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New NEI Study Finds Patients at High-Risk for Developing Neovascular Age-Related Macular Degeneration Benefit from Home Monitoring for Early Detection of CNV

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HOME Study Saves Vision

ST. LOUIS–(BUSINESS WIRE)–November 18, 2013–

The results of the Home Monitoring of the Eye (HOME) study, a subset of the Age-Related Eye Disease Study 2 (AREDS2) clinical centers* was presented last week at the annual meeting of the American Academy of Ophthalmology (AAO). The study revealed that participants at high risk for developing choroidal neovascularization (CNV), the neovascular or wet phase of age-related macular degeneration (AMD), who used the ForeseeHome monitoring device strategy, the only technology of its kind on the market for AMD patients, had significantly better preservation of their visual acuity at the time of CNV detection than the control group of participants who were only using standard care methods to self monitor their AMD for progression. The study’s Data Safety and Monitoring Committee recommended early termination of the study on April 2, 2013 based on superior vision outcomes among the participants randomly assigned to use the home device.

The HOME Study was a collaborative effort led by the National Eye Institute to evaluate the performance of the home monitoring device plus standard care compared to standard care monitoring alone for the detection of AMD progression to the neovascular phase. Current methods for CNV detection in-between routine, scheduled visits to a physician lack the sensitivity and are not addressing the unmet need to identify CNV earlier in the disease progression with good, functional levels of vision. As treatments to manage the neovascular phase of AMD have improved, the importance of early detection of this event has increased in an effort to optimize outcomes following treatment of neovascular AMD. Approximately 8 million individuals in the United States, age 50 and older, are estimated to have intermediate (large drusen) or advanced AMD in one eye, placing them at high risk of progression to AMD, ranging from 25 to 50% over a five-year period. ForeseeHome represents an important evolution in the earlier detection of CNV, similar to the revolutionary treatment advances achieved from the introduction of anti-Vascular Endothelial Growth Factors therapy for CNV management. With earlier detection of CNV, vision-preserving treatments can be initiated sooner in the disease process, resulting in optimal long-term vision outcomes.

The results of the HOME study show that 94% of participants with high risk for developing CNV maintained 20/40 vision or better at the time they were diagnosed with CNV while using ForeseeHome at the recommended frequency, compared to 62% in the standard care alone group. Also, in contrast to current home monitoring strategies, those with intermediate AMD (bilateral large drusen) or advanced AMD in 1 eye are likely to benefit from home monitoring with the ForeseeHome device to detect the development of CNV at an earlier stage with better preservation of their visual acuity to maximize visual acuity results after intravitreal therapy with anti-VEGF agents.

“The very positive findings and early termination of the study led the company to accelerate its commercial launch plans,” said Barak Azmon, M.D., CEO and co-founder of Notal Vision. “We are privileged to be able to offer a proven and effective tool for self-monitoring to millions of patients that are at risk, and fear losing sight to AMD, millions that are eager to take an active part in managing their disease.”

The ForeseeHome™ AMD Monitoring Program is a prescription-based, comprehensive telemonitoring and data management system that extends the management of AMD to patients’ homes between office visits, providing access to both patients and physicians to monitor one’s progression to CNV, and alerting physicians to immediate, significant visual field changes in their patients, so that timely follow-up and treatment may be initiated. The ForeseeHome AMD Monitoring Program utilizes a simple to use device based on preferential hyperacuity perimetry, a form of macular-field testing, to identify minute visual distortions, or metamorphopsia, for the detection of early CNV disease.

Notal Vision markets the ForeseeHome AMD Monitoring Program in the U.S., and has collected data on CNV progression from more than 750,000 tests taken by patients enrolled into the program. For more information about enrollment into the ForeseeHome AMD Monitoring Program please visit www.foreseehome.com or contact 1-800-910-2020.

About Notal Vision™

Notal Vision was founded by two ophthalmologists, and is committed to providing retina specialists with innovative, home-based, technology solutions that support visual health in patients with AMD and other retinal diseases. The company’s ForeseeHome® device is the first FDA-cleared home telemonitoring device that detects and characterizes visual distortion in AMD patients as an aid to monitoring progression to CNV.

* The HOME study was executed by the National Eye Institute, in collaboration with EMMES Corporation and sponsored by Notal Vision Ltd. Tel Aviv, Israel.

Media:
Mona Finston, 646-326-4607
Mona@pascalecommunications.com
or
Company:
Natasa Jovic, 314-503-1375
Natasa.jovic@notalvision.com


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