Log in
E-mail
Password
Show password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
New member
Sign up for FREE
New customer
Discover our services
Settings
Settings
Dynamic quotes 
OFFON
News: Latest News
Latest NewsCompaniesMarketsEconomy & ForexCommoditiesInterest RatesBusiness LeadersFinance Pro.CalendarSectors 
All NewsEconomyCurrencies & ForexEconomic EventsCryptocurrenciesCybersecurityPress Releases

Roche's implant for chronic eye disorder wins U.S. approval

10/22/2021 | 05:41pm EST
FILE PHOTO: Coronavirus disease (COVID-19) outbreak in Lausanne

(Reuters) -Roche Holding AG on Friday won approval from the U.S. health regulator for its eye implant to treat a chronic disorder causing blurred vision, giving patients an alternative to receiving monthly eye injections with existing treatments.

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.

"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)

By Amruta Khandekar and Bhanvi Satija


© Reuters 2021
Stocks mentioned in the article
ChangeLast1st jan.
NOVARTIS AG -1.01% 73.48 Delayed Quote.-12.15%
REGENERON PHARMACEUTICALS 0.70% 637.125 Delayed Quote.31.76%
Latest news "Economy & Forex"
10:16aCanada's TD Bank, CIBC raise dividends as former beats estimates, latter misses
RE
10:15aEU demands Italy enforce penalties for diesel emissions cheating devices
RE
10:10aU.S. labor market tightening; layoffs near three-decade lows
RE
10:08aFactbox-Who will get the Fed regulation job? Here are some of the contenders
RE
10:06aPessimistic on Europe? Try shorting the Swedish crown
RE
09:59aRussia's VK internet group sold to company linked to Putin ally
RE
09:59aGUIDE : How to talk about NFTs at Christmas dinner
09:56aGM extends EV Chevrolet Bolt production halt to late January
RE
09:55aGlobal shares decline on Omicron uncertainty
RE
09:51aGrocery chain Kroger lifts forecast as home cooking stays hot
RE
Latest news "Economy & Forex"