Novartis-Genentech’s DME drug Lucentis gets approval in Japan

Novartis and Genentech have jointly developed Lucentis, which is claimed to be the first anti-VEGF therapy approved for DME in Japan.

Genentech has the commercial rights of the drug in the US, while Novartis has exclusive rights in the rest of the world.

Currently, laser therapy is the current standard of care in Japan and it has provided stabilization of vision in many patients, but generally does not improve vision.

Novartis Pharmaceuticals global head of Development Tim Wright 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," Wright said.

The Japanese approval of Lucentis was based on results from the REVEAL trial, the first randomized clinical trial designed to evaluate the efficacy and safety of Lucentis in Asian patients with visual impairment due to DME.

About 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 after treatment, it was continued for an additional twelve months.

The efficacy and safety results of the REVEAL trial were similar to other DME trials previously carried out in Caucasian and they showed that Lucentis was well tolerated in patients with DME both as monotherapy or when administered together with laser.