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


(END) Dow Jones Newswires

June 24, 2021 06:36 ET (10:36 GMT)

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