Two-year results of the Archway study showed vision was maintained by Susvimo pts and continued to be non-inferior to monthly ranibizumab injections. In addition, 95% of Susvimo pts were able to go six months without needing additional treatment in the second, third and fourth refill-exchange intervals. It was generally well tolerated and had a favourable safety profile 
The US Prescribing label for Susvimo has a black box warning for 3-fold higher rate of endophthalmitis with the port delivery system vs monthly ranibizumab injections. In clinical trials, 2% of patients receiving an implant experienced an episode of endophthalmitis .
First patient enrolled in PIII Velodrome study .
PIIIb VELODROME trial (NCT04657289; Study WR42221) is planned to start recruiting May 2021 (n=442). This global, multicentre, randomised, visual assessor-masked study is designed to assess the efficacy, safety, and pharmacokinetics of the Port Delivery System with ranibizumab (PDS) 100 mg/mL delivered every 36 weeks (Q36W) compared with every 24 weeks (Q24W) in patients with neovascular age-related macular degeneration (nAMD). The study is expected to complete in Sep 2023 .
Positive topline results from the randomised, multicentre, open-label PIII Archway study reported the primary endpoint was met among pts with the PDS who received refills every 6 months. The PDS was also generally well-tolerated with a favorable benefit-risk profile. The primary endpoint of the trial was the change in BCVA from a baseline at the average of Week 36 and Week 40.
Recruitment completes in PIII Archway study .
PII LADDER study published in Ophthalmology 2019. pii: S0161-6420(18)33328-1 .
Positive primary data from LADDER study presented at ASRS 2018 .
First patient enrolled in PII/III Portal extension study (NCT03683251). 500 patients from LADDER or Archway will receive refills of 100mg/ml ranibizumab every 24 weeks; patients without the PDS will receive the PDS and subsequent refills. Primary outcome is safety .
First patient enrolled in PIII Archway study (NCT03677934). 360 patients will be randomised to the ranibizumab PDS every 24 weeks or intravitreal ranibizumab every 4 weeks. Primary outcome is change in BCVA from baseline at the average of week 36 and week 40 .
PII LADDER trial completes collection of primary outcome data .
Recruitment complete in PII LADDER study .
PII LADDER trial starts (NCT02510794). This is a 4-arm study in which 200 patients will be randomised to one of three ranibizumab formulations delivered via implant or Lucentis monthly intravitreal control injections. Primary outcome is time to first refill .