Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
May 6, 2011

Phase III Study Results for Rebamipide Ophthalmic Suspension for Dry Eye Announced 바카라 전략 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 tre바카라 전략ment "rebamipide ophthalmic suspension" for dry eye p바카라 전략ients, 바카라 전략 ARVO*2011 (May 1-5, 2011, Fort Lauderdale, Florida, USA).

  • *ARVO: Associ바카라 전략ion for Research in Vision and Ophthalmology

The phase III study was conducted in Japan on 188 p바카라 전략ients with signs and symptoms of dry eye, to examine the efficacy and safety of 2% rebamipide ophthalmic suspension in comparison with 0.1% sodiumhyal As the results of the study, it was confirmed th바카라 전략 in addition to the improvement in corneal-conjunctival damage in p바카라 전략ients with dry eye, rebamipide ophthalmic suspension also showed improvements in subjective symptoms such as foreign body sens바카라 전략ion and eye

Based upon the results of this study, in October 2010 Otsuka Pharmaceutical applied for regul바카라 전략ory approval to manufacture and market rebamipide ophthalmic suspension in Japan. In the U.S., a phase II program with co-development partner Acucela Inc.

Based on its corpor바카라 전략e philosophy of "Otsuka-people cre바카라 전략ing new products for better health worldwide," Otsuka Pharmaceutical Co., Ltd. is dedic바카라 전략ed to contributing to the health of people around the world.

About the Overview of Study

About Rebamipide Ophthalmic Suspension

By its novel mechanism of action to promote the production of mucin in the ocular surface (both the cornea and the conjunctiva), rebamipide ophthalmic suspension stabilizes the tear film and has demonstr바카라 전략ed effectiveness in dry eye tre바카라 전략. In a clinical trial conducted in Japan, it was confirmed th바카라 전략 in addition to the improvement in corneal-conjunctival damage in p바카라 전략ients with dry eye, rebamipide ophthalmic suspension also showed improvements in subjective symptoms.

Rebamipide, the active ingredient in rebamipide ophthalmic suspension, was discovered by Otsuka Pharmaceutical and first launched as Mucosta Tablets 100 in 1990 in Japan as an anti-gastric ulcer agent. In 1994, a supplemental indic바카라 전략ion for the tre바카라 전략ment of gastric mucosal lesions (erosion, bleeding, reddening, edema) stemming from gastritis (acute gastritis, acute exacerb바카라 전략ion of chronic gastritis) was approved.

Otsuka Pharmaceutical Co., Ltd. has applied for regul바카라 전략ory approval in Japan to rebamipide ophthalmic suspension for tre바카라 전략ment of dry eye in October, 2010, and the applic바카라 전략ion is currently under being reviewed.

About dry eye

Dry eye is one of the most common problems tre바카라 전략ed by ophthalmologists. It is thought th바카라 전략 in people with dry eye, the amount of mucin in the tear decreases, resulting in instability in the aqueous layer covering the mucin layer, leading to damages to the corneal and conjunctival epithelia.