Novartis' DME Drug Lucentis 4th Indication in Japan Approved

Novartis announced that its application for a fourth indication for Lucentis (ranibizumab) in Japan has been approved by Japanese regulatory authorities. Lucentis can now be used as treatment for diabetic macular edema in Japan.

Tim Wright, global dead of development at 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…now Japanese patients living with DME have access to Lucentis, a drug with an unsurpassed efficacy and safety profile across multiple indications.”

Diabetic macular edema is one of the leading causes of blindness in the working age population in major developed countries. DME results from diabetic retinopathy, the most common diabetic eye complication. It is characterized by changes in the retina blood vessels which can leak in the macula, the central portion of the retina responsible for sharp central vision. DME can lead to visual impairment, which affects an estimated 1-3% of diabetic patients.

The current standard of care for DME in Japan is laser therapy. It provides stabilization but not improvement of vision in patients. Lucentis is the first licensed treatment for vision improvement in Asian patients with DME-related visual impairment.

Approval of Novartis’ Lucentis was based on the REVEAL Phase III trial results, where 396 patients from six countries including Japan were treated with Lucentis, Lucentis plus laser treatment, or laser treatment alone. At twelve months, trial results showed the drug’s superior efficacy with rapid and sustained visual acuity gains compared with laser therapy. Safety data showed the drug was well tolerated in patients with DME both as a monotherapy or in combination with laser therapy.

Lucentis is licensed in over 100 countries for the treatment of visual impairment due to DME, wet AMD, and visual impairment due to macular edema secondary to RVO including both branch- and central-RVO. The drug is also licensed for the treatment of visual impairment due to myopic CNV in over 40 countries. The drug was co-developed by Genentech and Novartis.