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 The surgically implantable device Susvimo is intended to treat wet
age-related macular degeneration (wet AMD), a disorder caused by the
leak of fluid or blood from abnormal blood vessels into an area near
the retina called the macula.
The device is designed to continuously deliver a customized version
of the Swiss company's drug ranibizumab, branded as Lucentis, which
is an anti-vascular endothelial growth factor (anti-VEGF) therapy.
Anti-VEGF therapies, the current standard of care for wet AMD, work
against a protein said to play a key role in the disease. They
require patients to receive eye injections as often as monthly to
preserve vision.
Susvimo is intended for those who have previously responded to at
least two anti-VEGF injections and needs to be taken only twice a
year, reducing the treatment burden for patients.
Roche said Susvimo, which includes the implanted device and
medicine, would be priced at $9,250 for the first six months.
Refills are priced at $8,000 for every six months.
More than 98% of patients treated with the device were able to go
six months before needing a refill in the company's late-stage study
last year.
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 "This device will be a
first-of-its-kind alternative to the current
standard of care injections for patients with
wet AMD," Levi Garraway, Roche's chief medical
officer, said in an interview with Reuters
before the approval.
The device has an exchange mechanism that
automatically refills a new batch of medicine
while the residual drug is being removed,
Garraway said.
UBS analyst Michael Leuchten estimates that the
U.S. market size for AMD is roughly $3.5
billion.
Susvimo's approval comes with a warning that the
implant was associated with a three-fold higher
rate of eye infection endophthalmitis than
monthly injections of Lucentis.
(Reporting by Amruta Khandekar and Bhanvi Satija;
Editing by Aditya Soni and Maju Samuel)
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