Roche to Reintroduce nAMD Treatment in US After FDA Approves Updates

Following FDA’s approval of a post-approval supplement to its biologics license application, Roche’s Susvimo (ranibizumab) injection treatment for neovascular, or “wet,” age-related macular degeneration (nAMD) will be reintroduced in the United States in the weeks to come, a Roche press release said on July 8, 2024 (1).

The supplement, Roche said, addressed “component-level updates” to the ocular implant and refill needle. A 100 mg/mL dosage of Susvimo was previously approved for intravitreal use via ocular implant for treatment of people with nAMD and will soon be once again available to retina specialists in the US and their patients. Roche voluntarily recalled the ocular implant, insertion tool, and initial fill kit when test results showed some implants did not meet internal standards, which the company said are now satisfied (1).

An advanced form of age-related macular degeneration, “wet” or nAMD is an advanced form of the disease (1). Initially affecting the part of the eye that provides central and sharp vision for reading and similar activities, a progression to nAMD occurs when new, abnormal blood vessels grow uncontrolled under the macula, resulting in swelling and bleeding in many cases, and causing severe and rapid vision loss. Worldwide, approximately 20 million people are living with nAMD, making it the leading cause of vision loss in those over the age of 60.

“We are pleased to reintroduce Susvimo, a unique therapeutic approach shown to provide an effective alternative to regular eye injections by preserving vision with two refills per year in Phase III study patients with neovascular age-related macular degeneration,” said Levi Garraway, MD, PhD, Roche chief medical officer and head of global product development. “Susvimo’s return to the retina community reflects our unwavering commitment to provide innovative retinal treatments and lays the groundwork for future advancements.”

As Garraway described, the Susvimo implant is inserted into the eye surgically in a one-time, outpatient procedure, and the implant is refilled once every six months. In the interim, it provides continuous delivery of a customized formulation of ranibizumab (1). Roche said Susvimo is the only available treatment for nAMD that has been shown to maintain vision with only two refills per year.

FDA originally approved Susvimo for intravitreal use via ocular implant in 2021. Another Roche product, an injection developed by Genentech and known as Lucentis (ranibizumab), was the first treatment approved for the improvement of vision in people with certain retinal conditions, according to the company (1).

In June 2024, Roche announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use gave a positive opinion for extending the marketing authorization of another of its ophthalmology therapies, Vabysmo (faricimab), to include treatment of visual impairment due to macular edema, secondary to retinal vein occlusion, with the European Commission expecting to levy a decision soon after (2).

References

1. F. Hoffmann-La Roche. Roche to Reintroduce Susvimo in the US for People with Neovascular Age-Related Macular Degeneration (nAMD). Press Release. July 8, 2024.
2. Lavery, P. Roche Attains European Recommendation for Retinal Vein Occlusion Treatment. PharmTech.com, June 28, 2024.