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news.Novartis has released initial results of the Restore Phase III study which showed that Ranibizumab is more effective than laser treatment, the current standard of care, in treating visual impairment due to diabetic macular edema (DME).
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Gabriele Lang, head of the division of medical retina and laser surgery of department of ophthalmology at University of Ulm in Germany, has presented the results from the Restore Phase III study at the meeting of the European Association for the Study of Diabetic Eye Complications (EASDec) in Paris.
Novartis said that Ranibizumab has been approved in more than 80 countries for the treatment of wet age-related macular degeneration (AMD) under the brand name Lucentis. It is not currently licensed in any market for the treatment of visual impairment due to DME. An application for marketing approval in this indication was submitted to EU health authorities in December 2009.
Novartis said that results at one year showed that 37% of patients treated with Ranibizumab 0.5mg alone, and 43% of those treated with Ranibizumab plus laser therapy, gained a substantial vision improvement of 10 letters or more on an eye-chart compared to 16% of patients treated with laser alone.
The Restore study showed that over one year, patients treated with Ranibizumab plus laser were able to read an additional 5.9 letters on a standard eye-chart, while those treated with Ranibizumab alone could read 6.1 letters more than at the start of the study. This compared with patients receiving laser therapy alone who could read an additional 0.8 letters. The study met its primary endpoint.
The efficacy and safety data support the results of the pivotal Resolve study comparing Ranibizumab to sham (or dummy) treatment. This demonstrated that 61% of Ranibizumab-treated patients gained 10 letters or more in visual acuity, and formed the basis of the EU submission. The results from Restore also follow a US study conducted by the Diabetic Retinopathy Clinical Research Network (DRCR.net) showing that after one year, nearly 50% of eyes treated with Ranibizumab and laser therapy showed an improvement in vision of 10 letters or more, compared to 28% with laser alone.
Professor Lang said: “These new data showed that treatment with Ranibizumab produced a rapid improvement in visual acuity with sustained benefit.”
Trevor Mundel, MD of global head of development at Novartis, said: “Ranibizumab was specifically designed and licensed for use in the eye, and has already been shown in randomised controlled trials to improve vision in patients with wet AMD.
“These results confirm that it could provide a new therapeutic option for visually impaired patients with DME.”