It’s been a busy week for ophthalmology research and news after both the Association for Research in Vision and Ophthalmology (ARVO) annual meeting in Seattle and the American Society of Cataract and Refractive Surgery (ASCRS) annual meeting in New Orleans.
Seattle-It’s been a busy week for ophthalmology research and news after both the Association for Research in Vision and Ophthalmology (ARVO) annual meeting in Seattle and the American Society of Cataract and Refractive Surgery (ASCRS) annual meeting in New Orleans.
Bausch + Lomb announced preliminary 2015 results of the Antibiotic Resistance Monitoring in Ocular Microorganisms (ARMOR) surveillance study, the only multi-center, nationwide survey of antibiotic resistance patterns specific to eye care. Researchers also presented data that examined resistance profiles of common bacterial pathogens isolated from the aqueous and vitreous humor to antibiotics routinely used in ophthalmic practice.
In the first study, ARMOR researchers reported comparisons of susceptibility rates available from surveillance in 2015 to results from 2014. At the time of the analysis, a total of 441 isolates of Staphylococcus aureus, coagulase-negative staphylococci (CoNS), Streptococcus pneumoniae, Pseudomonas aeruginosa, and Haemophilus influenza-organisms frequently implicated in bacterial eye infections-were collected from 19 sites across the United States. The isolates were then tested for susceptibility to as many as 15 antibiotics.
Similar to previous years, study authors reported that surveillance data continue to show high levels of antibiotic resistance among staphylococcal isolates, especially among methicillin-resistant (MR) strains, with many demonstrating multidrug resistance. Resistance among the staphylococci was most notable for azithromycin (54-59 percent), oxacillin/methicillin (24-45 percent), and ciprofloxacin (22-28 percent), while CoNS isolates also exhibited high levels of non-susceptibility to tobramycin (19 percent) and trimethoprim (26 percent).
In 2015, 20 percent of S. aureus isolates and 39 percent of CoNS isolates were non-susceptible to three or more drug classes, with multidrug resistance remaining prevalent among MR S. aureus (67 percent) and MRCoNS (74 percent). Isolates of S. pneumoniae remained susceptible to fluoroquinolones and chloramphenicol, while non-susceptibility to azithromycin and penicillin was 50 percent and 38 percent, respectively. Resistance among P. aeruginosa isolates continues to be low, while H. influenzae isolates were generally susceptible to all antibiotics tested.
“These latest data demonstrate that resistance of common ocular pathogens to several commonly used antibiotics continues to be a challenge,” says Penny Asbell, MD, lead ARMOR study author, professor of ophthalmology at Icahn School of Medicine at Mount Sinai, and director of the Cornea Service and Refractive Surgery Center at The Mount Sinai Hospital. “Understanding antibiotic resistance patterns is critical for the selection of effective agents to treat potentially sight-threatening ocular infections. The ARMOR data allow physicians to select agents that have proven efficacy and a broad spectrum of activity.”
In a second study, investigators examined antibiotic resistance profiles of 172 aqueous and vitreous humor isolates collected between 2009 through 2015 through the ARMOR surveillance study, including 30 S. aureus, 100 CoNS, 21 S. pneumoniae, 10 P. aeruginosa, and 11 H. influenzae. Similar to the preliminary 2015 ARMOR findings, researchers reported that antibiotic resistance was prevalent among staphylococcal isolates, particularly CoNS, with many demonstrating multidrug resistance.
Pterostilbene (PS), a natural dietary compound found in blueberries and chemically related to resveratrol, protects against dry eye disease. When introduced to human corneal epithelial cells, PS significantly reduced the levels of oxidative damage, in turn reducing inflammation.
“It's not surprising to me that organic compounds will help reduce ocular surface stress and oxidation,” says Optometry Times Editorial Advisory Board member Leslie O’Dell, OD, FAAO. “It's exciting to have data supporting that pterostilbene decreases oxidative stress on the human cornea. My role as a nutritionist continues to grow for my patient from posterior segment disease to the anterior segment.”
Ebola survivors may be at risk of severe vision loss or blindness weeks after being declared virus-free.
Researchers performed a retrospective review of 50 Ebola survivors with uveitis from a cohort of 277 Ebola survivors in Sierra Leone. The study found that approximately one in five Ebola survivors develops uveitis a median of three weeks after being discharged from treatment centers, and a third of those patients develop severe vision impairment or blindness.
Researchers say the study’s results highlight the urgent need for eyecare providers and resources in the Ebola-affected areas.
Researchers presented the latest on the ARGUS II, a prosthesis that restores some central vision in patients with only limited peripheral vision remaining. Four patients with significant central vision loss from dry age-related macular degeneration (AMD) received the implant.
Patients did not report any confusion with the implant on and both eyes open. According to researchers, one patient performed significantly better on direction and motion testing with the system on than off, and the patient reported he could recognize the outline of faces and some facial characteristics, such as an opened/closed mouth within his central vision.
Optometry Times Editorial Advisory Board member Steven Ferucci, OD, FAAO, says Argus II is approved by the U.S. Food and Drug Administration for use only in patients with profound vision loss from retinitis pigmentosa. This latest study was the first time Argus II was used in patients with dry AMD.
“This is the first step to see if the Argus II could be beneficial in patients with dry AMD, specifically geographic atrophy,” says Dr. Ferucci. “While only four patients, and a short follow-up (0.2 to 5.6 months), not much can be drawn other than the procedure was mostly successful, and the patients seem to tolerate the Argus II-at least initially.”
He says there will need to be follow-up studies to assess any long-term complications, but this study is the first step to figure out if this technology will be useful for patients with dry AMD.
A medicated silicone ring that rests on the surface of the eye reduced eye pressure in glaucoma patients by about 20 percent over six months.
The thin silicone ring made by ForSight Vision5 is suffused with medication that slowly releases over time, and it is designed to be replaced by an ophthalmologist every six months. This eliminates the need for glaucoma patients to regularly instill medicated eye drops themselves.
Ophthalmologists at 10 sites nationwide tested the ring in a Phase 2 clinical trial on patients with glaucoma or ocular hypertension. In the study, 64 patients received the topical ocular insert containing bimatoprost (Lumigan, Allergan). Patients were also supplied with artificial tears. The control group of 66 patients wore an insert treated with no drug but twice a day used 0.5 percent timolol (Timoptic, Merck) drops, the regulatory benchmark for glaucoma drugs. Intraocular pressure (IOP) in the bimatoprost group fell 3.2 to 6.4 mm Hg over six months, in comparison to 4.2 to 6.4 mm HG for the timolol group. Overall, IOP decreased in the group wearing the bimatoprost ring by about 20 percent from the initial measurements over six months.
Researchers said the device was well tolerated and safe with a high retention rate of 89 percent for both groups at six months. The ring became dislodged in 15 patients but was replaced each time, allowing therapy to continue. Some patients experienced itchiness and eye redness, which is not unusual for patients taking glaucoma medication.
“Some sort of slow-releasing device such is this one will definitely come to fruition one day,” says Optometry Times Editorial Advisory Board member Ben Casella, OD, FAAO, “and studies show that compliance goes down when more drops are needed in one’s regimen. State associations should examine their laws with respect to the ability to prescribe sustained release inserts in preparation for therapies such as this.”
A Phase 3 study of a larger group of patients is expected to begin later in 2016. The study authors noted the device could also be used for non-glaucoma medications, with potential applications for dry eye, allergies, and inflammation. In addition, the non-invasive nature of the device and its relatively large surface area make this technology a potential candidate for delivering multiple ocular drugs at once, further reducing the burden of self-administration on patients.
LumiThera Inc. released clinical data results from the TORPA II study of non-invasive photobiomodulation (PBM) treatment in dry age-related macular degeneration (AMD) subjects.
Clinical data from 42 eyes in 24 dry AMD subjects demonstrated a significant improvement in mean visual acuity (VA) of 5.90 letters on completion of the three-week treatment and maintained at 5.14 letters after three months. Contrast sensitivity (CS) improved significantly at three weeks and three months.
An independent retinal-imaging expert conducted the anatomical assessments of the morphology. Drusen volume decreased by 0.024 mm, and central drusen thickness was significantly reduced by a mean of 3.78 µm, while overall central retinal thickness and retinal volume remained constant.
This is the first instance of statistically significant improvement in both functional clinical VA and CS and objective anatomical (OCT drusen volume and central drusen thickness reduction) findings reported in dry AMD subjects with PBM therapy, according to the company. The results demonstrate a sustained and potential disease modifying effect following a short non-invasive PBM treatment course.
The results have led to the design of the Lightsite study, a 30-subject, randomized, double-masked, sham-controlled clinical trial currently enrolling in Canada. The study is partially funded by a NIH National Eye Institute grant to LumiThera and will utilize the LT-300 instrument and multi-wavelength protocol.
"As we move toward the commercialization of LT-300, clinical studies such as TORPA I and II and LIGHTSITE will provide critical patient data and protocols necessary for long-term acceptance in the ophthalmic community," says LumiThera CEO Clark Tedford, PhD, in a statement.
Bausch + Lomb received approval from the U.S. Food and Drug Administration (FDA) for a number of enhancements to its Trulign Toric IOL calculator.
The FDA approval of the company’s recent enhancements to the Trulign Toric calculator enhancements, which were updated based on direct feedback from customers, will include a number of refinements allowing users to:
• Interface directly with the IOLMaster or Lenstar systems to help facilitate the input of patient data and create a seamless user experience
• Display the make and model of the Crystalens IOL, if a non-toric lens is recommended while displaying the intraocular lens IOL at 90 degrees with no axis of alignment
Bausch + Lomb also announced a collaboration to develop an iPhone and iPad app for cataract surgeons. The app will help surgeons streamline their workflow by delivering patient information and clinical insights as well as IOL options on a single, digital platform at the point of care.
The app will be designed to provide surgeons with access to information that patients have agreed to share, enabling doctors to plan their surgical interventions-including IOL selection-and have the option to view the information on digital devices or display screens during surgery.
The app will be designed to electronically manage patient data across iPhone and iPad while hosting health-related data on IBM Cloud Platform, Bluemix, and relaying customized IOL options to surgeons. The MobileFirst for iOS team, which is part of IBM Global Business Services, will design and develop this custom app for Bausch + Lomb. Bausch + Lomb plans to use the app to collect data over time, resulting in a cognitive app that applies machine-based learning and predictive analytics to deliver real-time insights to surgeons.
By compiling each cataract patient’s information in the app-including IOL calculations, corneal topography and other biometry results as well as lifestyle preferences-surgeons and their staff may generate a comprehensive, integrated profile to help them facilitate IOL selection and procedure planning. Historical surgical data and other patient insights can also be housed within the app to potentially support positive clinical outcomes for future cataract.
Pilot study testing for the new application is expected to begin in late 2016.
Bausch + Lomb is also preparing to launch its FortifEYE capsular tension ring (CTR).
“We know that CTRs are an important part of many of our customers’ armamentarium, so we look forward to providing our customers an exceptional CTR that has the significant benefits of a posterior chamber IOL,” says Andy Chang, senior vice president and general manager, U.S. Surgical, Bausch + Lomb.
The company expects to receive FDA approval for the use and commercialization of FortifEYE CTR later this year.
Reliance Medical Products and Haag-Streit USA launched the I-Ops In-Office Procedure System, an ergonomically optimized instrument delivery system that allows physicians to efficiently perform injections and other minor in-office procedures.
Physicians can now perform a multitude of procedures without the need for an assistant or the need to turn around and reach for supplies, according to the company. By increasing productivity and efficiency, physicians may be able to see more patients during the day.
The modular I-OPS System features a durable tray with space for up to nine interchangeable inserts. The ability to organize and set up procedures beforehand brings consistency and standardization to procedures, which can save time and also reduce the risk of medical errors.
The I-OPS tray and accessory kit come with two syringe holders, deep and shallow cups and one each of a dropper bottle holder, twist bottle holder, and gel pack holder. If the physician prefers to customize his system, inserts are available for purchase in any combination a la carte.
The basic I-OPS arm fits almost any manufacturer’s stand pole and is easy to move to swing out of the way of patients.