U.S. FDA Rejects Alimera Eye Implant for Third Time

First Posted: Oct 18, 2013 11:15 AM EDT
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The U.S. Food and Drug Administration has reportedly rejected Alimera eye implant for the third time due to various safety concerns regarding the product.

As it's used to treat retinal swelling in patients suffering from diabetes, according to Reuters, the drug Lluvien has been approved by some European regulators. However, the FDA has rejected the product in the United States three times in the past three years.

They've raised concerns regarding the eye implant's safety profile as of Friday for selling the medical device in the United States.

Diabetes patients must regularly visit the eye doctor for exams in order to avoid eye problems as high glucose levels can increase the risk of eye problems. In fact, diabetes is the leading cause of blindness in adults age 20 to 74.

Cataracts, a clouding or fogging of the normally clear lens of the eye, can be typical in those with diabetes, and many seem to be getting them at an early age, according to Web Md.

Glaucoma may also present a problem for diabetes patients, in which fluid inside the eye does not drain properly and can lead to excess pressure inside. The increase in pressure can damage nerves and blood pressure inside the eye and cause significant changes in vision.

As long as patients follow up with their doctors, treatments can help correct these and other problems, as well as possible surgeries. 

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