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Battle of quinolones heats up at ASCRS
As the ASCRS meeting wound down, Alcon received approval for moxifloxacin, the second fourth-generation fluoroquinolone to gain FDA approval.
SAN FRANCISCO – U.S. regulators granted marketing approval for moxifloxacin ophthalmic solution 0.5%, a fluoroquinolone antibiotic, after a 6-month review, Alcon announced here at the end of the American Society of Cataract and Refractive Surgery meeting.
The approval came the Tuesday of ASCRS, the second-to-last day of the meeting, which was the day the exhibit hall closed and clinical sessions were wrapping up.
Vigamox, as the ophthalmic solution will be known, gained approval for use in adults and children as young as 1 year for the treatment of bacterial conjunctivitis. According to an Alcon press release, the solution is highly soluble, allowing it to be formulated at high concentrations.
Clinical trials showed Vigamox to be effective in the treatment of gram-positive bacteria, including Staphylococcus and Streptococcus; it is also highly active against Chlamydia, according to Alcon.
The Food and Drug Administration granted its approval based on data from three clinical trials involving more than 1,400 patients. The antibiotic’s preferred dosing regimen is three times daily for 7 days. Alcon expects to begin shipping Vigamox within the next few weeks.
The approval of Vigamox followed by just over 2 weeks the approval of another fourth-generation fluoroquinolone, Zymar (gatifloxacin ophthalmic solution 0.3%, Allergan).
Following is a wrap-up of some of the other notable business news announced in conjunction with the ASCRS meeting. Some of these items originally appeared on the OSN SuperSite during our daily coverage of the meeting. This is not meant to be an all-inclusive listing of company announcements.
Alcon launches Infiniti
Alcon launched its Infiniti cataract system here at the meeting, in what company officials say “will continue to further” the company in the market.
“What you see here is a culmination of 4 years of development, and a total investment of $40 million,” said Cary Rayment, senior vice president, Alcon United States. “We have worked closely with the ophthalmic community to advance the technology. We are convinced that the Infiniti Vision System will further us in the market.”
Richard J. Mackool, MD, one of the surgeons who developed the technology, described the Infiniti’s threefold capabilities in a presentation at the Alcon booth. He said surgeons can remove a cataract using advanced ultrasound phacoemulsification alone, using a the combination of ultrasound and oscillation provided by the NeoSoniX handpiece, or using the new AquaLase liquefying technology.
“The Infiniti is the n this market,” Dr. Mackool said. “It is the most user-friendly machine I’ve ever seen, and I’ve been removing cataracts for 30 years. This system raises the bar for phacoemulsification.”
AMO cites No. 1 rankings
During a media event held at ASCRS, James V. Mazzo, president and chief executive officer of Advanced Medical Optics, cited several “No. 1” rankings for the company.
Mr. Mazzo said the WhiteStar phacoemulsifier “with cold phaco technology” was ranked No. 1 in market share by a MarketScope study. The OptiEdge IOL has the “first specialized edge designed specifically to reduce and manage PCO and glare,” he said.
He added that the Amadeus microkeratome is No. 1 in 2002 U.S. market share of new sales; the No. 1 preferred microkeratome, according to the Practice Styles and Preferences of U.S. ASCRS Members survey; the No. 1 microkeratome, according to studies conducted by MarketScope and Goldman Sachs; and the No. 1 microkeratome in service, quality and reliability, according to a 2002 MarketScope study.
He added that the Verisyse phakic IOL is the No. 1 phakic IOL, according to a 2002 MarketScope study.
Also during ASCRS, AMO announced the launch of Sovereign Compact phacoemulsification system. According to AMO officials, this device has the same fluidics and power of the Sovereign, including WhiteStar technology, in a portable and lighter package.
AMO grant will fund women’s |
| SAN FRANCISCO — Education and public service were the orders of the day at a recent luncheon here sponsored by the Women in Ophthalmology group. Held during ASCRS, the luncheon brought together women ophthalmologists from all corners of the country to enjoy a sense of camaraderie. Attendees also heard from Brad Wong, executive director of EyeCare America, the public service foundation of the American Academy of Ophthalmology (AAO). This year’s luncheon was sponsored by Advanced Medical Optics. Company president and chief executive officer James V. Mazzo announced at the gathering that AMO will award a yearly grant of $20,000 to Women in Ophthalmology (WIO) to support activities that foster relationships among women in the profession. “This is a thrill for us. Our hope is to make this group bigger and bigger,” Mr. Mazzo said. The grant is intended to fund WIO educational events. As the first AMO-funded speaker, Mr. Wong brought the women up to date on the activities of EyeCare America, which has as its stated mission to prevent avoidable blindness and severe visual impairment by raising awareness, educating and facilitating eye care for the public. The organization’s efforts are global in reach, Mr. Wong said, as evidenced by its programs that send U.S. ophthalmologists abroad to teach and practice, as well as a Rotary Club program that brings doctors from poorer countries here for a 2-week stay. EyeCare America, which was founded in 1980 but assumed its new name only last year, also facilitates education and eye care services for financially disadvantaged people in the United States, particularly senior citizens. Mr. Wong encouraged WIO members to learn more about the organization by visiting the AAO’s San Francisco headquarters. The headquarters also houses the organization’s Museum of Vision. “We would love to have you come down and see what we do. It is because of you that we are there,” Mr. Wong said. For Your Information: |
HRT II macular edema module
A three-dimensional imaging device that provides a new approach to the diagnosis of macular edema will be available soon, according to a speaker here.
Heidelberg Engineering will make available a macular edema module designed to work with its HRT II, John G. Flanagan, PhD, told Ocular Surgery News.
Dr. Flanagan, a professor of ophthalmology at the University of Toronto and a consultant for Heidelberg Engineering, said the most important aspect of the new device is its ability to create a complete 3-D map of the macula.
The module’s 3-D imaging allows physicians to measure diabetic and cystoid macular edema and track the disease’s progression. The HRT II’s software uses the interaction of confocal lasers to gauge retinal thickness.
With the new module, surgeons can see when the amount of scatter increases inside a swollen retina, leading the peak reflectance to decrease and the retinal width to increase.
Limitations of the unit include the fact that signal width measurements are disrupted in the presence of hemorrhage, exudate, retinal lesions, astigmatism and macular pigment, Dr. Flanagan said.
ScienceBased Health AREDS-based product
ScienceBased Health introduced at the meeting its new nutraceutical product, MacularProtect Complete, a formulation that combines high-potency anti-oxidant protection with multinutrient coverage to protect eyesight and overall body health. The product reflects the nutritional profile used in the Age-Related Eye Disease Study (AREDS).
According to Penny Edwards, MPH, CNS, nutrition scientist for ScienceBased Health, the nutraceutical incorporates lutein and zeaxanthin, two carotenoids and a full spectrum of vitamins, minerals, and plant compounds for preserving overall health.
Biosyntrx BioTears clinical trials
Biosyntrx announced the launch of a 10-site clinical trial on its patent-pending systemic treatment for dry eye syndrome, BioTears Oral GelCaps.
According to the company, BioTears is designed to control systemic inflammation associated with dry eye syndrome with a formulation that inhibits arachidonic acid/cyclooxygenase-2 pro-inflammatory prostaglandins and the growth of pathogens in the tear film.
Visx buys Perfect Vision technology
Visx Inc. acquired the WaveScan product line from manufacturer 20/10 Perfect Vision, the company announced here at the meeting. Visx paid $5.9 million for the technology it had previously licensed from the other company. Terms of the agreement allow 20/10 Perfect Vision certain license and distribution rights, the companies stated.
Liz Davila, chairman and chief executive officer of Visx, said “outright ownership of the WaveScan technology is strategically important” to the growth of the company. The technology serves as the basis for the Visx wavefront custom laser device, CustomVue.
CIBA Vision announces deals
CIBA Vision will distribute BioVision’s Centurion SES, a blade-cartridge microkeratome, the company announced here.
According to a CIBA news release, the Centurion SES is designed “with a proprietary cutting system that integrates both the blade and cartridge into one component. It achieves applanation of the cornea through a unique bar applanator.”
The bar design lets the device applanate only the section of the cornea directly in front of the blade. CIBA has secured marketing rights to the device in all countries except Israel, Russia and the Confederation of Independent States. The device is approved for use in the United States; European approval has not yet been granted.
CIBA Vision also announced that it is now a preferred provider of punctum plugs to the Vision Science network of more than 1,500 physicians.
Included in the agreement are CIBA Vision’s punctum plug products in its Tear Saver line, including silicone plugs, Tear Saver Plus Bio-Insulated and collagen punctum plugs. Also included are the company’s punctal gauging system and plug insertion forceps.
CIBA’s Tear Saver punctum plugs feature a tapered shaft design. The silicone plugs range in sizes from 0.4 mm to 0.8 mm. Company documents note the collagen plugs, which dissolve in about 7 to 10 days, are available in lengths of 1.6 mm to 2 mm and sized from 0.2 to 0.4 mm.
Surgeon’s vote: Internal marketing |
| Aggressive promotional marketing tactics are becoming the refractive surgeon’s worst enemy, according to surgeons attending a debate on the issue here. Terrence P. O’Brien, MD, and Jonathan Christenbury, MD, took on the hot topic during a lively Hallway Controversies session, in which the audience voted their choice for the more compelling speaker. According to Dr. O’Brien, excessive promotional external marketing has damaged the image of ophthalmology, trivialized the importance of refractive surgery and lowered the value of the technology and skills involved. Instead of sinking money into advertisements, surgeons should be focused on generating as much positive word-of-mouth as possible, he said. Ideally, this should not cost surgeons a dime. “Internal marketing is a better opportunity for surgeons. It is our friend. Get those patients who have had good results to get out there and tell other people,” Dr. O’Brien said. In defense of external marketing, Dr. Christenbury argued that eye care is a business as well as a profession. Therefore surgeons must seek new ways to communicate their messages to potential clients. “Marketing is nothing more than amplifying word-of-mouth testimonials. The questions we need to deal with are what message are we sending through what media, and how much do we want to spend?” Dr. Christenbury said. External marketing, he said, is “healthier and less expensive for your practice than co-management.” Dr. Christenbury acknowledged the needs to keep marketing strategies informational and to avoid glitzy materials and fraudulent claims. But he urged surgeons to not discount the power of marketing strictly because some in the business may have stretched the ethical boundaries of what is acceptable promotion. “Make sure you know where your dollars are going, so you know your target audience is reached. You have to understand the business of marketing,” he said. At the close of the debate, Dr. O’Brien was awarded the Golden Grizzly Award on behalf of ASCRS and the Refractive Clinical Committee for his ability to convince 66% of the audience that aggressively marketing their practices does more harm than good. |