The Japanese regulatory bodies have approved Lucentis (ranibizumab) for a fourth indication for treatment of patients with diabetic macular edema (DME), a major cause of vision loss among diabetic patients.
Jointly developed by Genentech and Novartis, Lucentis is the first anti-VEGF therapy approved for diabetic macular edema (DME) in Japan.
In the US, Genentech has the commercial rights of the drug, while Novartis has exclusive rights in the rest of the world.
Laser therapy is the current standard of care in Japan, which has provided stabilisation of vision in many patients, but generally does not improve vision.
Novartis Pharmaceuticals global head of development Tim Wright said: "Now Japanese patients living with DME have access to Lucentis, a drug with an unsurpassed efficacy and safety profile across multiple indications."
Approval was based on results from the REVEAL trial, the first randomised clinical study designed to evaluate the efficacy and safety of Lucentis in Asian patients with visual impairment due to DME.
A total of 396 patients from six countries, including Japan, were initially treated in the Phase III trial with monthly injections of 0.5mg Lucentis, 0.5mg Lucentis plus laser treatment or laser treatment alone for two months.
If stable vision was not reached, treatment was continued for an additional 12 months.
The efficacy and safety results of the REVEAL trial were similar to other DME trials primarily conducted in Caucasians.
At 12 months, the REVEAL trial confirmed the superior efficacy of Lucentis with rapid and sustained visual acuity gains compared with laser therapy.
Safety results of the trial demonstrated that Lucentis was well-tolerated in patients with DME both as monotherapy or when administered together with laser.
According to Novartis, Lucentis was specifically designed, developed and formulated for ocular conditions. It is licensed in more than 100 countries.
Image: Diabetic macular edema. Photo: courtesy of National Eye Institute, National Institutes of Health.