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Alcon receives two Japanese drug approvals
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FORT WORTH, Texas — Alcon Inc. has received Japanese marketing approval for two of its ophthalmic drug solutions, the company announced.
Japan’s Ministry of Health, Labor and Welfare approved Patanol (olopatadine hydrochloride 0.1 %) for allergic conjunctivitis. It also approved Vegamox (moxifloxacin hydrochloride 0.5%) for treating ocular bacterial infections, including conjunctivitis and keratitis, as well as for surgical prophylaxis, according to two Alcon press releases.
Patanol provides both mast-cell stabilizing and antihistamine properties in a single molecule, providing patients with rapid, lasting relief from the signs and symptoms of allergic conjunctivitis, according to one release.
Vegamox is a newer generation fluoroquinolone with a near-neutral pH of 6.8, which provides for ocular comfort. In clinical studies, Vegamox showed excellent efficacy and therapeutic penetration, company officials said.
Scott Manning, president of Alcon Japan, said that the approvals will present an opportunity for increased sales in Japan, the world’s second-largest market for both ocular anti-infectives and ocular allergy products.
Alcon officials anticipate launching both Patanol and Vegamox in Japan this year.
Patanol is currently approved in 83 countries, including the United States. Vegamox is currently approved in more than 40 countries under the name of Vigamox.