Novartis announced that Lucentis (ranibizumab) has been approved by Japanese regulatory bodies for a fourth indication: the treatment of patients with diabetic macular edema (DME), a leading 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.

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

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[3],[4]. 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.

Lucentis was designed to save sight and has demonstrated transformational efficacy with individualized dosing in its licensed indications. As an antibody fragment with a short systemic half-life, Lucentis was specifically designed, developed, formulated and licensed for ocular conditions, and is manufactured to the highest standards for intra-ocular use.

Lucentis is licensed in more than 100 countries, for the treatment of wet AMD, visual impairment due to DME and for visual impairment due to macular edema secondary to RVO, including both branch- and central-RVO. Also, Lucentis is licensed in more than 40 countries for the treatment of patients with visual impairment due to CNV secondary to pathologic myopia (myopic CNV). In most countries, including those in Europe, Lucentis has an individualized treatment regimen with the goal of maximizing visual outcomes while minimizing under- or over-treating patients.

Lucentis has a well-established safety profile supported by 43 extensive sponsored clinical studies and real-world experience. Its safety profile has been well established in a clinical development program that enrolled more than 12,500 patients across indications and there is more than 2.2 million patient-treatment years of exposure since its launch in the United States in 2006.

Lucentis was developed by Genentech and Novartis. Genentech has the commercial rights to Lucentis in the United States. Novartis has exclusive rights in the rest of the world. Lucentis is a registered trademark of Genentech Inc.

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