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  5. New Drug Application for Carteolol Hydrochloride/ Latanoprost, a Novel Combined Ophthalmic Solution, Submitted in Japan for the Treatment of Glaucoma and Ocular Hypertension

October 1, 2015

Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals

New Drug Application for Carteolol Hydrochloride/ Latanoprost, a Novel Combined Ophthalmic Solution, Submitted in Japan for the Treatment of Glaucoma and Ocular Hypertension

Otsuka Pharmaceutical Co., Ltd., announced that it has submitted a new drug application to the Japanese Ministry of Health, Labour and Welfare for regulatory approval of, carteolol hydrochloride/ latanoprost, a novel combined ophthalmic solution.

Carteolol hydrochloride/ latanoprost is a fixed combination ophthalmic solution containing two active ingredients with different mechanism of actions: carteolol hydrochloride 2% and latanoprost 0.005%, both of which have been proven to be effective and safe. The unique characteristic of carteolol hydrochloride/ latanoprost is that it also includes alginate, an agent that sustains carteolol hydrochloride's efficacy in decreasing intraocular pressure. Carteolol hydrochloride is a non-selective beta-blocker developed by Otsuka Pharmaceutical that decreases intraocular pressure by suppressing aqueous humor formation in the ciliary epithelium. The other active ingredient, latanoprost, is a prostaglandin analogue (PGF analogue) that accelerates the uveoscleral outflow of aqueous humor by activating prostanoid FP receptors. Latanoprost is currently the most widely used treatment for glaucoma and ocular hypertension due to its high efficacy and convenient once-daily dosing regimen. When using a combination of multiple ophthalmic solutions, patients are required to wait a specified length of time between the instillation of each drug, making the treatment regimen complicated and inconvenient. The availability of a fixed combination ophthalmic solution is expected to improve patient adherence and thus result in improved treatment efficacy.


Information in this news release was current as of the original release date.

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