GLANATEC® ophthalmic solution 0.4%
|Target disease||Glaucoma / Ocular hypertension|
|Development stage||Launched in Japan
Approval of New Drug Application in Korea, Singapore, Malaysia and Thailand
Filed in Vietnam
|License out to||Kowa Company, Ltd. ( Product : K-115 )|
|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)”.
After approval of New Drug Application in Japan, consideration for overseas sales is underway.
|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|
|2019||Feb.||Approval of New Drug Application in Korea|
|2020||Mar.||Approval of New Drug Application in Singapore|
|Jul.||Approval of New Drug Application in Malaysia|
|Aug.||Approval of New Drug Application in Thailand|
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
Combination eye drop of Ripasudil hydrochloride hydrate and Brimonidine tartrate
From February 2020, phase III clinical study in Japan of combination eye drop of Ripasudil hydrochloride hydrate and Brimonidine tartrate was initiated (development code : K-232). This combination eye drop is the first combination eye drop containing Ripasudil hydrochloride hydrate and is expected to improve adherence. We believe that it can contribute to the treatment of glaucoma patients.
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.