September 21, 2018 - Santen Pharmaceutical Co., Ltd. (Head Office: Osaka; hereinafter, “Santen”) and Ube Industries, Ltd. (Head Office: Ube; hereinafter, “Ube Industries”) announced today that Santen has received manufacturing and marketing approval of glaucoma and ocular hypertension treatment EYBELIS Ophthalmic Solution 0.002% (development code: DE-117; JAN*: Omidenepag Isopropyl; hereinafter, “EYBELIS”) in Japan.
Santen and Ube Industries co-developed EYBELIS as a treatment for glaucoma and ocular hypertension. Omidenepag Isopropyl, the active pharmaceutical ingredient in EYBELIS, is a selective EP2 receptor agonist and is a new mechanism of action as an ocular hypotensive agent.
Glaucoma is a disorder which causes optic nerve damage leading to visual field loss, and is a major cause of visual impairment including decreased vision and blindness in Japan. Since glaucomatous optic nerve damage and visual field defects are generally progressive and irreversible, early detection and treatment for controlling progression of damage is crucial in the treatment of glaucoma. EYBELIS is shown to contribute to the lowering of intraocular pressure (IOP), the most effective means of avoiding glaucomatous damage.
Santen and Ube Industries will make EYBELIS available in medical settings as a new treatment option, and will provide drug safety information for patients and healthcare professionals, in order to promote understanding of the appropriate use of EYBELIS, thereby enhancing patients' quality of life.
EYBELIS is a product in global development, and is currently in Phase 3 trials in Asia (outside Japan). Phase 3 trials for EYBELIS in the U.S. are scheduled to start in the second half of fiscal 2018.
* Japanese Accepted Names for Pharmaceuticals
|Product name||EYBELIS Ophthalmic Solution 0.002%|
|Dosage form||Sterilized aqueous ophthalmic solution|
|Indication||Glaucoma and ocular hypertension|
|Dosage||1 drop/time, once daily|
As a specialized company dedicated to ophthalmology, Santen carries out research, development, marketing, and sales of pharmaceuticals, over-the-counter products, and medical devices. Santen is the market leader for prescription ophthalmic pharmaceuticals in Japan and its products now reach patients in over 60 countries. With scientific knowledge and organizational capabilities nurtured over a nearly 130-year history, Santen provides products and services to contribute to the well-being of patients, their loved ones and consequently to society. For more information, please visit Santen’s website (www.santen.com).
Centering on Chemicals business, Ube Industries operates Pharmaceutical / Cement & Construction Materials / Machinery / Energy & Environment businesses. Among them, the pharmaceutical business is positioned as one of active growth businesses of the company. Ube Industries endeavors to expand the pharmaceutical business by both "drug discovery" by its own / joint research and development, and "manufacturing of APIs and intermediates." For more details, please see Ube Industries' website (http://www.ube-ind.co.jp/ube/en/).
Information provided in this press release contains forward-looking statements. The achievement of these forecasts is subject to risk and uncertainty from various sources. Therefore, please note that the actual results may differ significantly from the forecasts. Business performance and financial conditions are subject to the effects of changes in regulations made by the governments of Japan and other nations concerning medical insurance, drug pricing and other systems, and to fluctuations in market variables such as interest rates and foreign exchange rates.