Second Sight Medical (EYES) Announces Publication of Positive Argus II Phase 3 Data
Second Sight Medical Products, Inc. (Nasdaq: EYES) announced the publication of a positive 3-year FLORA study in the Australian journal Clinical And Experimental Optometry for the Argus II Retinal Prosthesis System (“Argus II”).
The Functional Low-Vision Observer Rated Assessment (FLORA), a multi-part instrument that was developed specifically for use in patients implanted with a retinal prosthesis who suffer from profound loss of vision or blindness, was used to assess the functional visual abilities of 26 blind patients and how they use the Argus II to complete a series of common activities of daily living. Before the development of the FLORA, there were no accepted, standardized assessments of functional vision or quality of life that could be used to assess the kind of vision that is restored by a retinal prosthesis. Common assessment tools of functional vision that are available such as the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) or the Massof Activity Inventory have only a few items that can be completed by those with ultra-low vision, with the majority of test items requiring higher levels of spatial vision (ability to read, recognize faces, identify colors).
Study subjects served as their own controls and completion of tasks were compared with the system “ON” versus “OFF”
24 of 35 tasks (69%) showed a statistically significant improvement in outcome with the device “ON” versus “OFF” while only two tasks (6%) showed a decrease in outcome. Nine tasks (26%) showed no significant change.
“We are thrilled, yet not surprised, with the results of this study,” said Will McGuire, President and CEO of Second Sight. “Since the beginning, we have heard from the majority of individuals with the Argus II that our technology has changed their life and greatly enhanced their ability to perform tasks and activities of daily life………
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Source: Street Insider