The company chose to withdraw the application for Retaane 30mg/ml (anecortave acetate suspension for depot injection) after being informed by the EMEA that it would have to provide additional clinical data from existing and/or new clinical trials to support approval.
The FDA also recently advised the company that additional clinical data will be required for US approval.
Alcon said it is revising its clinical strategy and plans to continue developing Retaane suspension for wet age-related macular degeneration (AMD) in the US, Europe and key markets around the world.
The company said it would provide a timeframe for resubmission or amendment after it finalizes the revised clinical development strategy.
Although the news from US and European regulators has not been good so far, Australia’s Therapeutic Goods Administration (TGA) has approved a version of Retaane, namely 15mg anecortave acetate suspension, for the treatment of subfoveal choroidal neovascularization (CNV) due to exudative AMD where there is a classic component.