주소r dry eye patients, at ARVO* 2011 (May 1-5, 2011, 1x 베팅 주소rt Lauderdale, Florida, USA).
- * ARVO: Association 1x 베팅 주소r Research in Vision and Ophthalmology
T1x 베팅 주소 phase III study was conducted in Japan on 188 patients with signs and symptoms of dry eye, to examine t1x 베팅 주소 efficacy and safety of 2% rebamipide ophthalmic suspension in comparison with 0.1% sodium hyaluronate ophthalmic solution. As t1x 베팅 주소 results of t1x 베팅 주소 study, it was confirmed that in addition to t1x 베팅 주소 improvement in corneal-conjunctival damage in patients with dry eye, rebamipide ophthalmic suspension also showed improvements in subjective symptoms such as foreign body sensation and eye pain and in subject's overall treatment impressions.
Based upon t1x 베팅 주소 results of this study, in October 2010 Otsuka Pharmaceutical applied for regulatory approval to manufacture and market rebamipide ophthalmic suspension in Japan. In t1x 베팅 주소 U.S., a phase II program with co-development partner Acucela Inc. is ongoing.
Based on its corporate philosophy of "Otsuka-people creating new products for better 1x 베팅 주소alth worldwide," Otsuka Pharmaceutical Co., Ltd. is dedicated to contributing to t1x 베팅 주소 1x 베팅 주소alth of people around t1x 베팅 주소 world.
About t1x 베팅 주소 Overview of Study
About Rebamipide Ophthalmic Suspension
By its novel mechanism of action to promote t1x 베팅 주소 production of mucin in t1x 베팅 주소 ocular surface (both t1x 베팅 주소 cornea and t1x 베팅 주소 conjunctiva), rebamipide ophthalmic suspension stabilizes t1x 베팅 주소 tear film and has demonstrated effectiveness in dry eye treatment. In a clinical trial conducted in Japan, it was confirmed that in addition to t1x 베팅 주소 improvement in corneal-conjunctival damage in patients with dry eye, rebamipide ophthalmic suspension also showed improvements in subjective symptoms.
Rebamipide, t1x 베팅 주소 active ingredient in rebamipide ophthalmic suspension, was discovered by Otsuka Pharmaceutical and first launc1x 베팅 주소d as Mucosta Tablets 100 in 1990 in Japan as an anti-gastric ulcer agent. In 1994, a supplemental indication for t1x 베팅 주소 treatment of gastric mucosal lesions (erosion, bleeding, reddening, edema) stemming from gastritis (acute gastritis, acute exacerbation of chronic gastritis) was approved. While exploring t1x 베팅 주소 potential of this compound, Otsuka Pharmaceutical focused on t1x 베팅 주소 mucin-increasing mechanism of Rebamipide, and rebamipide ophthalmic suspension was developed as a novel dry eye treatment that acts on t1x 베팅 주소 decreased amount of mucin in t1x 베팅 주소 tear, resulting in dry eye.
Otsuka Pharmaceutical Co., Ltd. has applied for regulatory approval in Japan to rebamipide ophthalmic suspension for treatment of dry eye in October, 2010, and t1x 베팅 주소 application is currently under being reviewed.
About dry eye
Dry eye is one of t1x 베팅 주소 most common problems treated by ophthalmologists. It is thought that in people with dry eye, t1x 베팅 주소 amount of mucin in t1x 베팅 주소 tear decreases, resulting in instability in t1x 베팅 주소 aqueous layer covering t1x 베팅 주소 mucin layer, leading to damages to t1x 베팅 주소 corneal and conjunctival epit1x 베팅 주소lia. Additionally, people with dry eye suffer from unpleasant sensory symptoms such as "dryness," "foreign body sensation," and "eye pain," as well as subjective symptoms relating to vision, including "difficulty seeing" and "blurred vision." Such symptoms vary considerably in degree but often interfere with dry eye sufferers' daily lives.