Notal Vision shares data on novel home OCT device

The Notal Vision Home OCT incorporates a deep learning-based algorithm, called Notal OCT Analyzer (NOA). (Image courtesy stock.adobe.com)

Notal Vision Inc. recently reported the latest data on its investigational home-based optical coherence tomography (OCT) and how the service can be used to manage wet age-related macular degeneration (AMD).

The results were recently presented at the Angiogenesis, Exudation, and Degeneration and Macula Society 2023 meetings by Nancy Holekamp, MD, Pepose Vision Institute.

According to a press release from the company,¹ they are developing technology designed to provide patient-initiated retinal OCT scans to support the management of patients with wet AMD, complementing existing standard of care treatments as well as emerging longer-acting drugs and drug delivery systems.

In her presentation, Holekamp reviewed several clinical trials that show the progress toward implementing home OCT in the management of patients with wet AMD. According to the release, the trials assessed the usability of the device by patients, demonstrated extended use of the device at home by patients, assessed the interpretation of the home OCT images by a reading center, and driving patient management with AI-based notifications and physician review of home OCT data under IRB approved protocol. The clinical trials had participation of over 200 subjects and more than 8 retina specialists.

“The experience with home OCT has given me an understanding of the value of missing information in between the office visits,” Holekamp said. “I believe the technology will have a twofold impact: individualizing the care of patients and better understanding the dynamics of AMD.”

According to the release, The Notal Vision Home OCT incorporates a deep learning-based algorithm, called Notal OCT Analyzer (NOA). This algorithm is used for automatic quantification of retinal fluid which is a key biomarker in wet AMD treatment efficacy. This provides physicians with additional information not currently provided by the standard of care clinical evaluations, according to the release.

Anat Loewenstein, MD, professor and director of the Department of Ophthalmology at Tel Aviv Medical Center in Tel Aviv, Israel, reviewed the characteristics of disease reactivation, treatment responses, and demonstrated heterogeneity across the studied patients.

“The purpose was to evaluate the effect of timely treatment and the implications and benefits of incorporating home OCT into patient care,” said Prof. Loewenstein. “I think home OCT will change significantly the way we manage the patient.”

Dinah Zur, MD, from the Tel Aviv Medical Center, also reviewed the use of NOA in analyzing in-office OCT images of 4,485 eyes from 3,637 patients in the BIRAX project with the University of Belfast and Tel Aviv Medical Center, which aims to provide measurable indicators to enable models for personalized treatment approaches in wet AMD.

According to the release, Home OCT has received a “Breakthrough Device” designation by the U.S. Food and Drug Administration (FDA). Notal Vision looks to release Home OCT in Q4 2023, following an FDA premarket review, to US-based clinics that partner with its Medicare-accredited monitoring center through patient referral.

Fluid volume trajectories of (up to) daily Home OCT images processed by NOA deep learning algorithm (Image courtesy Notal Vision)

References:

1. Clinical trials results demonstrate value of home OCT at international meetings. Press release. Notal Vision. February 22, 2023. Accessed February 23, 2023. https://notalvision.com/assets/press-releases/Feb-22-2023-Clinical-trials-results-demonstrate-value-of-home-OCT-at-international-meetings.pdf