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 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 and
(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.
