FDA Roundup: New Options for Presbyopia, MS

KAMRA Inlay – Improved Near Vision

The FDA has approved the KAMRA inlay, a device implanted directly into the cornea, for the improvement of near vision in patients with presbyopia who have not had cataract surgery.

Note: Presbyopia describes the inability to change the focusing power of the eye, resulting in impaired near vision.

The inlay works by blocking peripheral light from entering the eye, allowing central light to pass through, improving focus.

The safety and efficacy of the implant were tested in 3 clinical studies. In the main study, 83.5% of 478 participants achieved 20/40 near vision or greater at 12 months.

Common side effects include glare, night vision problems, and blurry vision, as well as corneal complications such as swelling, clouding, and thinning.
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Generic Copaxone – Multiple Sclerosis

The FDA has approved the first generic form of Copaxone (glatiramer acetate injection) for the treatment of patients with relapsing multiple sclerosis (MS).

“Health care professionals and patients can be assured that FDA-approved generic drugs have met the same rigorous standards of quality as the brand-name drug,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Before approving this generic product, given its complexity, we reviewed additional information to make sure that the generic product is as safe and effective as the brand name product.”

The most common side effect of the drug, taken in the form of a 20 mg/1 ml daily injection, were pain at the injection site, flushing, rash, shortness of breath, and chest pain.

FDA Recall – Listeria in Blue Bell Creameries Products

The FDA is currently investigating a possible contamination of Blue Bell Creameries products with Listeria monocytogenes.

Thus far, 10 hospitalizations and 3 deaths have been reported by the CDC, and Blue Bell Creameries of Brenham, Texas, has issued a voluntary recall of all products currently on the market after samples of the company’s half gallons of ice cream produced on March 17 and March 27, 2015, showed the presence of Listeria monocytogenes.

Overall, 3 strains of Listeria monocytogenes  were identified in cases reported in Arizona, Kansas, Oklahoma, and Texas. The 3 deaths all occurred in Kansas.

—Michael Potts

References:

FDA. FDA approves first-of-its-kind corneal implant to improve near vision in certain patients [press release]. April 17, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm443471.htm

FDA. FDA approves first generic Copaxone to treat multiple sclerosis [press release]. April 16, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm443143.htm

FDA. FDA Investigates Listeria monocytogenes in Ice Cream Products from Blue Bell Creameries [press release]. April 21, 2015. http://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm438104.htm