Chugai files in Japan for the ocular implant component of the ranibizumab Port Delivery Platform, aiming to reduce treatment frequency for nAMD and diabetic macular edema.
Written By: Anand Sathappan, BPharm
Reviewed By: Pharmacally Editorial Team
Chugai Pharmaceutical has filed a regulatory application in Japan for the medical device component of the Port Delivery Platform with ranibizumab, an ocular implant designed to provide sustained drug delivery for retinal diseases including neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME).
The submission to Japan’s Ministry of Health, Labour and Welfare (MHLW) covers the implant and its associated ancillary devices. The filing is supported by results from the global Phase III ARCHWAY trial (NCT03677934) in patients with nAMD and the Phase III PAGODA trial (NCT04108156) in patients with DME, both conducted by Roche and Genentech in the United States.
The Port Delivery Platform combines a surgically implanted ocular reservoir with a customized formulation of ranibizumab. Once implanted, the device continuously releases the VEGF inhibitor into the eye, maintaining stable drug concentrations for extended periods. Unlike standard treatment that requires intravitreal injections every four to sixteen weeks, the implant can be refilled through a minimally invasive procedure approximately once every 24 weeks.
Ranibizumab works by inhibiting vascular endothelial growth factor-A (VEGF-A), a key driver of abnormal blood vessel growth and vascular leakage in retinal diseases. These processes contribute to vision loss in both nAMD and DME.
Commercialization of the therapy in Japan will require approval of both the medical device component and the dedicated ranibizumab drug formulation designed for the implant. Chugai plans to file the drug product application in 2026, which will include results from the global ARCHWAY and PAGODA studies as well as data from the domestic Phase I/II TEIEN trial conducted in Japanese patients with nAMD and DME.
If approved, the Port Delivery Platform could offer a long-acting treatment alternative for patients with retinal vascular diseases, potentially reducing the treatment burden associated with frequent clinic visits and repeated eye injections.
Reference
Chugai Files for the Medical Device Component of the Port Delivery Platform with ranibizumab in Japan, 19 March 2026, Mar 19,2026 | Chugai Files for the Medical Device Component of the Port Delivery Platform with ranibizumab in Japan | News | CHUGAI PHARMACEUTICAL CO., LTD.
A Phase III Study to Evaluate the Port Delivery System With Ranibizumab Compared With Monthly Ranibizumab Injections in Participants With Wet Age-Related Macular Degeneration (Archway), ClinicalTrials.gov ID NCT03677934, https://clinicaltrials.gov/study/NCT03677934
A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DME (Pagoda), ClinicalTrials.gov ID NCT04108156, https://clinicaltrials.gov/study/NCT04108156
About the Writer
Anand Sathappan is a pharmacy graduate with interests in pharmaceutical sciences, pharmacology, and medical writing. He also holds certification in medical coding and has familiarity with pharmacology and healthcare documentation. He has completed the Medical Writing Skills for Beginners program offered by the International Medical Writers Association (IMWA). His work focuses on exploring developments in pharmaceuticals and presenting scientific information in a clear and structured manner.