FDA staff backs Roche's Lucentis for new use

Lucentis didn't just stop vision loss in diabetes patients. It helped them regain sight. That's the conclusion of FDA reviewers, in advance of Thursday's FDA advisory committee meeting, where experts will weigh a new indication for Roche's ($RHHBY) eye drug.

The injectable drug actually improved vision in patients with diabetic macular edema, FDA staff said in their report on the proposed new use. Already approved to treat wet age-related macular degeneration, Lucentis would be the first drug OK'd for diabetic vision loss. That could give it a new edge over a recently approved competitor, Regeneron's ($REGN) Eylea.

As Bloomberg reports, diabetic patients now receive laser therapy for the vision problem. But that treatment approach has limited benefits, Roche's Anthony Adamis, VP of ophthalmology at the Swiss company's Genentech unit, said. "Laser essentially slows the rate of vision loss but very people gain vision," Adamis told Bloomberg. "But what we saw in our trial is people gained vision and significant vision."

FDA reviewers did have questions about the proper dosage. As Reuters reports, the agency staff questioned whether both proposed doses were equally safe and effective.

Until Eylea appeared on the scene, Lucentis was the only drug approved for wet AMD treatment. But the eye drug has faced competition from another anti-VEGF therapy--and fellow Genentech drug. Avastin, the cancer treatment, is often used off-label to treat the eye disease.

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