Alcon Laboratories has decided to withdraw its application in Europe to market age-related macular degeneration drug Retaane, after being asked to provide more clinical data to support approval.
Last year, the US Food and Drug Administration issued an ‘approvable’ letter for Retaane (anecortave acetate suspension for depot injection) which also asked for additional clinical data in the treatment of wet AMD, a leading form of blindness. The product has already been approved for sale in Australia.
The company said it is revising its clinical strategy and plans to continue developing Retaane suspension for wet age-related macular degeneration in the USA, Europe and key markets around the world. It added that it would provide a timeframe for resubmission or amendment after it finalises the revised clinical development strategy.
In December, Alcon said it had signed an agreement with the National Eye Institute (NEI) in the US to supply Retaane for a clinical trial that will investigate the long-term safety and potential efficacy of the drug in patients with all forms of wet AMD who are undergoing intravitreal therapy with Genentech’s Avastin (bevacizumab).