Roche’s PDS with ranibizumab for nAMD accepted by FDA

The FDA has, under Priority Review, accepted Roche’s Nologics License Application for Port Delivery System with ranibizumab for wet age-related macular degeneration. This condition is the most common cause of blindness in the over 60 age group and there are around 2 million patients worldwide suffering with it. If the FDA grants approval this October, this will become the first treatment to give patients with wet age-related macular degeneration the opportunity to try something other than regular eye injections of anti-vascular endothelial growth factor which is currently the treatment on offer. This new treatment is a tiny permanent refillable eye implant that delivers a constant customised formulation of ranibizumab over several months. The European Medicines Agency has also authorised a Marketing Authorisation Application which is now being reviewed.

Positive results from the phase III Archway study are behind the submission. They suggest that of those nAMD patients being treated with PDS, over 98% could manage 6 months without needing additional treatment before the refill-exchange. These patients also achieved vision outcomes the same as patients on 4 weekly ranibizumab eye injections.

Roche’s Chief Medical Officer and Head of Global Product Development, Levi Garraway, said: “Anti-VEGF therapy brings significant benefit to people with nAMD, but optimal results require frequent trips to the doctor’s office for eye injections. This burden leaves many people under-treated and susceptible to vision loss. If approved, PDS would transform nAMD treatment by providing up to six months of uninterrupted therapy that could potentially improve vision outcomes compared to what is currently achieved in the clinic.”