PERIPHEREX TRIAL MEETS PRIMARY ENDPOINTS DEMONSTRATES AT-HOME VISUAL FIELDS ARE FEASIBLE AND CORRELATE TO IN-OFFICE TEST

The results of the FDA Registration study show excellent sensitivity to disease detection, and high test-retest reliability.

USA, April 3, 2024 /EINPresswire.com/ -- Peripherex, Inc. today announced positive results from its FDA registration trial that demonstrate that its visual field testing leveraging proprietary, patented eye tracking on a laptop or desktop computer is feasible and correlates well to results achieved in the office. The results of the trial were the foundation for reaching the FDA Registration milestone in Q4 of 2023. The Peripherex app is designed to be run on any computer with a webcam, making it is easy to deploy in the patients’ homes without any additional hardware requirements.

In the IRB-approved trial performed at sites in the US, study subjects were instructed to use the Peripherex software application with advanced eye tracking to monitor their peripheral vision impairment at least once at study enrollment, and then once per week; however, they were able to take the visual field test more than once a week if they chose. Each study subject was prompted by the software when finishing the testing on each eye, to rate how easy the testing process was for them. Humphrey visual field tests (Zeiss HFA) performed at the clinic were used for comparison.

“The excellent interclass correlation coefficient for test-retest reliability, and a sensitivity to abnormal points over 95%, together provide excellent data on real-world, at-home testing using this novel visual field test,” said Jeffrey Goldberg, professor and chair of ophthalmology at the Byers Eye Institute at Stanford University, and a co-founder of Peripherex. Dr. Goldberg and Stanford were not participants in the trial. “Screening for disease and monitoring for progression will be greatly facilitated by expanding testing from the office into the home, or wherever is convenient for patients,” Goldberg added.

Regular home monitoring of visual fields, even with relatively low compliance, has proven to detect progression significantly faster than using in office testing alone, with progression identified in less than 1 year, compared to 2.5 years with in office testing (Ophthalmology 2017;1241735-1742).

“These positive clinical trial results are a major step forward towards realizing a monitoring regimen both patients and practitioners have wanted for a long time – a method of measuring visual fields on a much more regular basis while reducing the burden for the patient, and without crowding the practitioner’s offices,” said Eric Bernabei, CEO of Peripherex. “We will be rolling this solution out in the next few weeks with practitioners across many different practice types, and look forward to full commercial launch later in the year.”

“These data and the upcoming launch of Peripherex’s online testing portal are certainly rewarding, as BioLight saw the potential in this technology very early, and it further proves that technology will continue to improve the lives of patients across all facets of eye care,” said Yaacov Michlin, CEO of BioLight, and Chairman of the Board of Peripherex.

About Peripherex
Peripherex is a pioneer in eyecare diagnostics and insights, transforming the way testing is delivered anywhere, at any time, for everyone. The Peripherex patented eye tracking software platform improves access to care and offers actionable insights earlier in the continuum of care compared to routine check-ups. By expanding access to regular testing modalities and effectively moving testing from the clinic into the home, Peripherex leverages the diagnostic power of the eye to deliver physiologically based health insights to users and healthcare providers. For additional information about Peripherex, please visit https://peripherex.com.

About BIOLIGHT
BioLight Life Sciences Ltd. is a leading company investing in companies and managing projects in the field of eye diseases and ocular treatments. BioLight’s portfolio companies engage in advanced medical devices, medication, diagnostics and digital medicine and all exemplify the enormous potential of Israeli innovation in these fields. For additional information about BioLight, please visit https://bio-light.co.il.

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