Jennifer A. Webb

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-Linda K. McLoon, PhD, understands why some of her colleagues may be melancholy about the move of the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO) from Fort Lauderdale, FL, where it has convened for 17 years. 

By early April, as many as 189 members had signed a petition asking ARVO leaders to keep the annual meeting in the southern Florida tourist destination. Beginning in 2013, the meeting will convene in various major cities, including Seattle. 

But Dr. McLoon, a member of the ARVO board and its site-selection committee, hopes her colleagues will keep an open mind. After touring eight sites, she feels certain they will like what they see in the new locations, which can accommodate more program options and have a variety of hotel options nearby. 

Organizers say the space at the Greater Fort Lauderdale/Broward County Convention Center simply has become inadequate. Cramped meeting space meant they were limited in the types of programs and opportunities for collaboration they could provide. And without a large, attached hotel, attendees were spread across 32 hotels as far as 50 miles from the convention center. 

"The bottom line is, really, we outgrew the facility," said Lancey Cowan, ARVO's director, meeting logistics. "In program development, there wasn't a lot of flexibility." 

Since ARVO moved its meeting from Sarasota to Fort Lauderdale in 1995, the meeting has grown from some 7,000 attendees to about 12,000 people from all over the world who come to share the latest in vision research and to network with colleagues. About 6,500 abstracts are programmed for this month's meeting, compared with 4,930 in 1995. 

The meeting had so maxed out its space that not one more coffee kiosk could be plugged in without potentially overloading the building's circuits, Dr. McLoon said. 

Accessibility to coffee and wireless Internet service were cited as attendees' two most-desired attributes, she added. 

Even more importantly, the closest hotel, with 589 rooms, is a 10-minute walk away, Cowan said			

Cost is also a concern. Rates at the nearest, most-used hotels run about $250, she said, and those with rates between $99 and $119 have just 10 rooms. 

By contrast, in Seattle, ARVO staff confirmed a $179 rate at a large hotel very close to the convention center. A number of moderately priced hotels are nearby. 

Having attendees staying in close proximity allows more collegiality, organizers said. It also makes it easier for them to come back to their hotel rooms mid-day and return for evening events, Dr. McLoon said. 

"People were spending literally an hour on the shuttle buses trying to get to the meeting," she said. 

Lower-priced hotels also make it possible for research teams and more junior members to attend, Dr. McLoon added. 

Articles

Having the ARVO meeting in any of various locations enables the group to accommodate more program options and have a variety of hotel options nearby.

ARVO moves its annual meeting from Fort Lauderdale

-FDA investigators say counterfeit vials of Roche/Genentech's bevacizumab (Avastin) that have turned up in U.S. medical practices for the second time in 2 months have no active ingredient. 

This time, the 400 mg/16 ml vials are marked Altuzan, the trade name for bevacizumab approved for use in Turkey, and have a lot number B6021. The vials were purchased through foreign sources, including Richards Pharma, alternately known as Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc. 

The FDA has warned 58 oncology practices in 12 states that they should immediately discontinue use of the drug products, including the counterfeit bevacizumab. 

"Although at present ophthalmology clinics have not been alerted, FDA urges the healthcare community to examine their purchasing practices to ensure that they buy directly from the manufacturer or from licensed wholesale drug distributors in the United States," FDA spokeswoman Lisa Kubaska said. 

"FDA reminds healthcare professionals, pharmacies, and wholesalers/distributors that they are valuable partners in protecting consumers from the threat of unsafe or ineffective products that may be stolen, counterfeit, contaminated, or improperly stored and transported. The receipt of suspicious or unsolicited offers from unknown suppliers should be questioned, and extra caution should be taken when considering such offers." 

 Genentench spokesman Terence Hurley referred questions to the FDA. 

In February, the FDA warned that counterfeit versions of bevacizumab, labeled as Avastin with Roche as the manufacturer, were circulating in U.S. medical practices. In that case, 19 oncology practices were warned to stop using the drugs they purchased from Quality Specialty Products, also known as Montana Health Care Solutions, and distributed by Volunteer Distribution in Gainesboro, TN. Those versions also did not contain the active ingredient. 

Kubaska said the counterfeit products were found as part of the agency's ongoing investigations targeting criminal enterprises involved in drug counterfeiting activities. 

In circumstances in which FDA-approved drugs are in short supply, the agency will authorize certain, limited importation of medicines. However, they are obtained from approved international sources and distributed through a controlled network, and would not be sold in direct-to-clinic solicitations, the FDA said. Bevacizumab is not in short supply. 

FDA investigators say counterfeit vials of Roche/Genentech's bevacizumab that have turned up in U.S. medical practices for the second time in 2 months have no active ingredient.

More supplies of counterfeit drug found

-Six years after OSI Pharmaceuticals Inc. bought Eyetech Pharmaceuticals Inc. for $650 million on the promise of its treatment for wet age-related macular degeneration (AMD), Valeant Pharmaceuticals International Inc. has announced it will acquire Eyetech for $22 million. 

The stark difference in price illustrates how rapidly technology is developing to target specific disease areas. 

When it was approved by the FDA in December 2004, Eyetech's pegaptanib sodium injection (Macugen) was hailed as a revolutionary, breakthrough treatment for wet AMD, which robbed patients of their sight and had no other FDA-approved treatment. It was the first in what was then a new class of anti-vascular endothelial growth factor (VEGF) drugs and was said to represent a new era in treatment of wet AMD. It also was the first therapeutic drug delivered by intraocular injection. 

Moreover, clinical evidence has shown ranibizumab and bevacizumab not only halted vision loss but improved it in many patients. 

By late 2006, pegaptanib annual sales had fallen to $50 million, and OSI announced it would sell Eyetech. Within 2 years, sales dropped to $12 million, and in August 2008, former (OSI) Eyetech employees purchased the division from OSI and established Eyetech Inc.  

Laurie Little, vice president of investor relations, Valeant Pharmaceuticals, said the acquisition helps Valeant expand its presence within ophthalmology, building on two products it collected in 2010 with its purchase of Aton Pharma. 

That deal gave Valeant its first ophthalmic products: preservative-free ophthalmic timolol (Timoptic) in Ocudose, for the treatment of glaucoma, and hydroxypropyl cellulose ophthalmic insert (Lacrisert), a dry-eye treatment. Aton had acquired the U.S. marketing rights for the Timoptic product line from Merck in February 2009.  

"Having two [ophthalmology] products on the list is really too small, so [we hope] this new Eyetech acquisition will help beef up that infrastructure," Little said.  

Eyetech President Steven B. Bettis said he would stay on board with the company under Valeant to assist with the transition.  

"There should be no disruption in the level of service to our customers regarding [pegaptanib]," he said. "We look forward to a positive and productive future with Valeant Pharmaceuticals and contributing to the ophthalmology platform." 

Little said Valeant finds the ophthalmology space "attractive and interesting," and its 2008 acquisition of Dow Pharmaceutical Sciences gave Valeant some research and development capabilities in dermatology and ophthalmology. 

She said the company had not decided what aspect of ophthalmology it would target. On Jan. 30, Valeant walked away from an offer it had made to purchase ISTA Pharmaceuticals for $360 million. ISTA's President and Chief Executive Officer Vicente Anido Jr., PhD, said in January the company would solicit bids from other companies and was not able to meet Valeant's deadline for a decision on the offer. 

"We were really hoping to use that franchise as a growth platform," Little said. 

However, ISTA was one of about 20 companies worldwide Valeant was "in discussions with" about possible acquisition, and Valeant was not willing to wait longer for ISTA, she said. Valeant acquired 11 companies in 2011. 

"For us, it's really important to move quickly. We felt we put a pretty compelling offer out there, and we really wanted a conversation," Little said of the ISTA offer. "We prefer friendly acquisitions like the one we did with Eyetech, but sometimes we feel the shareholders should have a chance to weigh in." 

She said it was a business decision, and wished ISTA's board well. 

"They're doing what they think is right," Little said. "And we hope, at the end of the day, someone else will come along and be willing to pay more than we were." Investment analysts are giving Valeant's acquisition of Eyetech mixed reviews. 

Louise Chen, of Collins Stewart, said in a Feb. 13 report that the acquisition was a small deal-with an additional $4 million possible in potential milestones-at only a two-times  sales multiple, compared with what she saidwas an industry average of three-times sales. She advised investors to watch for Valeant to profit from the deal, even though Eyetech only had net revenues of about $15 million. She noted in a Jan. 6 report that Valeant hopes to be a Top 15 global pharma company by the end of 2013. 

"We continue to expect stock price appreciation to be driven by upward earnings revisions and multiple expansion. These upsides could come from strong execution, acquisitions, revenue synergies, and operating leverage," Chen wrote. 

David A. Amsellem, of Piper Jaffray, said the deal was inconsequential for Valeant. 

"They are trying to carve out a bigger presence in the eye-care space. [Pegaptanib], though, is not a widely used product and faces a lot of competition, so [I'm] not sure how that deal advances that goal," he told 

"Maybe they are just trying to send a signal to physicians that they are intent on becoming a more serious player in ophthalmology." 

Six years after OSI Pharmaceuticals Inc. bought Eyetech Pharmaceuticals Inc. for $650 million on the promise of its treatment for wet age-related macular degeneration, Valeant Pharmaceuticals International Inc. has announced it will acquire Eyetech for $22 million.

Valeant acquires Eyetech

-The FDA has cleared for marketing a hand-held spectral-domain ophthalmic imaging system (Envisu, Bioptigen) that opens new doors to ophthalmologists to diagnose eye disease in infants, children, and disabled adults. 

Last month's 510(k) clearance of the device makes it the first optical coherence tomography (OCT) imaging system to be commercially available in the United States for hand-held and pediatric imaging, the company said in a prepared statement. 

The system will allow pediatric ophthalmologists to diagnose retinal disease, examine the nerve fiber layer, and assess the cornea, sclera, and conjunctiva. It also is the first device cleared for imaging under anesthesia, said Eric Buckland, PhD, Bioptigen president and chief executive officer. 

Although OCT has existed for 15 years, pediatric ophthalmologists have not been able to take advantage of the imaging technology because devices required young or disabled patients to sit up to a tabletop device and cooperate with clinicians. 

The FDA has cleared for marketing a hand-held spectral-domain ophthalmic imaging system that opens new doors to ophthalmologists to diagnose eye disease in infants, children, and disabled adults.

Hand-held optical coherence tomography device cleared for marketing

-A record number of ophthalmologists hit the hallways on Capitol Hill last month to urge their legislators to protect Americans' access to eye care and boost funding for eye research. 

More than 350 ophthalmologists-including about 130 ophthalmology residents-attended the annual American Academy of Ophthalmology (AAO) Advocacy Day on April 26. 

For Ravi D. Goel, MD, a cataract and refractive surgeon in Cherry Hill, NJ, the visit with his congressional representatives was a natural extension of his practice as a physician and an opportunity to build on his relationship their staffs. It was Dr. Goel's 10th year to participate in the annual legislative effort. 

With an estimated 32% cut in Medicare physician fees scheduled for Jan. 1, physicians implored their representatives to find an equitable payment plan to replace the faulty sustainable growth rate (SGR) formula. In February, Congress voted to avoid what then was a 27.4% cut by freezing rates while legislator scramble to find an alternate formula. However, the SGR-mandated cut grows in the meantime.  

Cathy G. Cohen, the academy's vice president, governmental relations, said members of Congress are considering a plan by Rep. Allyson Y. Schwartz (D-PA) that would penalize physicians with a 14% cut if they don't transition to an accountable care organization (ACO). Such a penalty, Cohen said, is drastic and "a huge disservice to put that on the table." 

With input from the academy and other medical groups, Schwartz has amended her plan somewhat to allow physicians to escape the cuts if they're participating in all of the federal programs aimed at improving quality, including the Physician Quality Reporting System, electronic health records, e-prescribing, and value-based purchasing, Cohen said. But with a health system designed to transition to ACOs, many questions remain about how specialists fit into a model that favors primary care. 

In addition to the physician-payment issue, ophthalmologists encouraged their representatives to allocate $32 billion for federal fiscal year 2013 funding for the National Institutes of Health, including $730 million for the National Eye Institute. 

Dr. Goel said he sees his lobbying effort to secure that funding as his role in assisting colleagues doing basic-science research. 

"The NEI produces great research that helps my patients," he said. "My role in their research is to make sure they have the funding they need to help my patients." 

Jeff S. Maltzman, MD, a glaucoma specialist in Phoenix and president of the Arizona Ophthalmological Society (AOS), said he understands how intimidating it can be for physicians to talk with legislators, but it's critical for their understanding of how medicine operates. 

"We don't learn this in medical school and residency," Dr. Maltzman said. "It became very clear to me very early on that a lot of what happens at the state and federal level affects very much how we practice and how we provide care to our patients." 

To encourage more physicians to become comfortable talking with their representatives and senators, the AAO began encouraging state societies to sponsor residents' participation in the Advocacy Day. This year, a record 130 residents attended at the expense of state societies and eye programs. Dr. Maltzman said the AOS sponsored two third-year residents at the University of Arizona: Joan Kim, MD, and Ijeoma Asota, MD. 

A record number of ophthalmologists hit the hallways on Capitol Hill last month to urge their legislators to protect Americans' access to eye care and boost funding for eye research.

All eyes on Capitol Hill

-Ophthalmologists should not order routine genetic tests for patients with common disorders like age-related macular degeneration (AMD) until there are specific therapeutic interventions available to treat the disease based on the genetic information, according to a task force of the American Academy of Ophthalmology (AAO).			

The recommendation is part of a five-page set of guidelines issued earlier this year to help physicians weigh the ramifications and potential benefits of identifying genes associated with inherited eye diseases before ordering tests for their patients. The guidelines offer a framework for physicians to discuss the issue with patients. 

While testing can very clearly reveal the cause of a patient's disease in some situations, in others, a detected genetic variation may be only part of the explanation, he said. 

Monogenic disorders, such as retinitis pigmentosa and sickle-cell anemia, are linked to alterations in a single gene and their presence can indicate a high probability of developing the disease. However, many disorders are complex and common, such as AMD and glaucoma, and involve the interaction of variations in a number of different genes. The presence of any one disease-associated variant is not highly predictive of disease development, the guidelines state. 

For example, researchers have identified several genes strongly associated with AMD, but in an individual patient, the presence of variations in one or more of these genes is not as predictive of the development of disease as similar variations would be in genes that cause monogenic disease Dr. Stone said. 

"In 2012, the risk of somebody having vision loss from macular degeneration is correlated much more strongly to what a physician sees in [his or her] retina than it is to anything one would see in [his or her] DNA," he said. And, without preventive treatments tied specifically to one genotype or another, testing a patient is of considerably less value than a comprehensive eye exam, he added. 

"If you're going to recommend AREDS vitamins, Amsler grid monitoring, smoking cessation, and periodic follow-up for everybody who has a significant number of drusen, how will the presence or absence of a specific AMD risk allele affect the treatment of an individual patient?" Dr. Stone asked. 

In addition, genetic risk information can cause some people to worry unnecessarily about their health, or not worry enough because they are falsely assured by negative findings of a test. However, the involvement of skilled counselors makes such negative outcomes much less likely, Stone said. 

Ophthalmologists should not order routine genetic tests for patients with common disorders like age-related macular degeneration until there are specific therapeutic interventions available to treat the disease based on the genetic information.