Isolate studies prepare doctors to fight antibiotic resistance

Researchers examined 5,000 isolates over 10 years.

By Robert Stoneback, associate editor

A study that examined 3,000 ocular isolates from across the United States gave insight into the increasing difficulty of antibiotic resistance.

This resistance among infection-causing organisms represents “a growing problem worldwide,” according to Penny Asbell, MD, lead investigator of the Antibiotic Resistance Monitoring in Ocular Microorganisms (ARMOR) study. Dr. Asbell presented results from the ongoing ARMOR study and its predecessor, Ocular TRUST (Tracking Resistance in US Today) at the AAO meeting in October.

The findings presented at AAO were based on 10 years of cumulative data, including three years from TRUST and seven years of ARMOR data.

Dr. Asbell presented findings from more than 5,000 isolates. About 1,000 came from Ocular TRUST and the rest came from the ARMOR study, which is sponsored by Bausch + Lomb.

The antibiotics examined during TRUST and ARMOR include ciprofloxacin, azithromycin, clindamycin, chloramphenicol, tobramycin, ceftriaxone, imipenem, oxacillin, vancomycin, trimethoprim, gatifloxacin, levofloxacin, moxifloxacin, methicillin and polymyxin B.

Among the Staphylococcus aureus isolates investigated by the researchers, 38% were methicillin resistant S. aureus (MRSA), says Dr. Asbell. In addition, 50% of the coagulase-negative staphylococci (CoNS) isolates were found to be methicillin resistant.

The Streptococcus pneumoniae isolates’ resistance to azithromycin increased over the course of the TRUST and ARMOR study, from 22% in 2006 to 43.6% in 2015, according to ARMOR study co-author Heleen DeCory, PhD.

S. aureus and CoNS both had small but significant resistance decreases to different antibiotics, continues Dr. DeCory; for S. aureus, its resistance to methicillin, ciprofloxacin and tobramycin decreased. For CoNS, it was methicillin and ciprofloxacin.

Multidrug resistance was also common among the isolates.

“We saw multidrug resistance in the majority of MRSA and methicillin resistant CoNS,” says Dr. Asbell.

That level of methicillin resistance “is a feared event, because often those organisms are not sensitive to many antibiotics and in some instances can cause death or serious infection even in a healthy person,” says Dr. Asbell. “It’s one of the things that’s been looked at as we look at the problem of antibiotic resistance.”

However, ophthalmologists do have an advantage over other medical specialties in that they are more frequently treating topical infections such as conjunctivitis. This means, says Dr. Asbell, they can often “drown the eye in antibiotics” to “overcome the resistance and still get a good outcome.”

“The bottom line, looking at the surveillance study, is no one antibiotic is going to cover everything,” says Dr. Asbell. There’s no good way to determine if a patient might be resistant to a specific antibiotic based on their physical characteristics, she continues.

The data from the ARMOR and Ocular TRUST studies can be useful to decide on an antibody before specific lab results for a patient are completed. From there, an individualized treatment can be established.

Dr. Asbell asks doctors to keep the following points in mind when picking antibiotics:

• Use antibiotics wisely ­— using them “as if they’re water” will only increase resistance to that antibody.
• Not every antibiotic will work every time.
• Even broad spectrum antibiotics may not cover everything.
• Use studies like ARMOR and TRUST to help with initial antibody selection.
• After picking an initial antibody, monitor how the patient responds to the treatment.
• When judging antibiotics via minimal inhibitory concentration, remember the numbers relate to lab tests, not people.
• Vancomycin still works, but is not typically used topically.
• Look out for antibody penetration.

JAMA Ophthalmology published ARMOR study data in December 2015, which can be read at http://tinyurl.com/gqdz5px . TRUST can be viewed at http://tinyurl.com/hngauv8 . OM

Trump’s win scuttles CMS reimbursement plan

Payments for Lucentis and Eylea were at risk.

By Jerry Helzner, contributing editor

A CMS “demonstration plan” that would have rewarded physicians for administering less costly Medicare Part B drugs and penalized them for using their more costly counterparts looks to have withered on the decimated Democratic vine following Donald Trump’s election victory.

Spokespersons for ophthalmic and oncologic organizations, the two specialties that would have felt the plan’s financial impact the most, said the Obama administration’s willingness to let a key late November deadline pass without taking any action clearly signaled that the administration has conceded the battle. CMS received more than 1,300 public comments after the plan was announced in March, with the overwhelming majority opposed to implementation.

Cathy Cohen, AAO vice president for governmental affairs, said the Obama administration had proffered the demonstration plan without consulting with representatives of those medical specialties that would be most affected, thus creating widespread opposition to what the AAO considered a flawed and ill-informed plan.

During the public comment period, the AAO, ASCRS and the Retina Society published a joint letter to CMS pointing out that retina specialists would almost certainly lose money on every injection of Lucentis (Genentech) and Eylea (Regeneron) if the lower proposed reimbursement were put into effect. The reimbursement formula recommended by CMS would not have covered the overhead for procuring, storing, administering, tracking and applying for reimbursement for the two leading FDA-approved anti-VEGF drugs, the letter said. OM

Patient data bring KAMRA into focus

AcuFocus made changes to its inlay procedure based on physician feedback.

By Robert Stoneback, associate editor

Hundreds of patients helped improve AcuFocus’ KAMRA inlay, thanks to a registry of patient data submitted by trained KAMRA surgeons.

The KAMRA inlay, designed to restore near vision, is inserted into a corneal pocket, created via a femtosecond laser, to help focus light.

AcuFocus asked its physicians to contribute results and data from their first 20 KAMRA patients. From that information, AcuFocus learned that its original instructions for inserting the KAMRA did not provide the best patient outcomes, according to Melissa Warwick, medical education and public relations manager for AcuFocus.

Some of the information came from its international physicians, who are no longer contributing data.

The original instructions called for creating a flap to insert the KAMRA, but inserting it via an intrastromal pocket had better results. AcuFocus also learned that a smoother stromal bed for the inlay could be created by using a spotline that was six by six microns or smaller.

A deeper implantation depth also helped. The original instructions for the pocket were to create it between 150 microns and 250 microns. However, surgeons found that creating the pocket at a depth shallower than 250 microns resulted in more keratocytes and less wound healing. Wound healing was improved by implanting the KAMRA at 250 microns.

A study on the KAMRA’s clinical utility made a similar conclusion about the pocket method. The study noted the pocket technique not only allows for better centration, but its smaller incision size also results in fewer cuts to the corneal nerves, reducing the chance of postoperative dry eye.¹

No KAMRA procedures using the flap method have been performed in the United States since its U.S. launch in 2015, according to Ms. Warwick.

AcuFocus is “continually collecting data as new surgeons become trained” in the KAMRA procedure, she says. There are currently no plans to alter the procedure further. “We are very confident in the procedure we have rolled out in the United States.”

AcuFocus’ new product, the IC-8 IOL, received a CE Mark in 2015 and is available in Australia and parts of Europe. Clinical trials for the IC-8 have not yet begun in the United States. According to AcuFocus, it is designed to aid vision in presbyopic cataract patients. OM

REFERENCE

1. Naroo SA, Bilkhu PS. Clinical utility of the KAMRA corneal inlay. Clin Ophthalmol. 2016;10:913-919.

Study calls for U.S. action against vision impairments

Awareness campaigns and better surveillance.

By Karen Blum, contributing editor

Agencies like the Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention, as well as state and local public health departments, should launch public awareness campaigns for better vision and eye health; establish better surveillance systems for vision health; and develop a common research agenda targeting the causes, risks and protective factors for vision impairment, according to a recent consensus study from the National Academies of Sciences, Engineering, and Medicine.

The report, “Making Eye Health a Population Health Imperative: Vision for Tomorrow,” includes nine broad recommendations intended to reduce visual impairment and promote eye health in the United States.

They include a national call to action to reduce vision impairment through steps like eliminating correctable vision impairment by 2030; a need to establish a single set of evidence-based clinical guidelines to be used by eye- care professionals; and the need to proactively recruit and educate a diverse healthcare workforce, and incorporate prevention and detection of visual impairments among core competencies in medical education and training curricula. In addition, the report said, state and local public health departments should identify and eliminate barriers to eye care such as comprehensive eye exams, appropriate screenings and follow-up services.

Aging population, hefty pricetag

An estimated 142 million Americans over age 40 have some vision problems, committee members said during the briefing. In addition, there are 1.2 million uncorrected cataracts, and between 8.2 million and 15.9 million U.S. citizens are affected by uncorrected or undiagnosed refractive errors, costing annually $139 billion.

“This problem is not going away,” said study chair Steven Teutsch, MD, MPH, an independent consultant and adjunct professor at the University of California-Los Angeles Fielding School of Public Health.

Over the next 40 years or so, he said, “the aging of the population will lead to a very large increase, a doubling, of the amount of vision impairment in the U.S. if we don’t address the problem.”

The work was sponsored by 10 organizations including the AAO, the Association for Research in Vision and Ophthalmology and the CDC.

The report can be accessed online at http://www.nationalacademies.org/hmd/Reports/2016/making-eye-health-a-population-health-imperative-vision-for-tomorrow.aspx .

A meeting between key stakeholders to discuss the issue is scheduled for early 2017, according to Prevent Blindness. The meeting is being coordinated by the Health and Medicine Division of the National Academies of Sciences, Engineering, and Medicine and the CDC.

Following the election of Donald Trump for president, Prevent Blindness sent a letter to the president-elect and his transition team urging them to consider the growing impact of vision problems on American health and economy.

The letter states that the current financial cost of these problems is $145 billion, with the potential to increase to $717 billion over the coming decades.

In conjunction with the report, Research to Prevent Blindness, another study sponsor, in July launched The Focus Initiative, a virtual forum for people working in vision and public health to share resources like research results or webinars. For more information, call 800-331-2020 or visit http://www.preventblindness.org/focus-initiative .

The Focus Initiative also has a LinkedIn group at www.preventblindness.org/linkedin . OM