D.Western Therapeutics Institute,Inc.is a biotechnology company that focuses on development of innovative new drags to serve patients worldwide.

GLANATEC® ophthalmic solution 0.4%

GLANATEC® ophthalmic solution 0.4%

Target disease Glaucoma / Ocular hypertension
Development stage Launched in Japan

Filed in Korea

License out to Kowa Company, Ltd.
Overview glaucoma & ocular hypertension treatment drug in the clinical studies conducted in the patients with primary open-angle glaucoma and ocular hypertension in Japan. Launched in December 2014 in Japan. Brand name is “GLANATEC® ophthalmic solution 0.4% (nonproprietary name: Ripasudil hydrochloride hydrate)”.

Kowa Co., Ltd. filed for manufacturing and marketing approval in Korea in December 2017.

Development Progress

2002 Sep. Licensed all worldwide rights to Kowa Company, Ltd.
2006 Jul. Initiated phase I trial in Japan
2007 Oct. Completed phase I trial in Japan
2009 Mar. Initiated phase II trial in Japan
2011 Jan. Completed phase II trial in Japan
Sep. Initiated phase III trial in Japan
2013 Apr. Completed phase III trial in Japan
Oct. Filed NDA application in Japan
2014 Sep. Acquired Marketing Approval in Japan
Dec. Launched in Japan
2017 Dec. Filed manufacturing and marketing approval in Korea.

GLANATEC® ophthalmic solution 0.4% Point of Action

Glaucoma is said to develop (*) due to increased ocular pressure, and the glaucoma drug works to decrease ocular pressure. The eye ball is filled with fluid, called aqueous humor to keep ocular pressure. The aqueous humor is produced in the ciliary body and goes through the uveoscleral outflow and Schlemm’s canal outflow before discharged out of the eye. GLANATEC® ophthalmic solution 0.4% promotes outflow of aqueous humor through Schlemm’s canal.

*Glaucoma may develop even if the ocular pressure is in the normal range.

 Aqueous Humor Flow


Review of Extension of GLANATEC® ophthalmic solution 0.4% Indication

In February 2014, a phase II clinical study on GLANATEC® ophthalmic solution 0.4% initiated in diabetic retinopathy accompanying diabetic macular edema(Development Code:K-115-R).
Diabetic retinopathy is a disease in the retina damaged by diabetes, leading to decreased visual acuity and to blindness. The phase II clinical study is under evaluation of the effects of improvement in this disease when instilling GLANATEC® ophthalmic solution 0.4% which was developed as a glaucoma drug having Rho kinase inhibitory action.

D.Western Therapeutics Institute, Inc.
1-18-11, Nishiki, Naka-ku,
Nagoyashi, Aichi 460-0003 Japan
TEL 81+52-218-8785
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