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

Approval of New Drug Application 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)”.
A New Drug Application had submitted in Korea by Kowa Co., Ltd. in December 2017 and it was approved in February 2019.

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 in Korea
2019 Feb. Approval of New Drug Application 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

aqueous_img

Review of Extension of GLANATEC® ophthalmic solution 0.4% Indication

From February 2014, exploratory clinical pharmacology tests had been conducted for GLANATEC® ophthalmic solution 0.4% by Kowa Co., Ltd. for diabetic retinopathy patients with diabetic macular edema. (Development code: K-115-R)
Diabetic retinopathy is a disease in which the retina impaired due to diabetes and causes to the vision declines and blindness. Future development policy is currently being considered by Kowa Co., Ltd.

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D.Western Therapeutics Institute, Inc.
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Nagoyashi, Aichi 460-0003 Japan
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