EMERYVILLE, Calif. & UBE, Japan–( BUSINESS WIRE )–Santen Inc., the U. S. subsidiary of Santen Pharmaceutical Co., Ltd. (Santen), and UBE Corporation (UBE) today announced that the U. S. Food and Drug Administration (FDA) has approved OMLONTI ® (omidenepag isopropyl ophthalmic solution) 0. 002% eye drops for that reduction associated with elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension. The approval date was September 22.
OMLONTI ® is developed jointly by Santen and UBE. Omidenepag isopropyl, the active pharmaceutical ingredient in OMLONTI ® , developed by UBE, is a relatively selective prostaglandin EP2 receptor agonist, which increases aqueous humor drainage through the conventional (or trabecular) plus uveoscleral outflow pathways, and the only product with this pharmacological action. OMLONTI ® was launched inside Japan as Eybelis ® ophthalmic solution 0. 002% in November 2018, and was filed for marketing approval in Asian countries inside stages. The particular product was released in five countries and regions beginning in February 2021.
“Glaucoma prevalence is increasing as the particular global population ages. Supporting patients simply by protecting vision across the continuum of clinical care within glaucoma is a significant aim with regard to Santen to reduce the social plus economic opportunity loss of people around the world caused by vision conditions, ” explains Peter Sallstig, Chief Medical Officer of Santen. “This approval is an important milestone in our ambition to tackle unmet needs in attention health and advances our goal of realization of “Happiness with Vision”. It also represents our first glaucoma offering in the Oughout. S. We are pleased to provide doctors and individuals in the particular U. S. with a new option to help control IOP for the more than three million Americans affected by glaucoma 1 or ocular hypertension. ”
“UBE Corporation is committed to working on new drug discoveries on a daily basis with the particular aim of providing patients along with more treatment options for diseases with high unmet requirements, ” said Yoichi Funayama, Senior Executive Officer and General Manager of the Pharmaceutical Division, UBE Corporation. “We are very pleased that this particular ophthalmic answer has been approved for glaucoma within the You. S., following approvals in Japan plus Asia. We have high expectations that omidenepag isopropyl will provide a new treatment option for more patients suffering from glaucoma and ocular hypertension through Santen. ”
OMLONTI ® was evaluated inside three randomized and controlled clinical trials in subjects with open-angle glaucoma or even ocular hypertension with average baseline IOP of 24-26 mm Hg. The double-masked treatment duration was three months in all three studies. The third study included a 9-month open-label treatment period following the 3-month double-masked therapy period. In the 3 studies, IOP reductions were observed for all treatment arms. In the particular OMLONTI ® arm, the reduction in IOP ranged from 5-7 mm Hg across almost all three research. The corresponding reductions regarding the timolol and latanoprost arms had been 5-7 mm Hg and 6-8 millimeter Hg, respectively.
Glaucoma causes damage in order to the optic nerve resulting in visual field loss, and remains a leading cause of irreversible blindness worldwide. 2 Since the disease is generally progressive, early detection and treatment to control the particular progression are usually crucial, plus lowering IOP is the most effective means associated with avoiding damage to the particular optic nerve. The estimated number of patients globally in 2020 was 76 million, and it will be expected to increase to 95 million by 2030. 3 Primary open-angle glaucoma is the most common type of glaucoma. Ocular hypertonus, which affects millions, can lead to glaucoma plus vision reduction if untreated. 4
“Treatments that focus on IOP reduction help to slow or prevent further loss associated with vision intended for those with glaucoma or even ocular hypertonie. However, not all patients respond to the same treatments, and some may not have successful outcomes, ” said Jason Bacharach, MD, Medical plus Research Director at North Bay Eye Associates, Incorporation. “The approval of omidenepag isopropyl ophthalmic solution 0. 002% provides doctors along with another safe and efficient option to use when treating patients with these sight-threatening conditions. ”
Indication
OMLONTI ® (omidenepag isopropyl ophthalmic solution) 0. 002%, is the relatively picky prostaglandin E2 (EP2) receptor agonist, indicated for your reduction of elevated intraocular pressure (IOP) in patients along with open-angle glaucoma or ocular hypertension.
IMPORTANT SAFETY INFORMATION
The safety of OMLONTI ® offers been evaluated in 12 clinical studies, 10 of which investigated the safety of OMLONTI ® in QD dosing. The results from these clinical tests indicate that will OMLONTI ® is safe and well tolerated by adult subjects (N=1111) with a diagnosis of open-angle glaucoma or ocular high blood pressure, and simply by pediatric topics (N=6) with juvenile open-angle glaucoma. The risks identified with instillation of OMLONTI ® include macular edema, including CME, in sufferers with aphakia, pseudophakia, or even other risk factors to get macular edema; ocular inflammation; the possibility of increased eye pigmentation; and eyelash changes.
About Santen
As a global specialized company dedicated to eye health, Santen brings a more than 130-year history of scientific knowledge plus organizational capabilities to research, development, and commercialization of pharmaceutic, surgical, and OTC eyesight care products. Santen is the market leader pertaining to prescription ophthalmic pharmaceuticals within Japan, plus its products now reach patients in more than 60 countries. Santen provides products and services to contribute to the well-being of patients, their loved ones, and consequently to society. For a lot more information, please visit Santen’s websites www.santenusa.com and www.santen.com (Japan headquarters).
Regarding UBE Company
Leveraging the particular manufacturing technologies the UBE groups has cultivated, UBE creates the value required by society, in the safe plus environmentally friendly manner demanded by community, and delivers that value to the people. UBE helps to solve global environmental issues, which have become a common issue for all those humankind, and contribute to people’s lives and health, plus an enriched future modern society. UBE aims to give rise to better wellness for everyone with community-based manufacturing associated with drugs using innovative systems. Going forward, UBE will continue creating promising new compounds for new medicines with a dual approach of pursuing drug discovery via internal and joint research and advancement projects, plus manufacturing and supply associated with APIs plus intermediates. For more details, please see UBE Corporation’s website ( http://www.ube-ind.co.jp/ube/en/ ).
Forward-looking Statements
Information provided in this press release contains forward-looking statements. The achievement of these forecasts is subject to danger and uncertainty from various sources. Therefore , please note that the actual results may differ significantly from the forecasts. Company performance and financial conditions are subject matter to the effects of changes in regulations made by the governments of Japan and other nations concerning medical insurance, medicine pricing plus other systems, and in order to fluctuations within market variables such as interest rates and foreign exchange rates.
one Glaucoma Research Foundation. Glaucoma Facts plus Stats. Available at https://www.glaucoma.org/glaucoma/glaucoma-facts-and-stats.php . Accessed September 22, 2022.
two Quigley HA, Broman AT. The number of people with glaucoma globally in 2010 and 2020. Br J Ophthalmol. 2006; 90(3): 262-267. doi: 10. 1136/bjo. 2005. 081224.
3 World report on eyesight. World Health Organization World report on vision (who. int). Last accessed Sept 22, 2022.
4 American Academy of Ophthalmology. What is Ocular Hypertension. Available at https://www.aao.org/eye-health/diseases/what-is-ocular-hypertension . Accessed September 22, 2022.