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 prostamideＦ2α (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
“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 date：July 7, 2009
・Product name：”LUMIGAN Ophthalmic Solution 0.03%”
・Nonproprietary name：Bimatoprost
・Contents and formulation：Bimatoprost 0.3mg/mL, sterile ophthalmic solution
・Indications：Glaucoma and Ocular Hypertension
・Dosage and administration：One 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.