Eyerising’s device has met safety and efficacy standards in more than 30 countries

The Australian manufacturer of the repeated low-level red-light (RLRL) Eyerising Myopia Management Device has strongly rebutted claims made by University of Houston researchers cautioning that low-level red-light (LLRL) therapy can put the retina at risk of photochemical and thermal damage and is premature as a therapy.

Alleging several inaccuracies, Eyerising International said its device is misrepresented in the article. It does not ‘claim’ a Class 1 label but ‘has’ a Group 1 instrument classification indicating no potential light hazard exists, as defined by the ANSI Z80.36-2021 standard*. The authors also omitted that a Chinese patient who suffered rare adverse side effects fully recovered four months after the incident. 

One concern voiced by lead author Associate Professor Lisa Ostrin, from Houston University’s College of Optometry, is a lack of safety and efficacy standards for LLRL treatment for myopia. “We found that the red-light instruments for myopia exceed safety limits,” she wrote in the article, ‘Red light instruments for myopia exceed safety limits’ published in Ophthalmic & Physiological Optics (OPO). “For both LLRL devices evaluated here, three minutes of continuous viewing approached or surpassed the luminance dose MPE (maximum permissible exposure), putting the retina at risk of photochemical damage.”

Unlike the two devices tested in the study (Sky-n1201a and Future Vision), Eyerising’s device has already met quality, safety and efficacy standards as required by medical regulators in more than 30 countries across Europe and the Asia-Pacific, said Eyerising International in a statement. Further, the researchers didn’t use the latest American National Standards Institute standards required of ophthalmic instruments by the FDA in its study, it said. “They state in the article that they used the ANSI Z136.1 standard as the benchmark for their tests, acknowledging it was originally developed to protect individuals from accidental exposure to lasers in occupational situations. However, there is a more recent ANSI standard specifically developed for ophthalmic instruments. The ANSI Z80.36 standard specifies fundamental requirements for optical radiation safety for ophthalmic instruments, which the FDA required Eyerising to meet and which we obtained. “The researchers alleged possible risks associated with LLRL therapy based on their extremely limited laboratory testing of two devices but failed to mention that the Eyerising device has a proven safety record in both clinical trial and real-world settings,” Eyerising added.

Eyerising International has since penned a response to the article published by OPO online.

*The ANSI Z80.36-2021 standard is the FDA consensus standard for ophthalmic laser devices.