ASCRS Team to
Urinary Drug May Cause Cataract Surgery
The American Society of Cataract
and Refractive Surgery (ASCRS) Executive Committee has formed
the ASCRS Flomax Working Group to further investigate problems
during cataract surgery that may be associated with use of the
drug tamsulosin (Flomax) to facilitate urination. The Working
Group will then provide information that can be used to
develop appropriate recommendations for clinicians and the
Flomax is one of the most effective
and widely prescribed drugs for the treatment of benign
prostatic hypertrophy (BPH), a common condition that affects
men in the same age group as those likely to develop
cataracts. Flomax is in a class of drugs called
alpha-adrenergic blockers. It causes the blood vessels to
relax and expand, so that blood passes through them more
easily. This effect relaxes the muscles in the prostate and
bladder neck, making it easier to urinate.
The team includes David F. Chang,
M.D., a member of the ASCRS Cataract Clinical Committee, and
Samuel Masket, M.D., a member of the ASCRS Executive
Committee. Formation of the Flomax Working Group follows the
issuance of an ASCRS physician advisory concerning
Intraoperative Floppy Iris Syndrome (IFIS) -- a new
small-pupil syndrome described by Drs. Chang and John Campbell
in an article in the January issue of EyeWorld.
In the article, Drs. Chang and
Campbell wrote that their review of the pharmacologic
literature suggests that the same alpha-1A receptor subtype
that dominates in the prostate is also present in the iris
dilator smooth muscle. "We postulate that prolonged
pharmacologic blockade results in loss of normal iris dilator
smooth muscle tone. This deficient tone produces the floppy
iris behavior caused by normal intraocular fluid currents
The authors described the clinical
features of IFIS, based upon more than 30 cases reported in
their paper. In addition to subnormal preoperative pupil
dilation, IFIS is characterized by repeated incisional
prolapse of a billowing, floppy iris, causing progressive
intraoperative miosis that isn't prevented by sphincterotomies
and mechanical pupil stretching. Their retrospective study
documented a higher rate of posterior capsule rupture.
In the article, the authors
recommend that preoperative male patients should be questioned
about Flomax use, particularly if the pupil dilates poorly.
They found that temporarily stopping the medication for 2
weeks often improved, but did not eliminate, the floppy
behavior of the iris, and that in a few cases, IFIS still
occurred in patients who were off Flomax for a year.
The authors also provide
recommendations for maintaining the dilation and stability of
the iris during cataract surgery. "We strongly recommend the
use of iris hooks or an iris expansion ring to maintain an
adequate surgical pupil diameter." They go on to say that
because these devices are difficult to insert without
ensnaring the capsulorhexis, "anticipation of IFIS allows
surgeons to reconsider their usual method of small-pupil
management in favor of self-retaining pupil expansion devices
inserted prior to capsulorhexis initiation."
New Policy Reduces
Eye Injuries in Iraq
Commanders Mandate Use of Protective
Responding to an alarming incidence
of combat-related eye injuries to U.S. troops serving in Iraq,
Army and Marine commanders have launched a strict compliance
program mandating that soldiers wear their protective eyewear
in potentially dangerous situations.
An Army Ranger
wears his Wiley X SG-1 protective eye
Ophthalmology Management has
detailed the high incidence of eye injuries to U.S. troops in
Iraq, primarily caused by blasts from the mortars and roadside
bombs used by the insurgents. We also noted that upgraded
protective eyewear, known as eye armor, has been made
available to all U.S. forces deployed to Iraq and
The compliance effort is beginning
to pay off, says Col. Thomas Ward, M.D., ophthalmology
consultant to the U.S. Surgeon General. Col. Ward recently
told Ophthalmology Management that the percentage of
wounded soldiers in Iraq sustaining some sort of eye damage,
which may have been as high as 15% at one point, has recently
dropped to about 6%.
"The data is very rough, but the
lower figure probably greatly reflects the increased use of
eye protection," said Col. Ward.
In World War II, a conflict in
which most wounds were caused by bullets, only about 2.5% of
wounded U.S. soldiers sustained any form of eye damage.
The recent success of the
protective eyewear compliance program probably stems from two
factors. First, the high rate of eye damage has caused
commanders and soldiers to take eye protection more seriously,
with many commanders using special training programs to drive
home the message. And second, the newer eye armor,
particularly the Wiley X SG-1, has found favor with the
soldiers because of the comfort, protection and appealing look
that the eyewear provides.
Inspire trial falls short.
Inspire Pharmaceuticals said results of a Phase III clinical
study of diquafosol tetrasodium for the treatment of dry eye
didn't achieve its primary endpoint. The 6-week study was a
randomized, double-masked comparison of 2% diquafosol
ophthalmic solution to placebo involving 640 patients at 34
U.S. sites. In the study, diquafosol failed to demonstrate
statistically significant improvement for the primary endpoint
of the incidence of corneal clearing.
Improvement compared with placebo
was achieved for a number of secondary endpoints, including
mean corneal staining, mean conjunctival staining and
Inspire stock dropped more than 40%
to $8.88 a share on Feb. 9, the day this news was
Pfizer to acquire Angiosyn.
Pfizer Inc. said it plans to purchase Angiosyn, Inc., a
privately held California drug development company with
expertise in creating antiangiogenic agents for the treatment
of ophthalmic diseases such as wet AMD. Through its
partnership with Eyetech Pharmaceuticals, Pfizer already has a
stake in Macugen, which was recently approved by the FDA as a
treatment for wet AMD.
The Angiosyn deal is tentatively
valued at $527 million, plus future royalty payments if a drug
is approved. Under the terms of the agreement, Angiosyn will
be merged into a wholly owned subsidiary of Pfizer.
The transaction is expected to
close in the first quarter.
Award for Alimera funding.
Atlanta-based Alimera Sciences Inc., an emerging ophthalmic
pharmaceutical company, said the company was awarded the
Georgia Biomedical Partnership (GBP) inaugural Deal of the
Year award for its 2004 Series A financing of $26.75 million.
The award recognizes transactions,
such as financing and partnering agreements, that
significantly impact the development of Georgia's life
Since its Series A funding, Alimera
has launched and began to market Soothe Emollient (Lubricant)
Eye Drops, the market's first multidose, emollient-based
artificial tear product. This year, Alimera will initiate
development of its prescription pipeline and expand
distribution for its over-the-counter product.
VA Says "No" to
Decision Ends a Year-Long Battle.
The Veterans Health Administration
has issued a new directive (VHA Directive 2004-070) that
specifies that only ophthalmologists will be permitted to
perform therapeutic laser procedures in VA medical facilities.
VHA Directive 2004-045, which provided that optometrists could
perform these procedures under the supervision of an
ophthalmologist, was rescinded.
"Patient safety is paramount," said
Priscilla Arnold, M.D., president of the American Society of
Cataract and Refractive Surgery (ASCRS). "The position of
state and federal regulatory authorities has been to restrict
the performance of surgery to doctors of medicine and doctors
of osteopathic medicine. Specific surgical training is
mandatory for such privileges. Ophthalmic surgery should be
guarded by the same consideration for public safety, and be
performed only by those professionals who have been properly
trained and are licensed to perform surgery."
Anthony Principi, the Secretary of
Veterans Affairs, wrote that the concerns of other
professional medical groups and the inability of the work
group established by the VHA to develop a plan to implement
the directive that would have allowed optometrists to perform
laser eye procedures under the supervision of an
ophthalmologist prompted the new directive.
The new directive also prohibits
optometrists properly licensed by Oklahoma from performing
laser eye surgeries at VA facilities. Oklahoma is the only
state that permits O.D.s to perform therapeutic laser
Principi's comments were contained
in a letter to Rep. John Sullivan (R-OK), the lead sponsor of
the House bill that would have prohibited optometrists from
performing eye surgery in the VA.
A coalition that opposed allowing
O.D.s to perform surgery in VA hospitals was led by the
American Academy of Ophthalmology, and included ASCRS, the
American Medical Association, the American College of
Surgeons, the American Osteopathic Association and the
American Academy of Family Physicians.
Spreading agent approved.
The FDA has approved single-use hyaluronidase injection 150
units/ml (Amphadase) as a spreading agent for use in
ophthalmic procedures. The product is manufactured by
Vision Blue approved. The
FDA has approved trypan blue ophthalmic solution (Vision
Blue). Vision Blue is the first product approved in the United
States for staining the anterior lens capsule during cataract
The use of Vision Blue will enhance
the ability of eye surgeons to remove white cataracts (an
advanced cataract typically seen in countries where medical
care is not widely available) by allowing the ophthalmologist
to see the capsule as it is cut and removed. Clean cuts in the
capsule are known to reduce some of the risks associated with
the surgical removal of a cataract.
The safety and effectiveness of
Vision Blue has also been established in pediatric patients.
No overall differences in safety and/or effectiveness have
been observed between elderly and younger patients.
Adverse reactions from the use of
Vision Blue are generally self-limited and of short duration.
They include discoloration of IOLs and staining of the
posterior lens capsule and the vitreous.
Vision Blue is currently marketed
in 30 countries. D.O.R.C. International of the Netherlands is
AMO donates to tsunami
relief. Advanced Medical Optics (AMO) and its employees
have donated $120,000 to aid victims of the tsunami that
devastated southern Asia in December.
The bulk of the money was given to
the International Response Fund of the American Red Cross. AMO
made an initial contribution of $20,000 to the American Red
Cross, and offered to match donations from its employees
around the world, who contributed a total of $50,000.
Tung named B&L VP.
Bausch & Lomb has named Henry C. Tung, M.D., corporate
vice president, Global Surgical. Dr. Tung, 46, joins B&L
from Boston Scientific Corporation, where he was vice
president, New Business Development. There, Dr. Tung evaluated
healthcare technologies, led multifunctional due diligence
efforts, closed international transactions and developed
relationships with key physicians, executives, entrepreneurs
and industry leaders. He also played a lead role in the
development and execution of the corporate biopharma business