Chugai Files Regulatory Application in Japan for Ranibizumab Port Delivery Ocular Implant, Phase III Data Supports Chugai’s Device Filing

Chugai Pharmaceutical Co., Ltd. announced that it has submitted a regulatory application to Japan’s Ministry of Health, Labour and Welfare for the medical device portion of the Port Delivery Platform with ranibizumab. The filing covers the ocular implant and its associated ancillary devices designed to enable sustained drug delivery.

The submission is supported by data from two global Phase III clinical trials,  the Archway study in patients with neovascular age-related macular degeneration and the Pagoda study in patients with diabetic macular edema. Both studies were conducted in the United States by Genentech, a member of the Roche Group.

“This therapy aims to bring an entirely new treatment option to patients with nAMD and DME by leveraging an innovative ocular implant. Through a mechanism that releases the medicine at a controlled rate, the ocular implant can maintain stable drug levels in the eye over a long period. Treatment can be continued without replacing the implant, which can be refilled using a minimally invasive procedure. While the current standard of care requires intravitreal injections every 4 to 16 weeks, this new approach only requires a refill-exchange once every 24 weeks, potentially reducing the physical and psychological burden associated with frequent clinic visits and procedures. We will work closely with Roche and remain fully committed to obtaining regulatory approval, with the goal of improving patients’ quality of life through continued innovation in ophthalmology,” said Dr. Osamu Okuda, Chugai’s President and CEO.

Commercialization of the Port Delivery Platform with ranibizumab requires regulatory clearance for both the medical device and the drug formulation specifically designed for the implant. While the current filing focuses on the device component, Chugai plans to submit a separate regulatory application for the customised ranibizumab 100 mg/ml drug product in 2026. That filing is expected to include results from Japan’s domestic Phase I/II TEIEN study, as well as the global Archway and Pagoda trial outcomes.