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TMCNet:  Presbia Submits Investigational Device Exemption for the Presbia Flexivue Microlens

[November 09, 2012]

Presbia Submits Investigational Device Exemption for the Presbia Flexivue Microlens

IRVINE, Calif. --(Business Wire)--

Presbia, a medical device company and leader in near vision restoration, announced today that it has received a letter from the U.S. Food & Drug Administration (FDA) indicating that it is being actively considered for an Investigational Device Exemption (IDE, G120225) for its revolutionary Presbia Flexivue Microlens, an implantable corneal inlay solution for presbyopia, the age-related loss of near vision.

Presbia also announced that Dr. Robert Maloney, Clinical Professor of Ophthalmology at University of California, Los Angeles and Director of the Maloney Vision Institute in Los Angeles, California, will serve as Medical Monitor for the duration of the Presbia Flexivue Microlens' U.S. IDE study, which is a required part of the medical device approval process.

"Submission of this IDE is a significant milestone for the Presbia Flexivue Microlens," said Zohar Loshitzer, Chief Executive Officer of Presbia. "In addition, we are excited that Dr. Maloney has joined Presbia as Medical Monitor for our FDA approval process. His extensive experience as a leading U.S. refractive surgeon and his expertise in the FDA medical device approval process will be a tremendous asset as we continue to bring our innovative and superior alternative to reading glasses to the millions of people that struggle with the loss of near vision.


Once FDA approval of the IDE is received, Presbia plans to initiate its IDE study that will include patients across the U.S. under the direction of Dr. Maloney.

"The Presbia Flexivue Microlens has been implanted in more than 250 patients around the world since receiving its CE Mark in 2009, which allowed its commercial use across 40 countries in Europe and Latin America," said Dr. Maloney. "In that time, patients have reported exceptionally high satisfaction with the improvement to their near vision and their new-found independence from using reading glasses. I am excited to guide Presbia through the U.S. process of approvals for commercialization through the FDA, and be part of this innovative surgical solution to such a common vision problem."

Dr. Maloney is one of the top rated vision-correction specialists in the U.S., and was one of the first surgeons in North America to perform LASIK surgery as part of the original FDA clinical trials. He has trained more than 700 surgeons in the use of the excimer laser, and he has performed more than 50,000 vision correction surgeries. In addition to receiving numerous awards from organizations including the International Society of Refractive Surgery and the American Academy of Ophthalmology, he has published more than 100 articles, abstracts and reports in professional journals, as well as has delivered more than 200 invited lectures on five continents. Dr. Maloney has served as principal investigator for 15 FDA clinical trials for ophthalmological devices.

ABOUT PRESBIA

Presbia is a leading ophthalmic-device company focused on the development of solutions for presbyopia, the age-related loss of the ability to read or focus on near objects. Chief among these approaches is the Presbia Flexivue Microlens, a 3mm-diameter lens that is implanted in the corneal stroma of the patient's non-dominant eye using femtosecond laser technology. The less than 10-minute procedure requires no general anesthesia, and the patient's visual recovery takes only a couple of days. Since the Presbia Flexivue Microlens solution utilizes standard equipment and requires minimal additional training, the procedure requires no significant capital investment by the surgeon's practice.

Further information is available at www.presbia.com.

Note: Not Available for Sale in the United States.


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