Regeneron’s eye drug given thumbs up by FDA panel

Regeneron's Eye Drug Approved

Regeneron's new drug for an eye disorder called wet macular degeneration was unanimously approved on Friday by a committee of experts of the Food and Drugs Administration.

The panel voted 10-0 and deemed the new drug from Regeneron as safe and effective as treatment for the eye condition commonly seen in the elderly, an FDA spokesperson said.

Age related wet macular degeneration results to a loss of vision in the central portion of the visual field. About 200,000 new cases are diagnosed annually and the condition is considered one of the major causes of visual impairment among seniors.

The panel is recommendatory in nature but the FDA often follows it as basis for eventual approval of drugs. If approved by August 20, the eye drug from Regeneron will compete with Lucentis which is made by Roche.

Regeneron and Bayer plans to market the new drug under the name Eylea which could impact on the $1.5 billion yearly sales of Lucentis. Patients can receive fewer injection, once a month instead of two, if they get Regeneron's drug instead of Lucentis.

Dry macular degeneration is more common than wet macular degeneration and the latter is said to be the more advanced form of the condition. Wet macular degeneration starts from the growth of blood vessels in the eye, which leaks blood, damages the retina and blocking central vision.

Aside from Roche's Lucentis, Regeneron's Eylea will compete with Roche's Avastin which is a cancer drug but also used off-label to treat macular degeneration because it costs far less.

Posted by George Daniels on Thursday June 23 2011, 4:05 AM EST. Ref: AP. All trademarks acknowledged. Filed under Featured News, Health. Comments and Trackbacks closed. Follow responses: RSS 2.0