Lucentis earns DME indication in European Union

BASEL, Switzerland — The European Commission has granted ranibizumab a new indication for treating diabetic macular edema, Novartis announced in a press release.

Lucentis (ranibizumab, Genentech) stands as the first licensed therapy to significantly improve vision and vision-related quality of life among patients with DME, the release said.

The approval follows Novartis' submission of data from its RESTORE and RESOLVE clinical trials, both of which demonstrated the superiority of ranibizumab over sham and laser therapy for improving visual acuity among patients with DME.

Specifically, the RESTORE study found that patients treated with ranibizumab monotherapy or with ranibizumab in combination with laser therapy experienced an average visual acuity gain of 6.8 letters and 6.4 letters, respectively, at 12 months, compared with an average gain of 0.9 letters among patients treated with laser monotherapy. The RESOLVE study showed that patients who received ranibizumab gained an average of 10.3 letters at 12 months, compared with a loss of 1.4 letters among patients who received sham or sham combined with laser treatment, the release said.

The approval was also supported by results from the Diabetic Retinopathy Clinical Research Network, which showed that patients treated with ranibizumab and laser therapy gained an average of nine letters while patients treated with laser monotherapy gained an average of three to four letters at 12 months, with ranibizumab-treated patients showing superior visual acuity gains that persisted for up to 2 years. In addition, ranibizumab-treated patients required a median of two to three injections during the second year of treatment, compared with a median of eight or nine injections during the initial year of treatment.

In all DME trials, there was a 3.5% or less incidence of arterial thromboembolic events and a 1.4% incidence of endophthalmitis. Both incidences were consistent with reported rates in clinical trials of the drug in AMD patients, according to the release.

Genentech plans to release results from its phase 3 RISE and RIDE clinical trials of ranibizumab in DME later this year.