FDA accepts application for Roche Port Delivery System with ranibizumab for macular degeneration

 

• If approved, PDS would be the first and only eye implant with continuous drug delivery that offers people living with nAMD an alternative to frequent eye injections
• A pivotal study showed PDS extends time between treatments up to six months for more than 98% of patients and provides vision outcomes equivalent to monthly ranibizumab injections
• The European Medicines Agency has also validated the PDS Marketing Authorisation Application in nAMD

https://www.globenewswire.com/news-release/2021/06/24/2252252/0/en/FDA-accepts-application-for-Roche-s-Port-Delivery-System-with-ranibizumab-PDS-for-treatment-of-neovascular-or-wet-age-related-macular-degeneration-nAMD.html