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news.Novartis' eye drug Lucentis has received EU approval as a new treatment for patients with wet age-related macular degeneration, the first drug to improve vision in this patient population.
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Until now, available therapies have only been able to slow the decline in vision, not to improve it. Lucentis is the first therapy shown in clinical trials to improve vision and vision-related quality of life in a significant number of people suffering from wet age-related macular degeneration (AMD).
“We now look forward to regulatory authorities in the EU member states continuing to recognize the value of Lucentis by reimbursing it as quickly as possible to avoid unnecessary blindness,” said MacDonald Curran, chairman of AMD Alliance International.
The studies used in the regulatory submissions for Lucentis show an unprecedented response rate among wet AMD patients. Approximately 95% of Lucentis-treated patients maintained their vision, as defined by a loss of less than 15 letters in visual acuity on the study eye chart.
More than 68% of Lucentis-treated patients gained some vision, which is defined as any increase above baseline visual acuity. To date, this gain in vision has been sustained at two years with monthly Lucentis treatment.
Novartis will launch Lucentis in European countries throughout 2007 and 2008. Novartis has clinical trials underway to evaluate the safety and efficacy of Lucentis in other eye diseases, such as diabetic macular edema.