Source:

Press Release

Disclosures: Regillo reports receiving research support from or being a consultant for Adverum, Aldeyra, Allergan, Annexon, Astellis, Aviceda, Chengdu Kanghong, EyePoint, Genentech, Graybug, Iveric, Kodiak, Lineage, Merck, NGM, Notal, Novartis, Ocugen, Opthea, Regeneron, Regenxbio, Stealth, Takeda, Thea and Zeiss.
January 05, 2022
1 min read
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New therapy for wet AMD gains FDA approval

Source:

Press Release

Disclosures: Regillo reports receiving research support from or being a consultant for Adverum, Aldeyra, Allergan, Annexon, Astellis, Aviceda, Chengdu Kanghong, EyePoint, Genentech, Graybug, Iveric, Kodiak, Lineage, Merck, NGM, Notal, Novartis, Ocugen, Opthea, Regeneron, Regenxbio, Stealth, Takeda, Thea and Zeiss.
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Genentech announced the FDA has approved ranibizumab 100 mg/mL injection for wet age-related macular degeneration in patients who previously responded to at least two anti-VEGF injections.

Previously known as the Port Delivery System (PDS) with ranibizumab, the new therapy (Susvimo) is designed for intravitreal use via ocular implant for the treatment of people with wet, or neovascular, AMD.

FDA approved
Source: Adobe Stock

This is the only FDA-approved therapy for wet AMD that offers as few as two treatments per year.

Carl D. Regillo

“Susvimo represents a major advancement in the treatment of retinal disease, and is an important new option for patients with wet AMD,” Ocular Surgery News Editorial Board Member Carl D. Regillo, MD, chief of retina service at Wills Eye Hospital, said in the release. “With Susvimo, my patients now have an option that can help them maintain their vision as well as anti-VEGF injections, but on a more manageable twice-yearly treatment schedule.”

According to the release, Genentech’s newly approved treatment for wet AMD is an alternative to anti-VEGF eye injections, which are needed as often as once per month.

The approval is based on positive results from the ARCHWAY phase 3 study.

As Healio previously reported, the PDS continuously and reproducibly delivered ranibizumab over a period of 6 months or more and eyes treated with the PDS gained an average of 0.2 letters in visual acuity.

According to the release, the new treatment will be available in the U.S. in the coming months.