On 19 March 2026, Chugai Pharmaceutical (a Roche subsidiary) announced that it filed a regulatory application with Japan’s Ministry of Health, Labour and Welfare for the medical device component of its Port Delivery Platform with ranibizumab.
The Port Delivery Platform comprises an ocular implant designed for the long-term, continuous release of a drug into the eye (in this case, ranibizumab). The platform includes the implant and an insertion device, as well as ancillary devices (initial fill needle, refill needle, and explant tool).
Chugai’s regulatory application is based on the global Phase III Archway study results in patients with neovascular age-related macular degeneration (nAMD), and the global Phase 3 Pagoda study in patients with diabetic macular oedema (DME), both conducted in the US by Genentech/Roche, using their Susvimo® (ranibizumab).
Chugai’s announcement follows Genentech/Roche’s announcement in February 2025 that the FDA approved a new indication for Genentech’s Susvimo® (ranibizumab, 100 mg/ml injection) for diabetic macular oedema (DME), making it the first and only approved continuous delivery treatment for DME. The approval was based on one-year results from the Phase 3 Pagoda study.
The FDA had first approved Susvimo® in October 2021. However, in October 2022, Genentech launched a voluntary recall after test results showed some implants did not perform to Genentech’s standards. Genentech has since updated the Susvimo® implant and refill needle. DME is the second indication approved for Susvimo®, after the FDA approved its relaunch for nAMD in July 2024.