At Press Time
Vascular Dysfunction: Sign of Glaucoma?
New research confirms two earlier studies.
By Bill Kekevian, Associate Editor
■ With its reputation as the “sneak thief of sight,” glaucoma can best be treated when diagnosed early, and recently published study results may help physicians do just that. Certain changes to blood vessels in the retina can be an early warning for an increased risk of glaucoma, according to a 10-year study published in the January issue of the journal Ophthalmology.1 These new findings align with the Singapore Malay Eye Study2 and the Beijing Eye Study,3 both of which also supported the theory that vascular dysfunction may be among the pathogenic factors leading to open-angle glaucoma.
The study showed patients with abnormally narrow retinal arteries at the start of the study were about four times more likely to develop open-angle glaucoma after 10 years. The study, which tracked almost 2,500 patients, presented results adjusted for age, family history of glaucoma, smoking, diabetes, hypertension and other factors.
This information could be used to develop an early detection tool, says Paul Mitchell, MD, PhD, of the Centre for Vision Research at the University of Sydney, who led the study.
“Our results suggest that a computer-based imaging tool designed to detect narrowing of the retinal artery caliber or diameter could effectively identify those who are most at risk for open-angle glaucoma,” he says. He warns that “such a tool would also need to account for blood pressure and other factors that can contribute to blood vessel changes.”
The study measured all blood vessels greater than or equal to 25 μm passing completely through a circumferential zone 0.5 to 1 disc diameters from the optic disc margin. Each vessel was identified as an arteriole or a venule by trained graders. In examining the vessel measurements, researchers accounted for blood pressure, diabetes and other factors.
References:
1. Mitchell P, Wong T y, Lee A, et al. Retinal Vessel Caliber Is Associated with the 10-year Incidence of Glaucoma. Ophthalmology. 2013;120:1:84-90
2. Amerasinghe N , Aung T , Cheung N , et al. Evidence of retinal vascular narrowing in glaucomatous eyes in an Asian population. Invest Ophthalmol Vis Sci . 2008;49:5397-5402
3. Wang S , Xu L , Wang Y , et al. Retinal vessel diameter in normal and glaucomatous eyes: the Beijing eye study. Clin Experiment Ophthalmol . 2007;35:800-807
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■ B + L licenses new therapy for ocular redness. Bausch + Lomb has acquired an exclusive global license to a new platform technology that it says may lead to a faster, more effective and longer lasting treatment for ocular redness. The technology employs a different mechanism of action to relieve ocular redness than currently available products, using a uniquely formulated low dose of brimonidine. Licensed from Eye Therapies LLC, a privately held biopharmaceutical company, the technology was developed by Eye Therapies with assistance from Ora, Inc., a private research organization. In a phase 2 study completed in 2012 and conducted by Eye Therapies in collaboration with Ora, Eye Therapies said the new technology appeared effective in reducing ocular redness based on both clinician assessment and patient reporting. The study did not observe the rebound vasoconstriction associated with currently available treatments. Additionally, onset of action was shown to be rapid (within five minutes), with a duration of effect lasting at least four hours. The formulation was found to be safe and well tolerated as dosed in the study, with no reports of serious adverse events. “The new low-dose brimonidine formulation appears to provide greater microvessel constriction at mucosal surfaces and is thought to retain more optimal blood flow from larger feeder vessels,” said Mark B. Abelson, MD, CM, FRCS, senior clinical scientist at Schepens Eye Research Institute. “These are promising indications that this new technology may address some of the issues commonly seen in current therapies.” ■ Sightpath launches mobile femtophaco. Sightpath Medical, a provider of mobile and fixed ophthalmic surgical solutions, is launching its new mobile femtosecond laser for cataract service called MoFe. This new service suite will include a femtosecond laser, an intraoperative wavefront aberrometer and a certified laser engineer, offered on a stop fee and variable cost basis. Sightpath is planning a nationwide roll-out throughout the year. “With our new MoFe service, high capital costs and technology risks are no longer barriers for surgeons to access this new market of femtosecond laser-assisted cataract surgery,” said Jim Tiffany, president and CEO, Sightpath Medical. |
Is QLT Pulling Plug on Punctal Plug?
Company spent $140 million on drug delivery effort.
By Jerry Helzner, Senior Editor
■ After the former management team of QLT Inc. spent approximately $140 million on developing a sustained-release drug-delivery system using specially designed punctal plugs, the company has decided to option the technology to a potential buyer at a fraction of the money already spent.
QLT has entered into an exclusive agreement with Mati Therapeutics Inc., a development company associated with Robert Butchofsky, QLT’s former president and CEO, under which QLT has granted Mati a 90-day option to acquire assets related to QLT’s punctal plug drug-delivery system technology in exchange for $500,000. Mati may extend the option for up to three successive 30-day periods upon payment of an additional $100,000 for each extension.
Should Mati exercise the option, QLT and Mati will enter into an asset purchase agreement and QLT will be entitled to a closing payment of $750,000, certain milestone payments and a low single digit royalty on worldwide net sales of all products using or developed from the technology, according to a news release from QLT.
QLT’s proprietary technology is a minimally invasive system for delivering a variety of drugs to the eye through controlled sustained release to the tear film. The company recently announced that results from two phase 2 clinical studies demonstrated positive trends (with statistically and clinically significant findings) on the efficacy and safety of the Latanoprost Punctal Plug Delivery System in subjects with ocular hypertension and open-angle glaucoma.
Jason M. Aryeh, QLT chairman, stated, “Among the goals the board set for the company in July, the divestiture of QLT’s punctal plug technology was an easily identifiable measure for rationalizing and refocusing the company’s strategy on its synthetic oral retinoid program. Unfortunately, our efforts to recapture value for QLT’s punctal plug delivery system have only yielded a tiny fraction of the nearly $140 million of shareholder capital spent by the former team on the program. Hopefully, Mr. Butchofsky’s extensive experience with and passion for the punctal plug delivery system put him in the best position to realize potential future value from this program, if acquired, and therefore recapture some tangible value from QLT’s ongoing financial interest in the technology.”
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■ Mobius recalls two Mitosol lots. Saint Louis-based Mobius Therapeutics is conducting a voluntary recall of two lots of Mitosol (mitomycin), 0.2 mg/vial, Kit for Ophthalmic Use. The company is taking this action because it cannot exclude the possibility that the affected lots (MO98260 and MO86920) may be non-sterile. These two lots may contain a strain of yeast on one or more parts in the kit and should be considered non-sterile and unsafe for use. Mitosol is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery. Use of these potentially contaminated products could result in serious eye problems and infections, including possible blindness. Mobius has not received any report of adverse events related to this recall. Customers with affected product in their possession should stop using the product immediately and contact Mobius at 1-877-393-6486, Option 2, for safe return of the product. These lots were distributed in the following states: Alabama, Arkansas, Delaware, Georgia, Illinois, Indiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Virginia and Wisconsin between October 22, 2012 and December 14, 2012. Mobius has initiated an investigation to determine the root cause and corrective and preventative actions. ■ Alcon launches Ilevro for cataract surgery pain. Alcon has introduced Ilevro Suspension, a new once-daily treatment for pain and inflammation associated with cataract surgery. In two double masked, randomized clinical trials, Alcon says Ilevro Suspension demonstrated superior clinical efficacy compared to vehicle. In the studies, patients treated with Ilevro were less likely to have ocular pain and measurable signs of inflammation (cells and flare) at the end of treatment than those treated with its vehicle. Patients administered Ilevro experienced superior outcomes when compared to those on vehicle in the following areas: Inflammation resolved at day 14 in 65% of Ilevro patients vs. 32% of patients on vehicle. Pain resolution rates were 86% for patients on Ilevro and 46% for those on vehicle. |
Eye Test Identifies Alzheimer’s Disease
Early-stage, non-invasive scan is accurate in trial.
By Jerry Helzner, Senior Editor
■ Cognoptix said its Sapphire II eye test identified Alzheimer’s disease patients via a beta-amyloid signature in their eyes in a 10-subject proof-of-concept clinical trial. By detecting a specific fluorescent signature of ligand-marked beta-amyloid in the supranucleus region of the human lens, Cognoptix said Sapphire II achieved a twofold differentiation factor between a group of five healthy volunteers and a group of five patients diagnosed with probable Alzheimer’s disease.
“Currently there is no early-stage non-invasive diagnostic for Alzheimer’s disease in the market,” said Paul Hartung, president and CEO of Cognoptix. “Unfortunately, patients often incur up to 50% neuronal loss and a delay of up to two years before demonstrating severe enough symptoms to achieve diagnosis. Cognoptix is developing a method of early-stage diagnosis to allow treatment before significant neuronal loss and irreversible brain damage occurs.”
The Cognoptix system consists of a laser-based reading device and consumable ophthalmic ointment. The eye exam only takes a few minutes to achieve a result.
The trial involved five AD subjects (two women, three men) ranging from 65 to 83 years old who met the accepted standards for probable Alzheimer’s disease, including an MRI brain scan ruling out stroke or generalized cerebrovascular disease. Five men control subjects, ages 31 to 77 years, had no evidence of cognitive impairment and had normal brain MRIs.
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■ Dr. Sternberg is now AAO president. Paul Sternberg Jr., MD, has begun his term as the 116th AAO president. Dr. Sternberg, who was elected by the Academy’s 32,000 physician and surgeon members, will hold the office for one year. Dr. Sternberg is a nationally recognized leader in ophthalmic education and research as well as a respected retina specialist. He currently serves as the G. W. Hale professor of ophthalmology and chairman of the Vanderbilt Eye Institute of the Vanderbilt University School of Medicine in Nashville, Tenn. ■ Halma acquires MST. Halma announced the acquisition of MicroSurgical Technology Inc. (MST), of Redmond, Wash., a maker of single-use surgical devices, including a range of capsular tension rings for complex cataract surgery cases. The initial cash consideration is $57 million for the share capital plus $2 million for cash retained in the business. Halma now has an extensive ophthalmic device business, which also includes Accutome, Keeler and Volk, among others. Existing MST management will remain in place and continue to operate the business. ■ Jim Mazzo named AcuFocus chairman. James (Jim) Mazzo, formerly president of Abbott Medical Optics, has been named chairman of the board of directors of AcuFocus, developer of an innovative corneal inlay for the correction of presbyopia. ■ Eye injuries from robotic surgery. A study presented at Anesthesiology 2012 found that during the years 2000-2009, eye injuries during robotic-assisted radical prostatectomy (RARP) increased six times, from a 0.07% incidence rate to 0.42% incidence. Approved by the FDA in 2000, RARP has become increasingly used by surgeons to remove the prostate because it is less invasive than conventional radical prostectomy, and offers a shorter hospital stay and faster recovery. In 2000, RARP was used in fewer than 10% of prostate cancer surgeries. In 2008, it accounted for 50 to 80% of all operations. According to Ajay Sampat, MD, and his colleagues from the University of Chicago, RARP procedures require that the patient be positioned head-down in what is called the Trendelenburg position. Consequences include facial swelling, arm injury, as well as corneal and other vision-affecting injuries. In Dr. Sampat’s study, which involved a review of 136,711 RARP cases, most of the visual injuries were from corneal abrasion. Possible causes for the association between RARP and eye injuries include the long duration of surgery, patient positioning or something associated with the robot itself. OM |
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CORRECTION: In the December 2012 article “Dealing With a Medicare Physician Audit,” the wrong CPT code was provided for an “established patient visit - level 5.” The correct code for that encounter is 99215. Ophthalmology Management regrets the error. |
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