Roche Reports Results of Port Delivery System with Ranibizumab in P-III Archway Study for Neovascular Age-Related Macular Degeneration
Roche Reports Results of Risdiplam in SUNFISH Part 2 Study for Patients with Type 2 Or 3 Spinal Muscular Atrophy
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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