1) A study found that approximately 65% of nuclear cataract progressions are due to environmental factors like vitamin C intake, while 35% are genetic. Johnson & Johnson will discontinue its unilateral pricing policy for contact lenses. 2) A Phase I-II study of Encore Vision's EV06 solution for presbyopia found it was safe and effective, with patients showing improved vision beginning at day 15. 3) The FDA approved Avedro's corneal collagen crosslinking (CXL) system and photoenhancers for treating keratoconus, making CXL available in the US for the first time. Studies showed CXL strengthened the cornea and reduced maximum corneal curvature in patients with progressive ker

1. N e w s R e v i e w
4 REVIEW OF OPTOMETRY MAY 15, 2016
IN THE NEWS
Research published in the March issue of
Ophthalmology shows that approximately
65% of nuclear cataract progressions
are the result of environmental factors.
Chief among those factors appeared
to be the dietary intake of vitamin C,
which, the study says, protects against
progression.Another 35% of progression
was chalked up to genetic factors.
Johnson & Johnson announced that it will
discontinue its Unilateral Pricing Policy
(UPP) setting minimum prices for contact
lenses.This move comes amid sustained
pricing and legal battles that have left
ODs battling discount sellers like 1-800
Contacts and Costco.The AOA publicly
renewed its support of UPP and the
Contact Lens Consumer Health Protection
Act, introduced by Sen. Bill Cassidy
(R-La), suggesting that decisive action is
needed to provide stronger protections
for patients against the alleged risks of
discount sellers.An eye care provider’s
direct involvement in lens prescribing “is
the best way to ensure ocular health and
vision are optimally protected,” said Justin
Bazan, OD, of Park Slope Eye of New York.
“UPP helped encourage ECPs to advance
their contact lens knowledge,” he said,
while also helping safeguard against
commoditization.
A Phase I-II proof-of-concept study of
Encore Vision’s EV06 ophthalmic
solution 1.5% for presbyopia indicates
it is safe and effective to use in human
subjects, the company says. Patients
treated with the drug, which attempts
to reverse the gradual stiffening of
the crystalline lens, displayed DCNVA
improvement beginning at day 15
(p=0.017) that continued to the 90-day
study completion (p=0.005).
V O L . 1 5 3 N O . 5 ■ M A Y 1 5 , 2 0 1 6
C
ollagen crosslinking—a pro-
cedure combining ultraviolet
light and a topical riboflavin
photoenhancer to strengthen col-
lagen bonds in the cornea—now
comes to the US, after FDA clear-
ance of three products from Avedro.
“This approval marks a tremen-
dous milestone for the treatment
of progressive keratoconus,” said
Brian Roberts, Avedro’s chief oper-
ating and financial officer, in a state-
ment. On April 18, the company’s
KXL System and two photoenhanc-
ers, Photrexa and Photrexa Viscous,
were cleared for use.
The first studies of corneal
crosslinking (CXL) in kerato-
conic humans date to 1998, and
CXL treatment for progressive
keratoconus has been available in
Canada and Europe for more than
10 years. This recent FDA ap-
proval stems from Avedro’s NDA
submission, comprised of data
from three prospective, random-
ized, parallel-group, open-label,
placebo-controlled, 12-month trials
performed to assess the safety and
efficacy of Avedro’s products for use
in performing CXL in the eyes of
patients with progressive keratoco-
nus. The crosslinked eyes in these
studies showed increasing improve-
ments in Kmax (maximum corneal
curvature) from month three to
month 12. Treated patients had an
average Kmax reduction of 1.4D
in Study 1 and 1.7D in Study 2 at
month 12, compared with average
increases among untreated eyes of
0.5D in Study 1 and 0.6D in Study
2. The third study that comprised
the Avedro NDA tested safety; no
efficacy endpoints were included.
The most common ocular adverse
reactions were corneal opacity
(haze), punctate keratitis, corneal
striae, corneal epithelial defect, eye
pain, reduced visual acuity and
blurred vision. The studies show
that ulcerative keratitis can occur;
Avedro advises that patients be
monitored for epithelial defects.
Calling it “a landmark event
that will jump-start a new era of
keratoconus management in the
United States,” Clark Chang, OD,
of TLC Laser Eye Centers and a
board member of the International
Keratoconus Academy, expects CXL
to make corneal transplants less
common. “As CXL becomes more
widely available, we could have our
first generation of patients who will
not routinely need keratoplasty or
suffer progressive vision loss.”
By Adrienne Taron, Associate Editor
FDA Approves CXL
For Keratoconus
Avedro’s KXL System uses laser
crosshairs to align its optical head with
the eye in preparation for the procedure.
Photo:ClarkChang,OD
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