Article Date: 4/1/2011

Just a Toy, or a Megawatt Injury Risk?
SUBSPECIALTY NEWS

Just a Toy, or a Megawatt Injury Risk?

Laser pointers causing retina damage.

Samantha Stahl, Assistant Editor

■ A simple Google search for “lasers” will bring up the retail site Wicked Lasers, whose alarming tag line reads, “Lasers So Powerful You Won't Believe They're Legal.” While high-powered pointers may be useful for professionals, in the hands of children the gadget can be a recipe for disaster.

As Web sites like Wicked Lasers don't require any proof of age, young kids can purchase the pointers without parental input. Remaining blissfully unaware of possible dangers, children may misuse the products and be too afraid to speak up about eye injuries, fearing stern safety lectures from parents.

Such was the case for the Lucerne Cantonal Hospital in Switzerland, which saw a 15-year-old boy with a dense subretinal hemorrhage due to a laser pointer. The case was reported in The New England Journal of Medicine last September. While playing with the laser, the beam bounced off of a mirror and hit his eye repeatedly. Though the teen experienced blurred vision immediately, he waited two weeks before telling his parents and seeking medical attention.

Karen Gehrs, MD, and Benjamin Kim, MD, of Winter Haven, FL, also encountered a teenager with a laser pointer-injured retina at their practice, the Center for Retina and Macular Disease.

“The lasers can cause thermal injury, primarily affecting the retinal pigment epithelium and the outer retina,” says Dr. Kim. “Subretinal hemorrhage has also been reported. If there is significant damage to the RPE, then these patients are also at risk for the development of choroidal neovascularization.”

Green laser pointers are potentially more dangerous than red lasers, due to the melanin within the RPE that absorbs more energy at green wavelengths than red, explains Dr. Kim. Xanthophyll also absorbs more energy at shorter wavelengths.

While laser pointer injuries remain uncommon, Dr. Kim believes there could be an increase because of the ease of purchasing lasers on the Internet.

“It's now relatively easy to purchase a 200 mW laser online. All you need is a credit card and a mailing address. Additionally, some lasers may be more powerful than labeled if there has been faulty manufacturing. Some of these lasers come from other countries, where manufacturing and marketing regulations are less strict than in the United States.”

Dr. Kim says he isn't surprised that most retinal injuries due to pointers are in children and young adults. “These lasers are marketed on the Internet as toys to the younger population, who may not fully realize their potential for retinal injury.”

Fellows Forum: A Lively Learning Experience

Dr. “Sandy” Brucker delivers guest lecture.

Carl Awh, MD

■ The eleventh annual Retina Fellows' Forum dodged a weather bullet, as one of the fiercest snowstorms in Chicago's history struck just two days after the meeting ended.

The meeting took place on a midwinter weekend at the Westin River North in Chicago. Seventy North American fellows participated in an educational and social program that has become a much-anticipated fixture of the final year of vitreoretinal training.

As in past years, the fellows spent considerable time in the lecture hall with a panel of volunteer faculty, led by Course Director David Chow, MD, and co-directors Carl Awh, MD and Tarek Hassan, MD. Bob Avery, MD, Phil Ferrone, MD, Jeff Heier, MD, Nancy Holekamp, MD, and Peter Kaiser, MD, completed the faculty.

The meeting began on Friday evening with an AMD symposium and sessions on diagnostic instrumentation and pediatric retina. The “Faculty Debates” pitted the faculty against each other to argue the merits of Avastin vs. Lucentis and the best method of primary retinal detachment repair (pneumatic retinopexy vs. scleral buckle vs. vitrectomy). Topics were assigned to the faculty, who relied upon clinical data, personal experience and (most effectively) humor to defend their positions.

A Friday evening reception and dinner provided the first opportunity for the “graduating class” of 2011 fellows to socialize with their peers, the faculty, and representatives from industry.

Saturday offered a full day of panel-driven discussions on diabetic retinopathy, retinal vascular occlusion, trauma, macular surgery, new devices, ”News You Can Use” and advice on career and lifestyle management. As always, a highlight of the meeting was the Distinguished Guest Lecture, this year delivered by Alexander “Sandy” Brucker, MD, of the University of Pennsylvania School of Medicine. Dr. Brucker entertained and inspired the audience with his talk titled “The Butcher, the Baker and the Candlestick Maker.”

The Fellows Forum faculty from L to R: Jeff Heier, Nancy Holekamp, Tarek Hassan, Bob Avery, Sandy Brucker, David Chow, Peter Kaiser, Carl Awh and Phil Ferrone.

For the eleventh consecutive year, Bausch + Lomb provided essential support as the major sponsor of the Retina Fellows' Forum. Genentech provided a generous educational grant to support the opening AMD symposium. Sixteen additional companies representing a cross-section of devices and services important to vitreoretinal practice provided financial support and presented updates to the group about their businesses.

The prestigious and competitive Bausch + Lomb Retina Fellows' Forum Research award went to Dr. Pradeep Prasad of the Jules Stein Eye Institute for his paper, “Ischemic index for the quantification of retinal non-perfusion in BRVO.” Dr. Prasad will present his paper at the 2011 Annual Meeting of the American Society of Retina Specialists in Boston as a specially recognized lecture.

The meeting concluded with dinner, an informal awards ceremony, and the Sixth Annual Retinal Fellows' Forum Bowling Tournament. Fellows and corporate representatives were divided into teams captained by the faculty. Jeff Heier's team emerged victorious, proving that bowling success (at least at this level) is a random event!

The 12th Annual Retina Fellows Forum will be held in Chicago on Friday, January 27 through Saturday, January 28, 2012.

In addition to Bausch + Lomb and Genentech, corporate support for this year's Retina Fellows' Forum was provided by the following: Alcon, Alimera Sciences, Allergan, Carl Zeiss Meditec, Dutch Ophthalmic, Insight Instruments, Iridex, MedOne Surgical, Neovista, Optos, QLT, Quantel Medical, Synergetics, Thrombogenics, Topcon Medical Laser and Volk Optical.

Retinal Prosthesis Wins CE Mark; US Next?

René Luthe, Senior Associate Editor

■ Second Sight's Argus II Retinal Prosthesis System won approval in the European Economic Area (EEA), the first treatment for retinitis pigmentosa (RP) to do so. With the CE Mark approval, the Argus II will be available later this year at some clinical centers in Europe. More sites in the EEA are planned for the future. Additionally, the company said it is focusing on obtaining insurance coverage for the device and the surgical procedure.

“The system is going to cost about $100,000 (US), plus the surgery and hospital-related expenses,” explains Brian Mech, Second Sight's vice president of Business Development. “We recognize that this is a pretty daunting total, so we are working hard to get some insurance coverage and payment in place in Europe.”

He concedes that building an economic case for reimbursement could take time. “Demonstrating things like reduced number of hospital visits and increased productivity takes years, but we are seeing immediate improvements in quality of life and activities of daily living.”

As for bringing the Argus II to the US market, the device is currently in clinical trials here, with a submission to the FDA for marketing clearance planned for later this year. An estimated 100,000 Americans have been diagnosed with RP, says Mr. Mech. The Argus II treats patients with end-stage RP.

The Argus II works by bypassing the damaged photoreceptors of the RP patient, the company explains. A miniature video camera stored in the patient's glasses captures a scene. The images are sent to a small patient-worn computer where they are processed and transformed into instructions sent back to the glasses by a cable. These instructions are transmitted wirelessly to a receiver in an epiretinal prosthesis (this includes a receiving coil, an electronics case and an electrode array) that is surgically implanted in the eye. The signals are then sent to the electrode array, which stimulate the retina's remaining cells. These transmit the visual information along the optic nerve to the brain.

According to Lyndon da Cruz, MD, PhD, consultant retinal surgeon at Moorfields Eye Hospital in London, “The fact that nearly all [30] patients had a stable, safe and functioning system, and that a majority of patients could recognize large letters, locate the position of objects, and the best could read short words, impressed us beyond our most optimistic expectations.”

Genentech Disputes Key Lucentis Patent

Jerry Helzner, Senior Editor

■ A battle involving large payments of patent royalties is brewing between drug developer Genentech and patent holder PDL BioPharma. At issue is PDL's so-called Queen Patent portfolio that covers humanized antibodies that are a key component in a number of major drugs, including Genentech's Lucentis, Avastin and Herceptin. This cornerstone patent portfolio also covers other pharmaceutical companies' drugs, including Tysabri (Biogen Idec/Elan).

In 2010 alone, Genentech (now a subsidiary of Roche) paid PDL a total of approximately $277 million in Queen Patents royalties on the trio of Avastin, Lucentis and Herceptin as sales of these three drugs continued to increase worldwide. However, in August of last year, Genentech/Roche sent PDL a letter saying it no longer accepted the validity of the Queen Patents in Europe. This was a reversal of Genentech's 2003 position, when the company stated that it did accept the validity of the Queen patents and its obligation to pay royalties to PDL on the patents.

PDL is dependent on the Queen patents for almost all of its revenues. However, PDL has fought back by recently signing agreements with other companies that have incorporated the Queen patents into their products. In those agreements, these companies state that they accept the validity of the Queen patents. Among the companies signing agreements with PDL is Novartis, which co-developed Lucentis with Genentech.

Thus, Roche/Genentech now stands alone in questioning the validity of the Queen patents and is being sued for damages in Nevada by PDL. Roche/Genentech has paid royalties on the Queen patents for 2010 and early 2011 sales but some future payments may be in doubt.

The Queen patents expire in 2014, at which point the royalty payments to PDL will quickly diminish and PDL will have to find new sources of revenue or dissolve the company. RP

IN BRIEF
UK won't pay for Lucentis in DME. The British healthcare cost watchdog National Institute of Health and Clinical Excellence (NICE) has made a preliminary ruling that Lucentis not be reimbursed for the treatment of DME. NICE contends that Lucentis does not provide enough value in the DME indication to justify its high cost. NICE also noted that a large percentage of DME patients require both eyes to be treated. NICE does reimburse Lucentis for the wet AMD indication.
PanOptica funds topical wet AMD drug. PanOptica, Inc., a private biopharmaceutical company focused on licensing and developing innovative ophthalmology therapies, announced it has raised $30 million in a Series A financing. This round was led by venture capitalists SV Life Sciences and Third Rock Ventures.
The financing coincides with the company's successful licensing of exclusive worldwide ophthalmic rights to PAN-90806 by OSI Pharmaceuticals, Inc., a wholly owned subsidiary of Astellas US Holding, Inc. in exchange for upfront cash, equity interest in PanOptica, and potential future milestones and royalties. Financial terms of the agreement have not been disclosed. PAN-90806 is a pharmacologically unique small-molecule selective inhibitor of VEGF that PanOptica says shows potential as a topical treatment for wet AMD.


Retinal Physician, Issue: April 2011