At Press Time
Galveston Practice Recovers from Ike
Two Satellite Offices Are Largely Spared.
By Jerry Helzner, Senior Editor
■ Joni Schirmer, the longtime practice administrator at The Eye Clinic of Texas, has had a great deal of experience in preparing for hurricanes. Some of the storms have been big, most have been small and many of the threats never materialized at all. However, she says she learns something new each time.
"This time, I recognized that we shouldn't have left our computer servers in our main office in Galveston," she says. "We had all of our records backed up offsite, but the cost and time to retrieve them all from the back-up company would have been prohibitive. Fortunately, I was able to get to the Galveston office 3 days after the storm and take out the servers, which were undamaged. This is the big lesson that Ike has taught me."
The Eye Clinic of Texas is a relatively large practice, headed by Bernard Milstein, M.D., a much-honored Galveston ophthalmologist. The practice has six doctors and 27 staff, located in three offices.
There was significant water damage at the Galveston office.
"The Galveston office lost its roof and sustained much water damage," says Schirmer. "Our League City and Texas City satellite offices were somewhat out of the main path of the storm, so they escaped with almost no damage, although we had looting in our Texas City office. It was clear that the looters were looking for drugs, but they also took a laptop computer. There were no important records on that computer, so it was just a loss of the hardware."
Schirmer says that the partners closed the practice at noon on Sept. 11, with the storm surge scheduled to hit Galveston the next day.
"Everyone on the staff has a cell phone and most of us can text, which turned out to be a big advantage during the storm," notes Schirmer. "Sometimes, we were able to text when we couldn't communicate by voice."
The practice has already hired a contractor to repair the damage to the Galveston office and is hoping to reopen that location by the end of the year. Electricity to that office was restored 12 days after Ike hit. Meanwhile, all phone lines were quickly reset to directly reach the Texas City and League City offices.
"We couldn't see patients for a few days but we had one of the satellite offices operating the Wednesday after the storm hit," says Schirmer, "so patient care was fairly continuous."
The practice does not carry business interruption insurance because the premium for the Galveston area is huge. It does have wind and flood coverage.
"We feel that having the three offices gives us a cushion, so it is not likely that all three offices would be down at any one time," says Schirmer.
Schirmer, who herself owns two small businesses in the Galveston area, says that Galveston residents are willing to take the hurricane risks to enjoy the benefits of living on the coast.
"It was a bad one but you just have to pick yourself up, clean up the mess and get back to living your life," she concludes. OM
Canaloplasty Advances With New Approval
Glaucoma Treatment Could Be More Widely Adopted.
■ Glaucoma patients may have a promising new treatment option for the reduction of elevated IOP. Very small, complex catheters can now be inserted into small drainage structures within the eye, enabling glaucoma surgeons to enlarge these compromised outflow passages for the treatment of glaucoma. These microcatheters are measured in microns, or approximately the size of four to five human hairs combined.
iScience Interventional, Menlo Park, Calif., recently received expanded indications for use from the FDA for their microcatheters for specific treatment of primary open-angle glaucoma (POAG).
"We have been using the same surgical procedures for the last 50 years with only small modifications," noted Richard A. Lewis, M.D., past-president of the American Glaucoma Society. "Historically, we have been looking for ways to drain fluid out of the eye by using surgically created holes. A relatively new procedure known as the canaloplasty now rejuvenates the eye's natural system to lower pressure."
This minimally invasive surgical technique uses a 250 μm microcatheter to access the drainage channels and utilizes the eye's natural drainage system to remove fluid from the eye. This interventional procedure has been performed worldwide for more than 3 years.
Supporters of canaloplasty say that, much like its more advanced predecessors in interventional cardiology and interventional neuroradiology, canaloplasty is emerging as a practical alternative to more invasive surgical procedures. It is believed that canaloplasty will have its major appeal with glaucoma specialists who can master the learning curve for this demanding procedure.
Canaloplasty microcatheter and fiber optic illuminator.
"Canaloplasty strengthens ophthalmologists' options for patients with primary open-angle glaucoma," asserts Dr. Lewis. "Ophthalmologists have recognized for decades that the ideal solution to glaucoma would restore or maintain the eye's natural drainage system. The canaloplasty does just that."
Bradford J. Shingleton, M.D., of Ophthalmic Consultants of Boston and associate clinical professor of ophthalmology, Harvard Medical School, added, "The canaloplasty is a procedure that is grounded in high technology and science. Over the past several years, respected researchers in Europe, Canada and the United States have amassed clinical data that support the safety and efficacy of canaloplasty for patients with POAG, as well as the significant reduction of costly medications."
During a 30-minute canaloplasty procedure, the surgeon inserts a microcatheter through a small incision, enlarges the main drainage channel and places a small suture inside the canal to maintain the opening so it can function normally. Once completed successfully, this procedure ideally rejuvenates the native drainage system, thus lowering the pressure in the eye.
IN THE NEWS |
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■ Visian sales increase. STAAR Surgical Company reported that global sales of the Visian ICL phakic lens increased approximately 52% during the third quarter of 2008. Sales in the United States increased approximately 25% over year-ago levels. "An increasing number of patients and physicians are choosing the Visian ICL as an alternative to LASIK, evidenced by our growth rates of 30% during the first quarter, 40% in the second quarter and approximately 52% for the third quarter," said Barry Caldwell, STAAR president and CEO. The Visian ICL has now been implanted in approximately 125,000 eyes worldwide. ■ Durezol now available. Sirion Therapeutics announced that Durezol (difluprednate ophthalmic emulsion) 0.05% is now commercially available to ophthalmologists. Approved by the FDA in June, Durezol is a topical ophthalmic corticosteroid indicated for the treatment of inflammation and pain associated with ocular surgery. Sirion also released results of two phase 3b studies in which treatment was initiated 1 day prior to surgery, an approach to therapy that is most similar to the current standard of care. Sirion reported that Durezol administered both b.i.d. and q.i.d. was significantly more effective than placebo in treating postoperative ocular inflammation and relieving ocular pain/discomfort as early as Day 3/4. At Day 14, 81.3% of the Durezol-treated patients in the q.i.d. group had a clinical response vs. 25.0% of the placebo q.i.d. group, while 74.7% of the Durezol b.i.d. patients had a clinical response vs. 42.5% of patients in the placebo b.i.d. group. ■ Surgical gel approved. Akorn, Inc. said the FDA has approved its Akten Ophthalmic Gel 3.5%, a topical, ocular anesthetic formulation. Akorn says Akten is the first ocular anesthetic approved by the FDA via a New Drug Application in four decades. It will be immediately available. Akten is a unit-dose, preservative-free lidocaine gel product, stored at room temperature and intended to be used in any ocular procedure that requires a topical anesthetic agent. Abu Alam, Ph.D., Akorn's senior vice president of New Business Development stated, "The robust data from the multicenter clinical trial with respect to rapid onset and extended duration of anesthesia will be ideally suited for many ophthalmic procedures in both hospital and office-based surgical settings." ■ Addition to Healon line. Advanced Medical Optics, Inc. (AMO) said the FDA has granted premarket approval for Healon D viscoelastic, a clear dispersive ophthalmic viscosurgical device (OVD) for use as a surgical aid in cataract extraction, IOL implantation, corneal transplant and glaucoma filtration surgery. AMO says Healon D OVD's formula provides exceptional clarity in the surgical field and a high degree of protection of corneal endothelial cells. Due to its low molecular weight, Healon D OVD coats the cornea and remains in place throughout the entire surgical process. Its lower viscosity helps in providing lubrication for IOL insertion systems. ■ LASIK slump hurts AMO. Advanced Medical Optics lowered 2008 revenue guidance to a range of $1.17 billion to $1.20 billion and 2008 adjusted earnings-per-share guidance to a range of $0.70 to $0.80. The company had previously forecasted a 2008 revenue range of $1.22 billion to $1.24 billion and a 2008 adjusted EPS range of $1.00 to $1.15. Compared to the same period 1 year ago, AMO's third-quarter 2008 domestic excimer laser procedures declined about 37% and its domestic femtosecond procedures declined about 12%. Based on AMO's view that U.S. economic conditions will continue to weaken, the company now expects domestic excimer and femtosecond procedures to decline further in the fourth quarter. The company had previously expected its fourth-quarter U.S. excimer procedures to decline in the high 30% range and its U.S. femtosecond procedures to grow. ■ OPKO acquires investigational drug. OPKO Health, Inc. has acquired exclusive worldwide rights from Teva Pharmaceuticals Industries Ltd. to Teva's proprietary formulation of budesonide for the treatment of various inflammatory and allergic conditions of the eye. Teva's proprietary budesonide product is currently marketed in Italy under the trade name Xavin for the treatment of asthma. According to OPKO, budesonide is a corticosteroid that has been used for more than 20 years for the treatment of multiple respiratory indications, including asthma, hay fever and other allergies, with demonstrated safety and efficacy. ■ New B&L IOL approved. Bausch & Lomb announced it has received FDA approval to market the Akreos Advanced Optics Aspheric Lens (model AO60) in the United States. The Akreos AO Lens is a single-piece, foldable acrylic IOL with a unique four-haptic design and aspheric optics designed to be aberration-free. The lens is implanted with Bausch & Lomb's single-use AI-28 inserter, which enables single-handed insertion through an unenlarged standard phaco incision. |