News and Innovations
iStent Inject Plus Topical Travoprost Provides Sustained IOP Reduction
A study of 53 open-angle glaucoma patients showed that the iStent Inject (Glaukos) combined with topical travoprost lowered mean IOP 35% to 12.9 mm Hg after 18 months.1
All subjects enrolled in this prospective, international study had open-angle glaucoma that was not controlled on two preoperative topical medications. The preoperative medicated mean IOP was 19.7 mm Hg.
One day after implantation of two iStent Inject stents in a standalone procedure, all patients began a regimen of topical travoprost. Eleven surgeons performed the procedures, and no device-related adverse events occurred through 18 months.
At 12 months, 91% of eyes achieved at least a 20% decrease in IOP with the reduction of one medication. At 12 months, 100% of eyes achieved IOP less than or equal to 18 mm Hg, and 87% of eyes achieved an IOP less than or equal to 15 mm Hg, with the reduction of one medication. Following a medication washout at 13 months, the mean unmedicated IOP decreased 33% to 16.6 mm Hg versus 24.9 mm Hg preoperatively.
“The results of this study underscore the viability of using iStent Inject together with a single postoperative prostaglandin medication to consistently manage IOP to levels in the 15 mm Hg range,” John Berdahl MD, who coauthored the article, said in a Glaukos news release. Glaukos sponsored the study.
1. Berdahl J, Voskanyan L, Myers J, et al. Implantation of two second-generation trabecular micro-bypass stents and topical travoprost in open-angle glaucoma not controlled on two preoperative medications: 18-month follow-up [published online June 2, 2017.] Clin Exp Ophthalmol. doi:10.1111/ceo.12958.
Inotek Fixed-Dose Combination Trial Shows No Clinical Advantage in IOP Reduction
A phase 2 study found that the addition of trabodenoson 3% to latanoprost 0.005% (Inotek Pharmecueticals) offered no clinically meaningful advantage in IOP reduction over latanoprost alone at day 56, according to an Inotek press release.
Previously, the study showed that, at 28 days of once-daily morning treatment, the fixed combination showed a 1.2 mm Hg improvement in IOP reduction compared to latanoprost alone, but the effect disappeared after 4 additional weeks of treatment and night-time dosing.
The randomized, double-masked, phase 2, dose-ranging trial assessed the overall risk/benefit profile of binocular topical application of different daily doses of trabodenoson (3.0% and 6.0%) when combined with latanoprost (0.005% or 0.0025%) for 8 weeks in 201 patients with ocular hypertension or primary open-angle glaucoma.
The trial enrolled subjects with an IOP greater than or equal to 25 mm Hg and less than or equal to 34 mm Hg. The primary endpoint of the fixed-dose combination trial measured IOP reduction from diurnal baseline for a 2-month treatment period. The treatment period was divided into two 4-week periods.
Grant Will Fund Research of Biomechanical Markers in Glaucoma
Massimo A. Fazio, PhD, and Christopher A. Girkin, MD, at the University of Alabama at Birmingham Department of Ophthalmology, received a 4-year, $2.55 million R01 grant from the National Eye Institute to explore how visual field loss developed with glaucoma is associated with individual-specific biomechanics of the eye, according to a university news release.
This new study will explore the role of biomechanical differences in the optic nerve that may explain why individuals of African descent are at greatest risk of developing glaucoma. It applies Dr. Fazio’s novel computational approaches to a large multicenter cohort of patients observed in the African Descent and Glaucoma Evaluation Study (ADAGES). Prior studies of this cohort have defined racial difference in progression of glaucoma (ADAGES 1 and 2) along with genetic factors (ADAGES 3).
Dr. Fazio is working with Heidelberg Engineering to use optical coherence tomography to uncover 3-D structural and biomechanical parameters that show racial differences in the mechanical behavior of the optic nerve that may put individuals of African descent at greater risk for blindness from glaucoma. This study will define these structural and biomechanical differences in the optic nerve that exist between people of European and African descent and how these differences increase the rate of glaucomatous progression and disease susceptibility within this at-risk minority group.
Dr. Fazio noted in the press release that the collagen structure and biomechanics are different between the two groups and are therefore correlated with a different rate of damage.
New Laser Procedure for Glaucoma
At this year’s World Glaucoma Congress, held June 28 through July 1, Quantel Medical launched the SubCyclo laser procedure for the treatment of primary open-angle glaucoma and angle-closure glaucoma, according to a company news release. SubCyclo is a novel nonthermal glaucoma treatment based on the transscleral cyclophotocoagulation principle. According to the company, the procedure lowers IOP by stimulating the ciliary body and the uveoscleral pathway, a route of aqueous outflow, without destructive effects. Because it is not destructive, the procedure can be used earlier in the disease process, the company noted in the press release. The SubCyclo probe is available on Quantel’s Supra 810 laser.
Allergan Settles Whistleblower Lawsuit
Allergan settled a whistle-blower lawsuit brought by Herbert J. Nevyas, MD, and Anita Nevyas-Wallace, MD, who alleged the company provided paid speaking engage- ments, free business consulting, and other services as an inducement for physicians to prescribe Restasis, Acular LS, and other eye care medications.1
Allergan agreed to pay $13 million to settle the case, and the funds will be shared by Nevyas and Nevyas-Wallace, the federal government, and 19 states involved in the action. Under federal law, Nevyas and Nevyas-Wallace may claim up to 30% of the settlement amount.
1. Mondics C. Allergan settles whistleblower lawsuit filed by two area doctors. httpL//philly.com. Published June 30, 2017. Accessed July 5, 2017.
NIH Awards Grant to Develop Therapy for Bacterial Keratitis
Wayne State University received a 5-year, $1.925 million grant from the National Eye Institute of the National Institutes of Health to test the role of microRNAs, a newly recognized level of gene expression regulation, in bacterial keratitis and to identify new therapeutic targets and alternative treatment strategies.
“In our previous studies, we discovered that anti-miR-183/96/182 enhances the ability of innate immune cells, including macrophages and neutrophils from our blood, to engulf and kill bacteria,” said Shunbin Xu, MD, PhD, associate professor of ophthalmology and anatomy and cell biology in the School of Medicine at Wayne State University in a press release. “This also limits inflammatory responses and collateral damage to the corneal tissue.”
The goal of this grant, “The miR-183/96/182 Cluster in Pseudomonas Aeruginosa-Induced Keratitis” (grant number EY026059), is to uncover the underlying molecular mechanisms by which the cluster enhances the innate immunity. It may lead to the development of new approaches to combat antibiotic-resistant bacterial infections and tumors that evade the surveillance of our innate immune system.
Ophthalmic Device Market Expected to Grow 5.5%
Market Data Forecast reported that the global ophthalmology devices market is expected to reach $45.1 billion by 2021, with a cumulative growth of 5.5%, according to a news release. The aging population, development of health care infrastructure, and lifestyle-related diseases are among the driving factors for the ophthalmology devices market. The lower adoption of phacoemulsification devices and premium IOLs in emerging regions represents a huge untapped market opportunity.
North America represents the largest regional market, followed by Europe. The Asia-Pacific region is expected to register the highest market growth in coming years. A majority of the growth in this region is driven by the growing population in countries like China and India, improving health care infrastructure, growing per capita income, and a rising focus of key market players on this region.
The optical coherence tomography (OCT) scanners segment accounted for the largest share of the ophthalmology diagnostic and monitoring devices market in 2015. Market Scope estimates that the OCT market will generate $697 million in total manufacturer revenues in 2017, and the market will grow to $865 million by 2022 at a compounded annual growth rate of 4.4%. The ophthalmic diagnostic market as a whole is a $3.3 billion market, of which OCT units make up one-fifth of overall revenues.
Much of this growth will come from software upgrades and demand for new devices to replace those currently in use, as well as expansion of eye care services in developing markets. Recent innovations, such as systems combining OCT technology with fundus imaging or scanning laser ophthalmoscope technology, are growing in popularity. In addition, more companies are offering OCT angiography software.
The US market represents more than a third of global market revenues, largely due to lucrative markets for retinal evaluation and intraoperative surgical equipment. Market Scope anticipates faster growth over the next 5 years in emerging markets, including China and India.
1. Large-Scale Production of Living Brain Cells Enables New Research
With the help of a new method for cell conversion, researchers at Lund University in Sweden have found a way to produce diseased, aging brain cells on a large scale in a cell culture dish.
2. The Presence of a Smartphone Reduces Brain Power
Research suggests that cognitive capacity is reduced when a smartphone is within reach, even if it is turned off.
3. Sense of Smell May Affect Weight
Researchers discovered that mice that lost their sense of smell could eat a high-fat diet and stay at a normal weight, while mice with a normal sense of smell doubled their weight, suggesting a link between smell and metabolism.
4. From Electronics to Eye Drops: The Promise of Quantum Dots
Quantum dots, currently used in TVs and tablet displays, may someday provide relief for bacterial keratitis, animal studies suggest.
5. Rare Cancer Reignites Debate Over Breast Implants’ Safety
Women with textured implants are more likely to be diagnosed with rare anaplastic large-cell lymphoma.
Clearing the Record
The original Figure 2 from the article “Cyclophotocoagulation Controversy” by James Fox, MD, that ran in our March/April 2017 edition did not show correct positioning of the MicroPulse P3 probe (Iridex). With a properly positioned probe, the notch (red arrow) is toward the limbus, and the flat side (blue arrow) is toward the eyelid.