image credit: Unsplash

Roche eyes October decision by FDA for wet AMD implant

June 24, 2021


The port delivery system (PDS) formulation of ranibizumab – a VEGF inhibitor already approved as Lucentis to treat wet AMD – was able to extend the time between treatments for six months or more in 98% of patients in a phase 3 trial, with no loss of efficacy.

The FDA has started a priority, six-month review of the marketing application, so Roche should get a decision on the application by October 23, barring any delays. Ranibizumab PDS is also under review by the EMA in Europe.

Read More on Pharmaphorum