at press time

Eye Centers of Florida Overcame Charley
After the Hurricane, the Practice Provided Emergency Care.

On Friday, Aug. 13, the southwest Florida communities of Punta Gorda, Port Charlotte, Arcadia and Fort Myers were among the hardest hit by Hurricane Charley.

Eye Centers of Florida (ECOF), a 16-office practice serving southwest Florida, has offices in each of the aforementioned communities and in other hard-hit locations. The practice was literally in the eye of one of the most devastating hurricanes in history.

But ECOF, founded in 1980 by its medical director, David C. Brown, M.D., was well-prepared for such an occurrence.

"We have a manual for dealing with fires and disasters," says Jamie Novell, CEO of ECOF. "The day before the storm, staff members in all of our locations taped exterior windows, closed all window coverings and covered all equipment with plastic bags. In exterior offices, all items were moved away from windows and off the floor. We don't have EMR, but we protected our paper records and backed up all of our computer files and took them off-site."

Eye Centers of Florida had its mobile screening bus out in the community offering emergency eyecare aid.

Meanwhile, patients who had appointments for Aug. 13 were rescheduled for the following week. Satellite offices closed early on Aug. 12 and remained closed on Aug. 13.

When the storm hit on Aug. 13, most of southwest Florida lost power between 2 and 2:30 p.m.

"At that point we were limited to cell phone communication, but even then we couldn't always get a signal because some towers were down." says Novell. "Our main clinic in Fort Myers was able to open on Monday for business as usual with electricity restored."

Also on Monday, managers of all ECOF satellite offices were contacted and damage assessments were made for each location.

"Eight of our offices suffered relatively minor damage, mainly from water and downed trees in parking lots," says Novell. "We did have many employees whose homes were heavily damaged."

By Tuesday, Aug. 16, 11 of the practice's 16 offices were open and able to keep their patient schedules. Three other satellite offices opened a few days later when power was restored.

"We have business interruption insurance, but our losses from Charley were manageable," says Novell. "However, other medical practices in the area had their offices destroyed, so in those cases the insurance will help a great deal."

Having survived the immediate effects of Charley in relatively good shape, ECOF held a brainstorming session to determine what it could do to help the community. Soon, the practice's mobile vision screening bus was on its way to devastated Punta Gorda and Arcadia. Over a period of several days, the team that accompanied the bus cared for more than 120 people needing eyeglass repairs, foreign body removal, medication, contact lenses and new eyeglasses. Cloths, cleaner, eyeglass cases and contact lens solution were given to those who needed them. Some of the individuals that ECOF helped were relief workers from outside the state.

"Because Charlotte County was without electricity, we alerted the community to our relief efforts via public service announcements on several local radio and TV stations," notes Novell." We also took a paid ad in a local newspaper letting people know which of our offices would be open."

While several ophthalmology practices in the area were closed for days, Eye Centers of Florida was ready and able to offer assistance to the communities it serves.

"We certainly don't expect any public recognition, but our employees feel good that we were out there helping people."

Looking back, Novell says that the practice disaster plan worked well overall.

"You always try to think of what you can do better, but we believe we were well-prepared," he concludes. "Communicating with your people is key, and having home phone numbers isn't the answer when lines are down and people are in shelters. Though cell phones may not always work in these situations, we believe they are the best means of maintaining staff communication during this type of crisis."

IN THE NEWS

Expanded Sensar range. Advanced Medical Optics, Inc. (AMO) has launched an extended low-diopter range of its Sensar IOL with OptiEdge. Already available in the +6D to +30D diopter range, the Sensar is now being offered in diopters from -10D to +5.5D, in .5 diopter increments.

"These new lenses are an important tool for surgeons as many more of us consider diopter expansion," said Samuel Masket, M.D. "The overall length of the 13.5-mm low-diopter Sensar better accommodates the larger eyes of the high myope and also prevents decentration."

Restasis TV ads. Allergan has launched the first direct-to-consumer advertising campaign for its chronic dry eye therapy, Restasis. The TV spots and print advertising feature actress Janine Turner, best known for playing Maggie O'Connell on TV's Northern Exposure, and a real life chronic dry eye sufferer and Restasis user. The ads direct viewers to the www.restasis.com Web site.

Medicare Fee Schedule. The proposed 2005 Medicare Physician Fee Schedule includes only a 0.5% update for ophthalmology, despite the expected 1.5% across-the-board increase for all physicians, according to the American Academy of Ophthalmology.

While some ophthalmology codes increased, such as laser treatment for AMD, others decreased due to practice expense refinements initiated by the Centers for Medicare and Medicaid Services. Ophthalmology also lost some of its Professional Liability Relative Value Units to other specialties with much higher medical malpractice costs.

The final 2005 fee schedule is expected to be released sometime in November.

AVR supports Schepens. Advanced Vision Research, Inc. (AVR), the maker of TheraTears brand lubricant eye drops, is now the single largest private benefactor of the The Schepens Eye Research Institute (SERI). To date, AVR has provided more than $1.5 million in royalty payments to SERI as part of the company's agreement with SERI to license the patents developed at the Institute by Jeffrey P. Gilbard, M.D., the founder, CEO and chief scientific officer of AVR.

SERI is the largest independent eye research institute in the United States dedicated to the fight against blinding and painful eye disease.

Othera receives funding. Othera Pharmaceuticals Inc., a privately held ophthalmic pharmaceutical company based in Kennett Square, Pa., has received $13 million in venture capital funding to pursue clinical development of its ophthalmic drug pipeline.

David S. Joseph, Othera's chairman and CEO, said the capital will allow the company to file an Investigational New Drug Application (IND) for its lead drug, OT-551, an antioxidant eyedrop formulation being developed to prevent or delay cataract formulation. The company also believes OT-551 has promise in halting the progression of the dry form of AMD, and is conducting preclinical studies in this area.

Othera is also moving ahead with a potential glaucoma treatment, OT-730, which is currently in preclinical development. OT-730 is a beta-blocker drug in eyedrop form that's designed to provide the same efficacy as current glaucoma therapies, but without the systemic side effects normally associated with this class.

First Phakic IOL Gets FDA OK
The Verisyse Lens is Approved for Myopia from -5D to -20D.

The FDA has approved the Verisyse/Artisan phakic IOL for use in patients with myopia. The lens was steered through clinical trials by Ophtec USA and will be marketed in the United States by Advanced Medical Optics (AMO).

The Verisyse/Artisan is the first phakic IOL to receive FDA approval. The patented iris-clip lens design was introduced by Ophtec in Europe more than 17 years ago and has been implanted in more than 150,000 eyes worldwide. Ophtec BV manufactures and distributes the lens under the trade name Artisan in all markets except North America and Japan.

In 2002, AMO acquired certain distribution rights to the phakic IOL, which it markets under the Verisyse brand. AMO is the exclusive source for the product in North America and Japan.

The FDA-approved product labeling will indicate that the Verisyse lens is suitable for the reduction or elimination of myopia in adults with myopia ranging from -5.0 to -20.0D and in patients aged 21 and over. This is an expansion of the Ophthalmic Devices panel recommendation of a correction range of -9D to -20D. Ophtec USA's Pre-Market Approval (PMA) application had received expedited review status in August 2003.

"AMO is committed to playing a leadership role in the development of the global refractive IOL marketplace," said James V. Mazzo, AMO president and chief executive officer.

AMO is currently coordinating surgeon training and certification for the Verisyse lens in the United States and expects to begin releasing the product to trained surgeons this month. Information about the Verisyse lens and procedure is available at www.visioninfocus.com.

"This technology provides an excellent alternative for surgeons whose myopic patients may not be good candidates for laser surgery and want to eliminate their dependence on glasses or contact lenses," said Jane E. Rady, corporate vice president of strategy and technology for AMO. "The progressive design of the lens and its placement in the eye's anterior chamber provide high levels of safety and stability, and optimal visual outcomes."

Another phakic IOL, the STAAR Surgical ICL, has been recommended by the Ophthalmic Devices Panel for approval, but
hasn't yet received FDA approval.

Panel: Data Supports Macugen Approval
Long-Term Follow-Up is Recommended.

The FDA's Dermatologic and Ophthalmic Drugs Advisory Committee has found pegaptanib sodium (Macugen) to be a safe and efficacious treatment for wet AMD, but would like to see follow-up studies to determine both the long-term systemic effects of this antiangiogenic agent and the appropriate duration of Macugen treatment.

Though the committee didn't take a formal vote on the Eyetech/Pfizer drug during its Aug. 27 review of Macugen, its members unanimously agreed that the 1-year data from two key Phase II/III trials was sufficiently robust to allow approval. The lack of a formal vote is due to Macugen being reviewed as part of the FDA's continuous application Pilot 1 program, which allows specific parts of high-priority applications to be reviewed before all of the reviewable units are submitted to the agency.

Observers familiar with the FDA approval process believe that the committee meeting allows Macugen to remain on track for final approval later this year.

Because Macugen is a vascular endothelial growth factor (VEGF) inhibitor designed to reduce or eliminate unwanted blood vessels in the eye, the committee recommended long-term monitoring of Macugen patients to determine whether the drug could also inhibit the development of collateral blood vessels leading to the heart and increase the risk of symptomatic cardiovascular disease.

Macugen, which is injected into the eye every 6 weeks, has been proven to slow vision loss from all forms of wet AMD but hasn't been able to restore vision. In two studies totaling almost 1,200 patients, after 54 weeks, 70% of those given the recommended Macugen dose lost fewer than 3 lines of vision on an eye chart. About 55% of patients who received placebo injections also lost fewer than 3 lines.