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A weekly e-journal
by Arthur B. Epstein, OD, FAAO
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6, Number 6 |
Monday,
February 13, 2006 |
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Off
the Cuff: The New FDA
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The past 18 months
have not been easy ones for the FDA. First,
it was the Vioxx and other COX-2 inhibitors
fiasco. Then it was Guidant’s recall of
300,000 implantable defibrillators, followed
more recently by Boston Scientific’s stents.
Clearly, the FDA seemed in trouble. Even the
agency’s associate director of the Office
of Drug Safety, David Graham, was quoted as
saying during congressional testimony that "the
FDA as currently configured is incapable of
protecting America against another Vioxx."
Although I have been quick to criticize the
FDA in the past, I also realize that the agency
has made much progress in addressing its deficiencies.
While I am still not happy that the FDA’s
Dr. Wiley Chambers essentially excludes ODs
from participating in clinical drug trials even
for drugs that we are qualified and licensed
to prescribe, I am pleased that under Dr. Jim
Saviola’s leadership, FDA-mandated post-approval
surveillance put safety in perspective with
silicone hydrogel continuous wear lenses.
The FDA is also pushing the performance envelope
for lenses and lens care products. After years
of 510K "equivalence to a predicate product"
mediocrity, the FDA granted B&L the labeling
phrase "Provides Sustained Comfort, Removes
Protein Daily, Cleans, Rinses, Disinfects and
Stores" for its MoistureLoc product, and
more recently granted even broader labeling--"Reconditions
Lenses to Retain Surface Moisture for Enhanced
Comfort" and "Compatible Disinfection"--to
Alcon for its new RepleniSH MPDS. Rewarding
scientific achievement with labeling claims
may not seem like much, but it is another step
in the right direction for the FDA and for our
patients.
Ocular
Safety of Patients Using Viagra for ED
Sildenafil citrate
(Viagra) improves erectile function in men with
erectile dysfunction (ED) by selectively inhibiting
cyclic guanosine monophosphate (cGMP)-specific
phosphodiesterase type 5 (PDE5), which is present
in all vascular tissue. Sildenafil also has
a weaker inhibitory action on PDE6, located
in the rod and cone photoreceptors. Modest,
transient visual symptoms, typically blue tinge
to vision, increased brightness of lights and
blurry vision, have been reported with sildenafil
use and occur more frequently at higher doses.
Visual function studies in healthy subjects
and in patients with eye disease suggest that
sildenafil does not affect visual acuity, visual
fields and contrast sensitivity. Transient,
mild impairment of color discrimination can
occur around the time of peak plasma levels.
Spontaneous postmarketing reports of visual
adverse events, including non-arteritic anterior
ischemic optic neuropathy (NAION), have been
reported during the seven years that sildenafil
has been prescribed to more than 27 million
men worldwide. However, because men with ED
frequently have vascular risk factors that may
also put them at increased risk for NAION, a
causal relationship is difficult to establish.
No consistent pattern has emerged to suggest
any long-term effect of sildenafil on the retina
or other structures of the eye or on the ocular
circulation.
SOURCE: Laties A, Sharlip
I. Ocular safety in patients using sildenafil
citrate therapy for erectile dysfunction. J
Sex Med 2006;3(1):12-27.
Effect
of Artificial Tears on Visual Field Testing
This
study examined the effect of artificial tear
administration on perimetry of primary open-angle
glaucoma (POAG) patients with dry eye. Forty
patients with POAG experienced in automated
perimetry with symptoms of dry eye were enrolled
in this study. After their pretest visit, they
were instructed to use artificial tears four
times a day in both eyes for one week. After
one week, patients had repeat visual field testing.
Test taking time, reliability parameters (false-positive
and false-negative errors), visual field indices
and number of depressed points at different
probability levels in both total and pattern
deviation plots were compared.
There was significant improvement in reliability
parameters, visual field indices, PSD and SF
in the second testing after artificial tear
administration. Test time significantly increased.
The number of depressed points at all probability
levels also decreased significantly.
Artificial tear administration in glaucomatous
patients with dry eye seems to improve significantly
reliability parameters and visual field indices.
SOURCE: Yenice O, Temel
A, Orum O. The effect of artificial tear administration
on visual field testing in patients with glaucoma
and dry eye. Eye 2006; Jan 27 [Epub ahead of
print].
Early
Age-Related Maculopathy in Eyes After Cataract
Surgery
Patients
aged 60 years and older who had undergone cataract
surgery at Westmead Hospital, Sydney, Australia,
during 2001 to 2003 were examined for age-related
maculopathy (ARM). Interviews using standardized
questionnaires and stereo retinal photography
were performed. Retinal photographs were graded
using the Wisconsin ARM grading system. The
proportions with ARM were compared between surgical
and non-surgical eyes, and between this surgical
cohort and the Blue Mountains Eye Study population.
Of the 622 eligible patients, 454 (73 percent)
were re-examined, with a mean follow-period
of 2.8 years. Surgical eyes had a higher proportion
of early ARM compared to non-surgical eyes and
to the early ARM prevalence found in Blue Mountains
Eye Study participants of similar age.
This study found an increased prevalence of
early ARM in surgical eyes of patients one to
three years after cataract surgery. Whether
this increase in early ARM prevalence leads
to an increased prevalence of late ARM warrants
further investigation.
SOURCE: Pham TQ, Cugati
S, Rochtchina E, et al. Early age-related maculopathy
in eyes after cataract surgery. Eye 2006; Jan
27 [Epub ahead of print].
NEWS
& NOTES
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AMERICAN
PUBLIC HEALTH ASSOCIATION’S
VISION CARE SECTION SEEKS AWARDS
NOMINEES. The Vision Care Section
(VCS) of the American Public Health
Association (APHA) invites nominations
for the Distinguished Service Award,
the Outstanding Scientific Paper/Project
Award and the Outstanding Student
Paper/Project Award. The Distinguished
Service Award, sponsored in part
by a grant from Vistakon, recognizes
an individual, institution or group
that has made an outstanding contribution
or demonstrated continual high quality
service in the area of public health
eye/vision care. The Outstanding
Scientific Paper/Project Award recognizes
an individual, group or institution
that has contributed significantly
to the advancement of eye/vision
care in the public health field.
The VCS-Beta Sigma Kappa Student
Award, sponsored in part by Beta
Sigma Kappa, recognizes a student
or group of students that has contributed
significantly to the advancement
of eye/vision care in the public
health field from the perspective
of a student in optometry, medicine,
public health or related health
professions programs. Awards recipients
will be honored during the annual
APHA meeting in Boston, November
4 to 8, 2006. Nominations are requested
by March 31, 2006, and should include
a narrative statement of up to 250
words and a copy of paper/project
to be considered. Send to: Dr. Satya
B. Verma, Chair, VCS Awards Committee,
Pennsylvania College of Optometry,
8360 Old York Road, Elkins Park,
PA, 19027. For more information,
phone 215-780-1345 or email satya@pco.edu.
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FDA
GRANTS EXPANDED INDICATION OF XIBROM.
The FDA has approved a supplemental
New Drug Application (sNDA) by Ista
Pharmaceuticals, Inc., for expanding
the indications of Xibrom (bromfenac
ophthalmic solution 0.09%) to include the treatment
of pain following cataract surgery.
Xibrom, a topical, twice-daily,
non-steroidal anti-inflammatory
solution (NSAID), was originally
approved by the FDA in March 2005
for treating ocular inflammation
following cataract surgery; Ista
launched Xibrom in the United States
during the second quarter of 2005.
The company acquired U.S. marketing
rights for Xibrom in May 2002, under
a license from Japan’s Senju
Pharmaceuticals Co., Ltd. For more
information, go to www.istavision.com/products/products_xibrom.asp.
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OCUCURE
RECEIVES FUNDING TO DEVELOP NOVEL
AMD THERAPY. OcuCure Therapeutics
has received funding from the Carilion
Biomedical Institute (CBI), an organization
that makes early stage investments
in breakthrough technology, to develop
new proprietary drugs and technologies
to reduce and prevent vision loss
caused by eye diseases. OcuCure
aims to introduce a new group of
differentiated drugs for treating
age-related macular degeneration
(AMD) that have both anti-angiogenic
and angiolytic properties to inhibit
new blood vessels from sprouting
and cause regression of partially
grown blood vessels. Because the
lead compound is a small molecule,
the company believes it is well-suited
for development of a topical eyedrop
dosage. For more information, go
to www.ocucure.com.
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THE BLUE BOOK OF OPTOMETRISTS 2006 Edition
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The
Check Yearly. See Clearly.(SM)
marketing campaign is opening
consumers eyes to the benefits
of regular eye exams. Call
the Vision Council of America
at 800-424-8422 today or visit
checkyearly.com
for your free promotional
materials. |
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Optometric PhysicianTM
Editorial Board
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Chief Medical
Editor
Arthur B. Epstein, OD, FAAO
Editor
Therese
DeAngelis
Art/Production Director
Joe Morris
Project Coordinator
Janice
Miller
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Journal Reviews
Shannon Steinhäuser, OD, FAAO
CIP Team
Alan G. Kabat, OD, FAAO
Joseph Sowka, OD, FAAO
Andrew Gurwood, OD, FAAO
Section Editors
Murray Fingeret, OD, FAAO
William Jones, OD, FAAO
Paul Karpecki, OD, FAAO
Ron Melton, OD, FAAO
Bruce Onofrey, RPh, OD, FAAO
John Schachet, OD, FIOS
Joseph Shovlin, OD, FAAO
Randall Thomas, OD, MPH, FAAO
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