Shots:

• The BLA submission is based on results from the P-III Archway study involves assessing PDS with ranibizumab- refilled @6mos. at fixed intervals- vs ranibizumab (0.5mg- monthly IVT) in 418 patients with nAMD- prior treated with VEGF therapy
• Results: 98.4% of PDS patients were able to go 6mos. without needing additional treatment & achieved vision outcomes equivalent to patients receive ranibizumab (0.5mg- monthly IVT) & PDS showed non-inferiority & equivalent to monthly ranibizumab in a pre-specified study- well-tolerated with favorable benefit-risk profile
• The EMA has also validated the PDS’ MAA & is currently under review while FDA expects to decide on approval by Oct 23- 2021

  Ref: Roche | Image: Roche