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Roche Reports Results of Port Delivery System with Ranibizumab in P-III Archway Study for Neovascular Age-Related Macular Degeneration

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Roche Reports Results of Port Delivery System with Ranibizumab in P-III Archway Study for Neovascular Age-Related Macular Degeneration

Shots:

  • The P-III Archway study involves assessing the efficacy and safety of Port Delivery System with ranibizumab (PDS)- refilled q6w at fixed intervals vs monthly IVT of ranibizumab (0.5mg) in 418 people with nAMD
  • The P-III Archway study resulted in meeting its 1EP i.e. patients achieved visual acuity outcomes equivalent and is well tolerated with a favorable benefit-risk profile. The 1EP is changed in BCVA score @36wks. & @40wks. while 2EPs include safety; overall change in BCVA from baseline; and change from baseline in center point thickness over time
  • Additionally- the Portal study is evaluating the long-term safety and tolerability of PDS for nAMD. PDS is a permanent refillable eye implant- designed to continuously release a customized formulation of ranibizumab into the eye over time

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Ref: Roche | Image: Roche


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