Roche Eye-Treatment Application Accepted
June 24 2021 - 06:48AM
Dow Jones News
By Matt Grossman
Roche Holding AG said Thursday that the U.S. Food and Drug
Administration has accepted an application for priority review of a
treatment for an eye condition.
The Switzerland-based company said the FDA will review its
biologics license application for its port-delivery system with
ranibizumab for the treatment of neovascular age-related macular
degeneration. The device would help people with the disease avoid
the need to frequent eye injections, Roche said. The FDA will
likely make a decision by Oct. 23.
The system is an eye implant that is about the size of a grain
of rice. It delivers ranibizumab over a period of months to improve
vision in people with macular degeneration.
In a Phase 3 trial, more than 98% of patients using the system
were able to go six months without needing additional treatment,
Roche said. Outcomes were similar to those in patients who got
regular injections.
About 20 million people in the world have the form of macular
degeneration that the device is meant to treat, according to
Roche.
Write to Matt Grossman at matt.grossman@wsj.com
(END) Dow Jones Newswires
June 24, 2021 06:36 ET (10:36 GMT)
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