pan (2014) as Lucentis has been approved by Japanese regulatory bodies for the treatment of patients with diabetic macular edema (DME) (Press release Novartis, FEB 20, 2014, View Source [SID:1234500112]).
Approval of Lucentis was based on results from the REVEAL trial, the first randomized clinical trial specifically designed to assess the efficacy and safety of Lucentis in Asian patients with visual impairment due to DME. In this Phase III trial, 396 patients from six countries, including Japan, were initially treated with monthly injections of 0.5 mg Lucentis, 0.5 mg Lucentis plus laser treatment or laser treatment alone for two months. Treatment was continued for twelve months if stable vision was not reached.
Efficacy and safety results from the REVEAL study were similar to other DME trials primarily conducted in Caucasians. At twelve months, REVEAL confirmed the superior efficacy of Lucentis with rapid and sustained visual acuity gains compared with laser therapy. Safety results showed that Lucentis was well tolerated in patients with DME both as monotherapy or when administered together with laser.

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