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ASCRS Team to Investigate Flomax
Urinary Drug May Cause Cataract Surgery Complication.

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 FDA.

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 during surgery."

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 Eyewear.

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 armor.

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 Afghanistan.

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.

IN THE NEWS

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 conjunctival clearing.

Inspire stock dropped more than 40% to $8.88 a share on Feb. 9, the day this news was announced.

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 sciences industry.

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 O.D. Surgery
The 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 procedures.

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.

IN THE NEWS

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 Amphastar Pharmaceuticals.

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 surgery.

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 the manufacturer.

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 strategy.