Roche shows durability of eye disease treatments Vabysmo, Susvimo

18 Jul 2024
www.fiercepharma.com
Roche shows durability of eye disease treatments Vabysmo, Susvimo
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Source: FiercePharma
The FDA has accepted Roche's application for its eye implant Susvimo to treat patients with diabetic retinopathy and diabetic macular edema.
After storming the market with its longer-acting macular degeneration shot Vabysmo, Roche is laying the groundwork to expand the reach of its other eye disease innovation—refillable implant Susvimo.
On Thursday, Roche not only announced that the FDA has accepted its application for Susvimo to treat diabetic retinopathy (DR) and diabetic macular edema (DME), the company also unveiled results that demonstrate Susvimo’s durability against both disorders.
Data from the phase 3 Pavilion (DR) and Pagoda (DME) studies show that Susvimo sustained its efficacy for two years while maintaining its safety profile. Roche’s subsidiary Genentech shared the results Thursday at the American Society of retina Specialists (ASRS) annual meeting in Stockholm, Sweden.
On Wednesday at the ASRS, Genentech also presented results from a Vabysmo study, which showed that after four years of treatment more than 90% of patients had no sign of DME and that nearly 80% were able to extend their dosing intervals to every three to four months.
Vabysmo, which was approved in 2022 to treat wet-age-related macular edema (AMD) and DME, entered the market as a longer-acting competition to Regeneron and Bayer’s Eylea. The original Eylea has a staying power of two months until the companies answered in August 2023 with a high-dose version that can be given up to once every four months.
As for Susvimo, the unique product appears back on track. It was initially approved for AMDAMD in October 2021 but was recalled by the company a year later because of a manufacturing issue. Earlier this month, Roche said that the FDA had signed off on its re-launch.
In the long-term results of the Pavilion study, DR patients—who were refilled with Susvimo every nine months through a span of two years—maintained the progress they showed during their first year of treatment. Additionally, 80% of patients achieved a two-step or greater improvement in the 12-step diabetic retinopathy severity scale (DRSS), the primary tool used to measure the progression of the disorder.
In the long-term results of the Pagoda study, DME patients—who received refills of Susvimo every six months for a span of two years—continued to maintain the improvements seen in their vision through one year, which equated to gaining two more lines on an eye chart. Additionally, 95% of those on Susvimo did not need additional treatment with supplemental injections.
“These efficacy and safety results demonstrate that Susvimo can deliver robust vision outcomes over two years for people with diabetic eye diseases that can cause vision loss,” Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of global product development, said in a release. “If approved by the FDA, Susvimo could bring a new treatment paradigm for diabetic eye diseases.”
A large market awaits if Susvimo can earn its label expansion. In the United States, there are 7.7 million with DR. The disorder can progress into DME, which affects 750,000 in the U.S.
The FDA-accepted application was based on the one-year results of the Pavilion and Pagoda studies.
While uptake of Susvimo was slow during its initial launch, the same can’t be said of Vabysmo, which generated sales of 847 million Swiss francs ($933 million) in the first quarter for a 108% year-over-year increase. Meanwhile, Regeneron tallied worldwide sales of Eylea at $2.25 billion, which was a 1% decline from the first quarter of 2023.
Earlier this month, the FDA gave a thumbs up for Vabysmo to be provided in a prefilled syringe. The nod gives doctors a more convenient, ready-to-use alternative to drawing the medicine from a vial.
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