David F. Muller
Avedro, a global leader in corneal biomechanics research, is poised to
assume a significant portion of the fledgling corneal cross-linking market, a
company official said.
The company also expects to create a lucrative new global market niche
with its KXL accelerated cross-linking system, designed to allow cross-linking
to be seamlessly integrated into the standard LASIK procedure, David F. Muller,
PhD, president and CEO of Avedro, said at the Ophthalmology Innovation Summit
in Orlando, Fla.
Avedro has a wide sales and marketing presence built on research and
innovation, Dr. Muller said.
Were fully commercialized around the world, he said.
Were in 41 countries. We have the next generation products that
incorporate a lot of [intellectual property], a lot of new technology.
Theres really nobody thats competitive with us in this basic
The company has 22 ophthalmic device distributors in 41 countries and is
selling its cross-linking system in Canada, Mexico, South America, Europe, the
Middle East, China, Japan, Australia and New Zealand, Dr. Muller said.
Avedros proprietary cross-linking system comprises VibeX, an
ophthalmic riboflavin formulation, and the high-energy KXL device that
generates UV light.
Avedro has completed a phase 3 multicenter clinical trial and plans to
submit a new drug application to the U.S. Food and Drug Administration in the
first quarter of 2012, Dr. Muller said.
The clinical trials included one group of patients with keratoconus and
another group with corneal ectasia.
In the keratoconus trial, 102 patients underwent cross-linking and 103
patients served as controls. In the ectasia trial, 91 patients underwent
cross-linking and 88 patients served as controls.
Both active groups of treated patients saw a statistically significant
difference in mean change in maximum corneal curvature, as measure by K-max,
from baseline to 12 months as compared with the control group (both P
In the FDA study, what we were able to show was that the
cross-linking procedure actually stabilized the cornea and prevented it from
getting worse, Dr. Muller said.
Subsequent clinical trials are in the planning phase.
In addition, Avedro is collaborating with the American College of
Ophthalmic Surgeons on an expanded clinical trial to be conducted at 100 sites
in the U.S., Dr. Muller said.
The benefit for us, obviously, is more data, more safety data and
certainly an added patient benefit that goes along with it, he said.
Avedros Lasik Xtra procedure incorporates cross-linking into
standard LASIK surgery.
After excimer laser ablation of the flap bed, riboflavin is applied to
the flap bed for 60 seconds. The riboflavin is flushed from the bed with
balanced saline solution, and the flap is repositioned. UV light is then shone
onto the cornea for 75 seconds.
We know it restores strength to the cornea, Dr. Muller
The Shinagawa LASIK Center in Japan expects to perform more than 2,000
Lasik Xtra procedures in 2012. The center generates $2,500 per bilateral LASIK
case and an additional $2,000 for each bilateral Lasik Xtra procedure, Dr.
Additionally, cross-linking alone can be used to correct myopia and
astigmatism, Dr. Muller said.
This has ramifications of not only expanding the market
as an obvious adjunct to cataract surgery, where most patients need a little
tune-up at the end, he said. Weve demonstrated 3 D of myopia
correction and 2 D of astigmatism correction, all with simply putting eye drops
on the eye and a little light. So, thats going to be attractive to
Lasik Xtra may generate up to $1 billion annually, and myopia correction
may be a several billion dollars a year opportunity, Dr. Muller said.
by Matt Hasson
- David F. Muller, PhD, can be reached at Avedro, 230 Third Ave.,
Waltham, MA 02451; 781-768-3400; email: firstname.lastname@example.org.
- Disclosure: Dr. Muller is president and CEO of Avedro.