At Press Time
TLC Vision Files for Bankruptcy
LASIK provider Vision Care Holdings also in Chapter 11.
By Jerry Helzner, Senior Editor
■ Two corporate providers of laser vision correction have filed under the bankruptcy-protection laws in recent weeks.
TLC Vision, the largest corporate provider of laser vision correction services in North America, has filed for Chapter 11 bankruptcy protection after the difficult economic environment led to a drop in procedures and revenue. For a number of years, TLC has featured golf superstar Tiger Woods in its advertising. The company said that relationship continues.
Meanwhile, the South Florida Business Journal reported that Vision Care Holdings, a Lake Worth, Florida-based operator of LASIK surgery centers and eye care outlets, filed for Chapter 11 protection on Jan. 14. The newspaper reported that Vsion Care Holdings at one time had claimed affiliations with eye care businesses in 30 states. No other details were immediately available.
Regarding TLC, in a statement that appeared on its Web site, the company said clinical care for patients will continue without change or interruption and that the company will also continue to honor the TLC Lifetime Commitment.
TLC said that it and a group of its senior secured lenders have agreed on a Chapter 11 plan of reorganization.
“This proceeding will enable us to continue providing our surgeons and eye care professionals with the tools, technologies and services they need to deliver high-quality patient care,” said TLC President and COO Jim Tiffany. “After evaluating a number of strategic alternatives with our board of directors and advisers, we decided that restructuring our debt through court protection was the best way to preserve the value of our business. We expect to emerge swiftly from Chapter 11 with a stronger balance sheet and able to better capitalize on our industry leadership position.”
The bankruptcy filing comes as a bit of a surprise. In releasing the company's third-quarter results on Nov. 16, Mr. Tiffany was quoted as saying that “TLC Vision posted solid operating results during the third quarter of 2009. Our refractive centers procedure volume was down 17% for the quarter, in line with industry metrics, and we continued to reduce costs during the quarter.”
He added that TLC continued “to benefit from strong performances in our nonrefractive businesses as they continue to contribute positive EBITDA and cash flow. Our nonrefractive businesses, which include other surgical procedures and general eye care, accounted for 46% of our total revenue for the third quarter. We continued to see solid growth in both our cataract business and eyecare business.”
Mr. Tiffany concluded that the company's consolidated cash balance at September 30, 2009, was $13.2 million. TLC Vision has been a publicly traded company, but recent events have reduced its stock price to a few pennies per share.
In the News …■ AAO survey ranks eyecare advances. A number of new treatments to combat sight-stealing diseases like macular degeneration and glaucoma became available in the past decade, but which advances do ophthalmologists themselves consider most important?The American Academy of Ophthalmology put the question to its members in a recent online survey. Of 423 respondents, more than half (51.9%) cited anti-VEGF treatments for wet AMD as most significant. Optical coherence tomography was next at 23.9%, followed distantly at 6.6% by prostaglandin/prostamide eye drops for glaucoma. Several other advances — including premium IOLs, the femtosecond laser, gene therapy for Leber's congenital amaurosis and DSAEK — were each cited by about 3% of respondents. The survey was conducted through the Academy's Web-based education system, the ONE (Ophthalmic News and Education) Network. ■ Aspheric Crystalens approved. Bausch & Lomb said it is launching the Crystalens AO, the first aberration-free accommodating IOL with aspheric optics, to cataract surgeons worldwide. The announcement follows the recent FDA approval of this newest Bausch & Lomb surgical product. The Crystalens AO will be added to the Crystalens HD and the Crystalens Five-0 to provide a range of options in the Crystalens lineup. The Crystalens AO has prolate aspheric surfaces and is designed to be free of spherical aberration. It is designed to improve retinal image quality without compromising depth of field, providing greater quality of distance and intermediate vision. ■ Novartis seeks full control of Alcon. In a move that was expected by investment analysts, European pharmaceutical giant Novartis, which already owns approximately 25% of Alcon, has offered to buy all the Alcon shares still outstanding for $39.3 billion. The total deal would involve exercising its existing option to buy 52% of Alcon shares from Nestlé for $28.1 billion ($180 a share) while also acquiring the remaining shares from minority shareholders for $153 a share. The lower price offered for the minority shares is being contested by Alcon's independent directors, who have asked for equal treatment for all shareholders. Full ownership of Alcon would provide additional diversification for Novartis, which has previously successfully partnered with Genentech (Lucentis) and QLT (Visudyne) in the development, approval and marketing of therapies for macular degeneration. Novartis has also indicated that, upon attaining control of Alcon, it will integrate its Ciba Vision contact lens subsidiary into a newly formed eye care division. ■ Alcon to buy Sirion drugs. Alcon will purchase the rights in the United States for two FDA-approved topical eye care products from Sirion Therapeutics, Inc. The products are Durezol, a marketed ophthalmic corticosteroid approved for the treatment of inflammation and pain associated with eye surgery, and Zirgan, a recently approved antiviral for the treatment of acute herpetic keratitis (corneal ulcers). In addition, Alcon also acquired the global rights, excluding Latin America, for Zyclorin, currently in clinical development to treat dry eye and other ocular-surface diseases. ■ Once-daily NSAID. Ista Pharmaceuticals has submitted a supplemental new drug application to the FDA for bromfenac ophthalmic solution, an NSAID dosed once daily as a treatment for ocular inflammation and pain following cataract surgery. Ista currently markets Xibrom (bromfenac ophthalmic solution) 0.09%, which is an eye drop labeled for use twice daily, beginning 24 hours after cataract surgery. If approved, Ista plans to market the once-daily product under the brand name XiDay. ■ CCHIT certification. Both Key Medical Software's KeyChart 4.0.0.0 and Compulink's Advantage/EHR Version 10 have earned designations as premarket conditionally CCHIT Certified 2011 Ambulatory EHRs in the CCHIT Comprehensive certification program. The designation is given by the nonprofit Certification Com mission for Health Information Technology, or CCHIT. State governments and private insurers offering incentives to adopt electronic records often require the CCHIT stamp of approval to obtain those incentives. Currently, no eyecare-specific electronic records system can receive certification from CCHIT because it is not a specialty sanctioned by the group. The vendors who are selling to ophthalmology practices and have CCHIT certification have obtained it through their ambulatory certification; that designation does not address its suitability for clinical practice. ■ QLT acquires glaucoma drug. QLT, Inc. has acquired OT-730, a prodrug of a beta-adrenergic antagonist under investigation for the treatment of glaucoma, from privately held Othera Pharmaceuticals, Inc. and its wholly-owned subsidiary, Othera Holding, Inc. for a one-time payment of $7.5 million in cash. In a phase 1/2 study conducted by Othera, OT-730 was demonstrated to be safe and well tolerated in glaucoma patients who have been topically administered with an eye drop formulation. Additionally, the results of that study suggested that OT-730 may have comparable efficacy to timolol, but without the cardiovascular side effects often associated with that drug. QLT is hopeful that further clinical trials will demonstrate that OT-730 can ultimately find its place in what is currently estimated to be a billion-dollar worldwide market for beta blockers. QLT intends to develop formulations of the drug that may include higher dosages and a sustained-release profile. ■ New slit-lamp light source. IntraVista Medical Systems has received 510K clearance from the FDA for Vivid Light, a high-intensity warm color LED replacement light source that improves visualization in a diagnostic slit-lamp biomicroscope, offering greater contrast and detail with a significant reduction in the heat and UV light generated by tungsten bulbs. IntraVista says the absence of heat from the Vivid Light minimizes drying of the eye during slit-lamp examination, improving patient comfort and compliance. Vivid Light is offered for both AC and DC power supplies and requires no modifications to standard diagnostic slitlamp biomicroscopes. Vivid Light is also available in a strobing model that reduces motion for imaging. ■ Inspire dry eye drug fails in phase 3 trial. In yet another example of the difficulty in obtaining FDA approval for dry eye drugs, Inspire Pharmaceuticals said that its phase 3 clinical trial of Prolacria (diquafosol tetrasodium ophthalmic solution) 2% for the treatment of dry eye did not meet either its primary or secondary endpoint. Both endpoints were measures of corneal staining. Prolacria had previously received two FDA “approvable letters” and the latest six-week, 490-patient trial was conducted after consultation with the FDA. “We have provided the top-line results from this trial to our partner Allergan and we will be conducting a thorough review of the program before determining next steps, if any,” said Christy L. Shaffer, PhD, president and CEO of Inspire. ■ Caveat cornea. A pair of letters from European ophthalmologists warn against possible patient injury arising from the use of consumer products. One letter, in the January 2010 British Journal of Ophthalmology, detailed the results of a small study conducted in Glasgow, Scotland, where doctors examined unit-dose artificial tear dispenser tips under scanning electron microscopy. They found that five of the six vials examined had either ragged or serrated edges, largely due to the tearing action required to open the vials. The authors of the letter “My hours at the free clinic are 5 to 10 p.m. several times a month, determined by the patient demand,” says Dr. Lotano. “Another ophthalmologist, Dr. Bill Hobbs, a solo practitioner, also volunteers at the clinic. Since we began offering eye care, word of mouth has led to a big increase in the number of patients we are seeing.” Dr. Lotano believes that other retired physicians should consider getting involved in humanitarian efforts close to their homes. “We hear so much about ophthalmologists volunteering in third-world countries, but economic conditions in our own country are creating a need for these free clinics right here at home,” he asserts. “I know that being involved with the free clinic has given me a new outlook on life. It's very rewarding. I feel that I can use the years of knowledge and experience I have accumulated to continue to make a worthwhile contribution.” suggested such edges could cause corneal abrasions and could even penetrate the corneal epithelium. The second letter, in the January 2010 Cornea, came from Lucerne, Switzerland, and detailed evidence Swiss doctors found that a contaminated bottle of contact lens solution could be the culprit in a case of Acanthamoeba keratitis observed in their clinic. Protozoan-caused keratitis is among the most serious varieties of the disorder. Responding to alternate theories of contamination, the Swiss physicians do emphasize that further analyses of lens maintenance and cleaning systems need to be conducted. |
Dr. Lotano: Giving Back Close to Home
Providing eye care to the “working poor.”
By Jerry Helzner, Senior Editor
■ After a long and productive career as the founder of Piedmont Eye Centers in Lynchburg, Va., Remo Lotano, MD, retired from everyday practice, underwent coronary bypass surgery and found that being relegated to the sidelines was not consistent with his active and positive personality.
“I was a little down after the bypass surgery,” says Dr. Lotano, who recently turned 76. “But I was also hearing about a lot of patients who could not afford to come to our practice anymore.”
Dr. Lotano says many of his former patients fell into the category of “the working poor,” primarily people with one or more part-time jobs who were not covered by health insurance. “Many of them work part-time in restaurants or the fast-food industry,” he notes. “The economy in our area has been relatively stable, but there have been some big layoffs.”
Fortunately, there is an existing free clinic in Lynchburg — the Free Clinic of Central Virginia — and Dr. Lotano asked if they would like to add eye care to their range of services. Once his offer to volunteer at the free clinic was accepted, Dr. Lotano spent about a year acquiring the donated equipment he would need to begin to care for patients.
Piedmont Eye Centers helped a great deal, both with equipment and volunteer support staff. Dr. Lotano also received donations from Alcon, Allergan, Lombart Instruments and Virginia Ophthalmic Services. However, he still has needs for additional equipment, especially an indirect ophthalmoscope.
“I began seeing patients in August,” says Dr. Lotano. “We have a number of diabetics who were existing patients at the free clinic but who needed treatment for diabetic retinopathy. We have also been seeing patients with glaucoma and cataracts, and also children. Some of them pay what they can.” Patients who require cataract surgery or laser treatments are referred to the Piedmont Eye Centers, where these procedures are often provided at no charge.
COURTESY OF REMO LOTANO, MD
Dr. Lotano examines a patient at the Free Clinic of Central Virginia.
“My hours at the free clinic are 5 to 10 p.m. several times a month, determined by the patient demand,” says Dr. Lotano. “Another ophthalmologist, Dr. Bill Hobbs, a solo practitioner, also volunteers at the clinic. Since we began offering eye care, word of mouth has led to a big increase in the number of patients we are seeing.
” Dr. Lotano believes that other retired physicians should consider getting involved in humanitarian efforts close to their homes. “We hear so much about ophthalmologists volunteering in third-world countries, but economic conditions in our own country are creating a need for these free clinics right here at home,” he asserts. “I know that being involved with the free clinic has given me a new outlook on life. It�s very rewarding. I feel that I can use the years of knowledge and experience I have accumulated to continue to make a worthwhile contribution.”
Research Digest
New & Noteworthy Journal Articles
Compiled by Andrew E. Mathis, PhD, Medical Editor
► Intraocular laser trial. An article by Hungarian surgeons in the December 2009 Journal of Refractive Surgery details the use of intraocular femtosecond laser in phacoemulsification. Their study took two parts: a series of five phaco procedures, including capsulotomy and lens fragmentation, in five ex vivo porcine eyes, and then an in vivo study of nine human eyes.
Results in both the pig and human eyes were very promising. Capsulotomies performed with femtosecond laser were uniformly circular with no measurable differences between the x-and y-axes, and incision accuracy was significantly higher than for manual capsulorhexis. The incisions also had greater elasticity than manual incisions, and phacofragmentation time was reduced by 51%.
In human eyes, capsulotomies were similarly successfully created, with successful lens removal and IOL implantation in all eyes. Adverse effects were limited to mild corneal edema, similar to that seen in regular phaco patients, and 100% of eyes had visual acuity of 20/20 at one month postoperatively.
While the authors of the study submit that more extensive case series are needed, they believe the intraocular femtosecond laser holds great promise for the future of refractive surgeries.
► Subconj antibiotic/steroid combo. Cataract surgeons looking for postop drug regimens that all but eliminate patient non compliance may welcome the publication of a recent study documenting the favorable results of ciprofloxacin/triamcinolone administration using a novel sustained-release subconjunctival delivery system.
In the January 2010 Archives of Ophthalmology, Brazilian researchers report on tests of the combo formulation's bioavailability and infection prophylaxis profile vs. ciprofloxacin alone administered as an eye drop six times daily, in two studies using a total of 233 rabbit eye subjects.
A single dose of the injected agent maintained therapeutic levels for up to 10 days, the researchers found, with efficacy and tolerability results comparable to those of the ciprofloxacin eye drop regimen. The authors propose these early findings could stimulate R&D that ultimately yields novel anterior segment drug delivery methods.
► OCT in glaucoma detection. A group of ophthalmologists from Seoul, South Korea, undertook an OCT study of 100 healthy patients and 74 patients with glaucoma, comparing Carl Zeiss Meditec's Stratus OCT with its Cirrus spectral-domain OCT model and reporting their data in the December 2009 issue of Archives of Ophthalmology
All patients were examined using both OCT models. The team found that, while both OCT models were effective in detecting average retinal nerve fiber layer thickness, the Cirrus displayed statistically significantly higher under the receiver operating characteristic curves in several quadrants in early glaucoma.
The authors of the study suggest that the Cirrus may be superior in early glaucoma detection thanks to its incorporation of higher scan resolution and more accurate data registration. Further, they caution that a longer observation period is needed to determine whether changes on OCT will be observed before patients develop worsening symptoms.
► Time for a filter change. In a report in the December 2009 issue of Ophthalmology, ophthalmologists in Italy and India followed up on a poster presentation from the 2008 meeting of the European Association for Vision and Eye Research on an outbreak of post-phaco endophthalmitis in a hospital in the Tamil Nadu state of India.
Twenty patients who underwent cataract surgery between February and April 2009, developed a strain of gram-negative Pseudomonas aeruginosa endophthalmitis that was resistant to a broad range of traditional and newer antibiotics. Most, however, were susceptible to polymyxin B. The strains isolated from patients' eyes were matched to strains isolated from surgical instruments, from the povidone-iodine solution used in the operating theater and from the air conditioning system.
While the research team was able to determine that the air conditioning system was the primary carrier of the P. aeruginosa infections and that most cases responded to treatment with polymyxin B, they nevertheless concluded that the prognosis for this type of endopthalmitis is poor. Of the 20 patients studied, half developed phthisis or required evisceration within a few weeks. The mere fact that this strain of bacteria was multidrug resistant suggests a difficult time ahead in preventing postoperative endophthalmitis.
► Latest diagnostic tool: ice. A group of Greek physicians discovered that a plain ice pack can be an important tool in differential diagnosis of myasthenic diplopia. In a prospective comparative cohort study in the November 2009 Ophthalmology the ophthalmologists examined 89 patients presenting with recent onset of diplopia and/or blepharoptosis. All patients in the cohort were initially treated with an ice pack applied to both eyes for five minutes, with 36 of the patients later diagnosed with diplopia undergoing an additional five minutes of cooling.
Of the 89 patients examined, 15 patients were eventually diagnosed as myasthenic, with the sensitivity for the detection of the disorder calculated at 76.9% after a five-minute application of an ice pack, compared to 92.3% sensitivity in those patients with blepharoptosis. The authors of the study conclude that, with greater standardization of the ice-pack test, sensitivity in diagnosing myasthenic diplopia may increase.
Retina Roundup
Timely and Important Retina News of Interest to All Ophthalmologists
Compiled by Andrew E. Mathis, PhD, Medical Editor
► Unsafe at any age. While links between smoking, alcohol use and AMD have been established for some time, a new report in the January 2010 American Journal of Ophthalmology not only confirms the links but suggests that it's never too late to quit and prevent vision loss.
Physicians at UCLA conducted a prospective cohort study of nearly 2,000 women enrolled in the school's Study of Osteoporotic Fractures, taking fundus photos of the patients that were then graded for AMD. The overall five-year incidence was 24.1%. A statistically significant relationship between alcohol consumption and AMD was noted, as was an increased risk among women 80 years or older who smoked vs. those who did not.
While the study is confounded to some extent by the fact that information on alcohol and tobacco habits relied on self-reporting, which is inherently unreliable, the authors nevertheless note that their data suggest that, even in patients older than 80, quitting smoking can have a beneficial effect on ocular health, including the possible prevention of AMD development.
► More data on diet, too. Data from the Carotenoids in Age-Related Eye Disease Study (CAREDS) appear in the November 2009 Archives of Ophthalmology. The clinical trial team reported that diets high in certain kinds of fat can contribute to the risk of intermediate AMD, while monounsaturated fats may have a protective effect.
A total of 1,787 women who were participating already in the Women's Health Initiative Observational Study (WHI-OS) were recruited from three of the WHI-OS study sites based on their intake of lutein plus zeaxanthin (either above the 78th percentile or below the 28th percentile). Participants ranged in age from 50 to 79 years old. Their fat intakes were assessed over a five-year period, with fundus photography data gathered over a five-year period seven years after the dietary data were gathered.
The study authors found that intake of omega-6 and omega-3 fatty acids were highly correlated with intermediate AMD, while monounsaturated fat intake was correlated with a lower incidence. Total fat and saturated fatty acid intake were associated with increased prevalence of AMD across the population studied.
These data provide more evidence that a diet high in fat may increase the risk of developing AMD. Interestingly, while omega-3 fatty acids are widely deemed to be healthy, the data in this report suggest otherwise. However, there was a much higher correlation between omega-6 intake and AMD development, suggesting that omega-6 intake may mask potential benefits of omega-3 fatty acids.
► Laser still the standard of care. The Diabetic Retinopathy Clinical Research Network's latest research, appearing in the December 2009 issue of Archives of Ophthalmology, indicates that intravitreal triamcinolone acetonide may slow the progression of diabetic retinopathy. However, due to increased risks of cataract and glaucoma, the group does not recommend using triamcinolone over PRP.
Eight-hundred forty eyes in 693 patients presenting with DME were randomized to treatment with laser or two doses (1 mg and 4 mg) of triamcinolone. Followed up out to two years, the probability of progression of retinopathy was 31% in the PRP group, compared to 29% in the 1-mg group and 21% in the 4-mg group. At the three-year mark, these differences appear to remain constant.
The authors of the report conclude that there is little question that 4-mg triamcinolone injections can reduce the risk of progression of diabetic retinopathy. They argue that continued study of the use of corticosteroid in the treatment of retinopathy is warranted; however, they do not suggest a change in the standard of care because of the side-effect profile of triamcinolone and related steroids. This is linked to their finding of 51% of phakic eyes requiring phacoemulsification during the course of the study, as well as well-reported links between triamcinolone and glaucoma in the medical literature.
► Speaking of PRP… One negative outcome of PRP is the significant discomfort it causes for the patient. A team of retinal physicians in the United Kingdom compared an orally delivered transmucosal form of fentanyl citrate, an opioid agonist said to be 100 times more powerful than morphine, with placebo in 35 patients undergoing panretinal photocoagulation. They reported their results in the November/December 2009 issue of Retina.
The British team administered a 200-μg fentanyl lozenge at either the first or second visit, alternating the dose with placebo in both groups. Patients underwent a session of PRP at each visit and were then asked to use a 100-mm visual analog scale (VAS) pain score and a Likert rating scale to determine levels of discomfort.
Patients receiving placebo reported a VAS nearly double that of patients receiving fentanyl (36.4 vs. 19.2 out of 100, respectively). Furthermore, pain reduction upon onset of action was 8.4 in the group treated with placebo first vs. 24.6 treated with fentanyl first — a difference of nearly 300%. There was also a statistically significant decrease in blood pressure in patients receiving fentanyl, probably due to the drug's anxiolytic effects.
Acknowledging inherent dangers with opiate use, the authors suggest that fentanyl can be an effective pain reliever for PRP patients, but they recommend they be supervised, that their pulses be monitored and that they be advised to remove the lozenge if they experience excessive drowsiness. The authors also recommend a crash cart and naloxone be on hand in case of severe adverse effects. OM
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