Genentech has announced successful results for its Phase 3 trial of continuous port delivery system (PDS) administration of Lucentis in wetAMD.
The PDS is a permanent, refillable implant the approximate size of a rice grain, that provides continuous drug delivery into the eye over time.
In the Phase 3 trial in 418 patients, the PDS, when refilled at 6 month intervals, demonstrated non-inferior and equivalent efficacy compared to the standard of care – monthly Lucentis eye injections.
Genentech plans to submit the results to both the FDA and EMA for regulatory approval.
The PDS would seem to have the challenge of duration sorted – what’s needed now is a therapy with superior efficacy to Lucentis.
Excellent news, I think, for Opthea.
https://www.gene.com/media/press-releases/14854/2020-05-26/port-delivery-system-with-ranibizumab-sh
https://clinicaltrials.gov/ct2/show/NCT03677934?term=archway&rank=1
https://www.fightingblindness.org/r...rimary-endpoint-in-phase-3-clinical-trial-126
Genentech success
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