Marketing Approval of 『LUMIGAN Ophthalmic Solution 0.03%』 as a treatment for Glaucoma / Ocular Hypertension | News | SENJU Pharmaceutical

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July 8, 2009

Marketing Approval of 『LUMIGAN Ophthalmic Solution 0.03%』 as a treatment for Glaucoma / Ocular Hypertension

Senju Pharmaceutical Co., Ltd (SENJU) today announces that the Japanese Ministry of Health, Labour and Welfare has approved the New Drug Application (NDA) for “LUMIGAN Ophthalmic Solution 0.03%” (bimatoprost ophthalmic solution) in the treatment of glaucoma/ocular hypertension.

Bimatoprost was synthesized by Allergan Inc. (USA) and is a prostamide analog, structurally related to prostamide (endogenous physiological active substance), which is different from the existing marketed prostaglandin analogs. Bimatoprost ophthalmic solution is already marketed in 73 countries and areas including the USA and Europe as of February 2008.

 

“LUMIGAN Ophthalmic Solution 0.03%” showed a stable IOP-lowering effect during long-term use, and neither ocular nor systemic serious adverse drug reactions in patients with primary open angle glaucoma (POAG), ocular hypertension (OH) or normal tension glaucoma (NTG).

 

Summary of approval for “LUMIGAN Ophthalmic Solution 0.03%” is as follows

    Approval dateJuly 7, 2009

    Product name”LUMIGAN Ophthalmic Solution 0.03%”

    Nonproprietary nameBimatoprost

    Contents and formulationBimatoprost 0.3mg/mL, sterile ophthalmic solution

    IndicationsGlaucoma and Ocular Hypertension

    Dosage and administrationOne drop once daily

    Characteristics of “LUMIGAN Ophthalmic Solution 0.03%”

(1)“LUMIGAN Ophthalmic Solution 0.03%” is a synthetic prostamide analog with a potent andstable IOP-lowering effect.

(2)In patients with POAG or OH treated with “LUMIGAN Ophthalmic Solution 0.03%” for 12 weeks in a clinical study, the average rate of the change from the baseline in IOP is around a 33% reduction, and the percentage of patients who achieved a 30% reduction of IOP from the baseline is around 70%.

(3)In patients with POAG or OH treated with “LUMIGAN Ophthalmic Solution 0.03%” in a long-term clinical study, a strong IOP-lowering effect (of which the average rate of change from the baseline in IOP is around a 33% reduction) was continuously shown.

(4)Neither ocular nor systemic serious adverse drug reactions were observed.

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