At Press Time
The Role of IOP in Glaucoma
Global Panel Makes Initial Recommendations.
By Jerry Helzner, Senior Editor
■ Experts from the World Glaucoma Association (WGA) have announced the group's first consensus recommendations on intraocular pressure (IOP), its role in glaucoma and how to best measure and manage IOP.
The panel recognized that elevated IOP is the leading risk factor for glaucoma progression and that accurate measurement of IOP plays a key role in assessing glaucoma risk and disease management. The panel's next goal is to define more clearly the relationship between IOP and the optic nerve to minimize permanent damage.
The consensus panel, which represents 70 of the world's principal glaucoma societies, announced its findings at the World Glaucoma Congress.
"It is vital to define clearly how IOP relates to optic nerve damage to improve patient care and to achieve consistency in glaucoma management across the globe," said Robert N. Weinreb, M.D., chair of the WGA Consensus Committee, director of the Hamilton Glaucoma Center and professor of ophthalmology at the University of California, San Diego. "Our goal is to minimize glaucoma progression to preserve sight and maintain the overall quality of life of our patients."
The consensus report was based on the evaluation of more than two decades of intensive worldwide research, which confirmed that IOP is a primary modifiable risk factor for glaucoma. Lowering IOP has been shown to be the only approach demonstrated to prevent and delay glaucoma progression.
The panel recommended that IOP should be evaluated on an individual basis depending on where the patient is along the glaucoma disease continuum. The target levels for IOP should be defined as the estimated range where the risk of progressive disease is unlikely to affect the patient's quality of life. The panel advised that clinicians should consider the amount of glaucoma damage that has already occurred, the IOP at which the initial optic nerve damage occurred, life expectancy, the status of the fellow eye and family history of glaucoma. The panel also considered ways to measure IOP accurately. In particular, the measurement of central corneal thickness (CCT) was identified as crucial. The time of day, how long people have been awake and contact lens use all affect the precision of measurement of CCT.
The panel also concluded that the management of peak and mean IOP are key factors to improving current standards of care.
"The WGA is working constantly to improve the global management of glaucoma in an effort to prevent what should be unnecessary vision loss," said Ivan Goldberg, WGA president and clinical associate professor of Ophthalmology, University of Sydney, Australia. "The WGA has created the consensus process to achieve better patient care for those with glaucoma, and the panel's report is respected globally."
GIVING BACK: Teamwork Makes a Difference
Dr. Fogg Lays the Groundwork for Successful Missions.
By René Luthe, Senior Associate Editor
■ Teamwork is essential to the eyecare missions organized by the Church of Jesus Christ of Latter Day Saints. The place on that team of Gary Fogg, M.D., is to evaluate the needs of, then offer help to, potential host countries — so far, Vietnam, Albania, Argentina, Nigeria, Ghana and Thailand, among others.
Ophthalmologists in those countries frequently have a hard time believing that sometimes there really is such a thing as getting something for nothing. The "something" that the missions provide is teaching doctors new techniques for dealing with their population's most common ocular problems, as well as providing modern equipment and supplies such as IOLs and sutures. "Doctors in these foreign countries are sensitive about having physicians from the United States come in to 'teach' them," Dr. Fogg says. "However, they are interested in 'consultations' and are badly in need of equipment."
To make these consultations happen, Dr. Fogg and his wife, Cheryl, travel from their home in Fresno, Calif., to an underdeveloped country. By the time they arrive, a retired volunteer Mormon missionary couple, residing in the country for an 18-month stint, has already done much of the legwork. The couple contacts someone in the Ministry of Health who helps identify the vision needs in the country. They also schedule meetings with local ophthalmologists for Dr. Fogg, as well as arrange for lodging, a translator and transportation. The missionary couple will remain in the country after Dr. Fogg and his wife leave. They see that the equipment arrives and gets through customs. They also assist the teaching doctor.
In their role as ambassadors, Dr. Fogg and his wife explore the local ophthalmologist's desire for consultation and what specialty it should cover. They also evaluate their equipment. "They just can't believe there is no 'catch' and they possibly have had a bad experience before by having untrained residents come instead of qualified specialists," Dr. Fogg says, "They also suspect that the mission will want to proselytize for the church. But we don't ask for anything in return."
A group of Nigerian patients resting after undergoing cataract surgery.
PHOTO COURTESY OF GARY FOGG, M.D.
After Dr. Fogg and his wife return home they choose one teaching ophthalmologist from a list of volunteers. "The concept is not to do a large number of surgeries, but to train local doctors on how to use the equipment and do the procedures," says Dr. Fogg. "The doctors we call are very generous in donating their time."
Cataracts are by far the most common problem seen on these trips; furthermore, they are mature, hard cataracts, the kind that mean blindness. "In Africa, blindness is considered a death sentence," Dr. Fogg says, "because people can no longer work to support themselves, or can't defend themselves."
The mission doctors teach subspecialty procedures or small-incision extracapsular extraction. "Phaco is more difficult with this type of cataract," he explains. "However, we don't teach phaco anyway, because it requires expensive equipment that doctors in these poor countries don't have."
When the mission is completed, the visiting doctor donates the equipment. Microscopes are among the pieces most frequently needed. In Romania, Dr. Fogg saw a university hospital's sole microscope, which was used by the doctors and 30 residents. "I looked into the microscope and saw about 50 black dots in the lighted field," Dr. Fogg says. "The dots were caused by broken fiber optics — the microscope had no functioning X-Y capabilities. It would be impossible for me to work under those conditions. The Church sent them a new microscope."
The Church of Jesus Christ of Latter Day Saints conducts 25 eyecare missions per year. "We're part of a team, that's what it really is," Dr. Fogg says. "It begins with a volunteer couple and ends with a doctor going to teach and bring equipment to an underdeveloped country. It's amazing how little they have to work with in these countries."
AMO Withdraws Offer for B&L
B&L Shareholders to Vote on Warburg Pincus Bid.
■ With Advanced Medical Optics (AMO) now out of the bidding to acquire Bausch & Lomb, only one more hurdle remains between private equity firm Warburg Pincus and its effort to acquire B&L for $65 a share, or a total of $3.7 billion.
To complete the acquisition, the Warburg Pincus offer requires the approval by shareholders representing a two-thirds majority of B&L stock. This vote, the results of which will be announced in late September, is not necessarily a mere formality. At least two major B&L institutional shareholders, Sandell Asset Management and HealthCor Management, have publicly stated that the Warburg Pincus bid undervalues the company. They believe that the AMO bid of $75 a share in cash and AMO stock should have been given more consideration.
A large AMO shareholder voiced opposition to the deal.
AMO withdrew its bid after B&L refused to give AMO more time to persuade reluctant AMO shareholders to back its $4.3 billion offer. A large AMO shareholder, ValueAct Capital, had said it could not support AMO's takeover effort because AMO would be taking on too much additional debt following the company's recent acquisitions of VISX and IntraLase. ValueAct also said it believed that AMO's management team would be stretched too thin if faced with the task of integrating such a major acquisition as B&L.
In withdrawing its bid, AMO CEO Jim Mazzo sent a letter to Bausch & Lomb, stating that B&L had accepted an inferior bid and had not granted adequate time for AMO to make its case to shareholders. Bausch & Lomb responded in kind, saying that AMO had plenty of time to make its case but had failed to do so.
Though funding has recently dried up for some pending private equity deals due to an overall tightening of lending policies, it is believed that Warburg Pincus can arrange financing for the B&L acquisition, which is considered relatively small by Wall Street standards.
IN THE NEWS |
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■ B&L acquires OTC dry eye treatment. Bausch & Lomb has acquired Soothe emollient eye drops from Alimera Sciences, a privately held ophthalmic pharmaceutical company. Financial terms were not disclosed. Bausch & Lomb says it will expand upon the Soothe brand's success, establishing a broader line of professionally recommended, over-the-counter products to relieve dry eye symptoms. The company will initially focus on two products, each designed to target a different layer of the tear film. Introduced in 2004, Soothe, now renamed Soothe XP, was the first over-the-counter multi-dose, emollient-based artificial tear product. The Soothe XP formulation re-establishes the eye's protective lipid layer, reducing tear evaporation and sealing in moisture, providing up to 8 hours of relief from dry eye discomfort. |
Omission: The following listing was inadvertently omitted from the July Marketplace feature:
AUTOREFRACTORS
Topcon Medical Systems
■ Topcon offers a full line of autorefractors, including the KR/RM-8800 series autorefractors/keratometers, the KR-8000PA tri-functional auto keratorefractometer and the KR-9000PW quad-functional wavefront analyzer. The new 8800 series features a color-LCD display and provides measurement through pupils as small as 2 mm.
The tri-functional KR-8000PA incorporates an autorefractor, autokeratometer and color corneal mapping all in one unit, while providing corneal mapping measurements out to 10 mm. The KR-9000PW features a full-range autorefractor, autokeratometer and computerized corneal mapping system, as well as a wavefront analyzer. The instrument provides sphere, cylinder and axis measurements as well as indicating spherical aberrations, coma and other higher-order aberrations of the eye. It is based on the most reliable wavefront measurement principles (Hartmann-Shack wavefront sensor and Zernike Polynomials), says Topcon.
All Topcon units feature exclusive integrated rotary-prism technology for accurate measurement results.
Topcon Medical Systems
Phone: (800) 223-1130
www.topconmedical.com
IN THE NEWS |
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■ WaveLight takeover takes turn. Carl Zeiss Meditec (CZM) said it has acquired 5% of the outstanding stock of WaveLight AG and is studying the possibility of making a bid for the company, potentially complicating the friendly takeover of the German-based excimer laser manufacturer by Alcon. Alcon recently received approval from German regulatory authorities to proceed with its offer. WaveLight is best known for developing the Allegretto laser system for use in refractive surgery. The Allegretto laser has a global installed base of more than 800 units. ■ Akorn generic approved. Akorn, Inc. said the FDA has granted approval for OTC sale of its anti-allergen Ketotifen (ketotifen fumarate ophthalmic solution, 0.025%). Ketotifen is the generic equivalent of Novartis' Zaditor ophthalmic solution 0.025%, which was recently granted OTC status by the FDA. The anti-allergen is indicated for up to 12 hours of temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair and dander. Akorn said it expects to launch Ketotifen in October. ■ AzaSite launched. InSite Vision Inc., an ophthalmic therapeutics, diagnostics and drug delivery company, along with marketing partner Inspire Pharmaceuticals, has announced the U.S. launch of AzaSite (azithromycin ophthalmic solution) 1% for the treatment of bacterial conjunctivitis. Inspire's sales force has already begun physician education outreach. InSite Vision developed AzaSite by formulating azithromycin with its patented DuraSite drug delivery vehicle and received approval from the FDA for the treatment of bacterial conjunctivitis in April. In February, Inspire Pharmaceuticals licensed the rights from InSite Vision to commercialize AzaSite in the United States and Canada for ocular infections. ■ New online resource. MedHelp, the oldest and most active online health community connecting people and medical experts online, and the American Academy of Ophthalmology have announced a partnership to bring top eyecare specialists in the field to the Web to personally answer Web site members and visitor questions. Eye doctors and surgeons from AAO's membership will now answer inquiries and provide personalized medical information and advice on http://www.MedHelp.org. ■ Free LRI calculator. Advanced Medical Optics (AMO) has created a free Web site that offers surgeons a simple and effective way to do the preoperative calculations for limbal relaxing incisions (LRIs) using the Donnenfeld LRI technique. Just go to www.lricalculator.com, enter the patient biometry, print out the diagram and make the incision. ■ Eyemaginations expansion. Eyemaginations, a provider of state-of-the-art 3-D education and marketing software for eyecare professionals, has announced its worldwide expansion with the opening of its international headquarters in Erlangen, Germany. OM |