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Novartis Announces Lucentis Approval In Fourth Japanese Indication - Quick Facts

Swiss pharma giant Novartis AG (NVS) announced that Lucentis (ranibizumab) has been approved by Japanese regulatory bodies for a fourth indication: to treat patients with diabetic macular edema or DME, a main cause of vision loss among patients with diabetes. Laser therapy, the current standard of care in Japan, has provided stabilization of vision in many patients, but generally does not improve vision. Lucentis is the first licensed therapy to significantly improve vision in Asian patients with visual impairment due to DME.

Tim Wright, Global Head of Development, Novartis Pharmaceuticals, said: "Lucentis has previously been shown to be an effective treatment, improving vision loss and vision-related quality of life for patients with DME." He continued, "Now Japanese patients living with DME have access to Lucentis, a drug with an unsurpassed efficacy and safety profile across multiple indications."

The Lucentis approval as based on the REVEAL trial results, the first randomized study designed specifically to evaluate the efficacy and safety of Lucentis in Asian patients with visual impairment due to DME. Efficacy and safety results from the REVEAL study were similar to other DME trials primarily conducted in Caucasians.

At 12 months, REVEAL confirmed the superior efficacy of Lucentis with rapid and sustained visual acuity gains compared with laser therapy. The safety results demonstrated that Lucentis was well tolerated in patients with DME both as monotherapy or when administered with laser.

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