|[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
"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
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.
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
Further information is available at www.presbia.com.
Note: Not Available for Sale in the United States.
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