Otsuka Pharmaceutical Co., Ltd.

October 1, 2015

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

  • Carteolol hydrochloride/ Latanoprost was developed as a fixed combination ophthalmic solution of carteolol hydrochloride, a non-selective beta-blocker originally developed by Otsuka Pharmaceutical, and latanoprost, the most widely used prostaglandin analogue.
  • Although a monotherapy is generally used as the initial treatment for glaucoma, if a sufficient decrease in intraocular pressure is not achieved, in many cases a combination of multiple drugs is used. Unfortunately, the need to instill multiple drugs in sequence leads to reduced patient adherence due to its inconvenience, resulting in decreased treatment efficacy. Thus, fixed combination ophthalmic solutions are important for ensuring treatment efficacy.
  • Glaucoma is a progressive and irreversible disease and a major cause of blindness. It is estimated that there are approximately 540,000 glaucoma patients currently being treated in Japan, and with the aging population that number is expected to steadily increase. There is a need for more effective treatments, as well as for treatment regimens that will improve patient adherence.

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.