A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular Edema

Summary

This is a multicenter long-term extension study designed to evaluate the long-term safety and tolerability of faricimab administered by intravitreal (IVT) injection at a personalized treatment interval (PTI) to participants who enrolled in and completed one of the two Phase III studies, GR40349 (NCT03622580) or GR40398 (NCT03622593), also referred to as the parent studies.

Timeline

Start

2020-08-05

Primary completion

2023-10-11

Completion

2023-10-11

Outcome

Met primary endpoint

release “new, four-year data from the RHONE-X extension study. The study met all primary endpoints” gene.com ↗

release “RHONE-X extension study.1 The study met all primary endpoints, showing that Vabysmo® (faricimab) was well tolerated in people with diabetic macular edema (DME)” roche.com ↗

Publications

• Results Sheth VS, Schlottmann P, Lai TYY, Abreu F, Chang A, Eter N, Gibson K, Hu AY, Korobelnik JF, Kotak A, Kotecha A, O'Leary OE, Pearce I, Sim DA, Sun JK, Tang Y, Khanani AM. Four-Year Outcomes of Faricimab in Diabetic Macular Edema: Results from the RHONE-X Extension Trial. Ophthalmology. 2026 May;133(5):599-612. doi: 10.1016/j.ophtha.2026.01.001. Epub 2026 Jan 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Faricimab	Monoclonal antibody	—	Intravitreal

Indications