Red Light Therapy Device Manufacturer Welcomes China’s Stricter Red Light Therapy Reclassification for Myopia

China has raised the regulatory bar for red light therapy in myopia—and a leading manufacturer of the devices seems to be (mostly) all for it. Here’s why.

A leading manufacturer of repeated low-level red light (RLRL) devices for myopia has fired back in the escalating controversy over the technology and its safety profile.

Eyerising International (Melbourne, Australia), a leading manufacturer of RLRL devices has issued a statement in response to a recent opinion piece in JAMA Ophthalmology, where high-profile names like Tsinghua University’s Prof. Tien Yin Wong surveyed the technology’s current situation in China and its potential implications.¹

A regulatory shift in China last year has reclassified repeated low-level red-light (RLRL) devices for myopia management from Class II to Class III, marking a significant tightening of oversight for this emerging therapy.

In the statement, Eyerising mostly welcomed the changes while offering clarifications it felt were necessary to give the full picture of a rapidly evolving landscape for RLRL therapy in myopia.

A video illustrating how repeated low-level red light therapy works in managing myopia.

The full text of the statement is given below, courtesy of Eyerising International:

A Response to ‘Red Light Therapy for Myopia – Current Regulatory Changes in China

A viewpoint article has recently been published in JAMA Ophthalmology concerning the reclassification of repeated low-level red-light (RLRL) devices for myopia management to Class III in China.¹As the Australian manufacturer of the Eyerising RLRL device, which is the only device to have obtained international regulatory approvals outside of China, we would like to offer several clarifications on the regulatory status and standard practices of Eyerising International beyond what was discussed in the article. Of note, Eyerising International is a separate entity and commercial operation from Suzhou Xuanjia Optoelectronics Technology, which manufactures and sells the Eyerising device in China.

First and foremost, we acknowledge and duly welcome the need for appropriate regulatory oversight into RLRL as a novel therapy for myopia management. As the authors pointed out, the previous Class II classification of red-light devices in China meant that regulatory approvals were mandated on a provincial administrative level with no standardization of requirements from both an efficacy and safety perspective. This resulted in over 20 RLRL devices being approved with varying degrees of clinical evidence, some of these without any published clinical studies proving their effect. In contrast, the Eyerising device in China is backed by a robust body of clinical trials and evidence, making it one of the most thoroughly supported devices in this category.

This situation is unique to China, as other countries and the European Union regulate medical devices on a national or regional level. Unlike other RLRL devices in China, the Eyerising device has received Class IIa/Class B regulatory approval internationally, based on strong evidence of its efficacy and safety. These approvals were granted independently and are not dependent on China’s NMPA. Therefore, the recent reclassification in China to Class III does not affect the Eyerising device. Going forward, the Eyerising device’s supporting evidence will be submitted for national NMPA review in China by Suzhou Xuanjia Optoelectronics Technology, as Eyerising International has done in other markets.

Furthermore, the reclassification does not constitute a product recall within China. Existing users of RLRL devices in China are allowed to continue using the device, and all devices manufactured before 1 July 2024 are allowed to be sold. As a result, the Eyerising device remains in use by over 110,000 daily users in China. Despite rigorous monitoring for complications by the NMPA, no significant adverse events have been observed. The single case report of reversible changes mentioned in this article was also submitted as part of both Suzhou Xuanjia Optoelectronics Technology’s and Eyerising International’s ongoing post-market surveillance.

Finally, we at Eyerising International would like to highlight the safety precautions and stringent monitoring we have implemented in all international use of the Eyerising device as a newer myopia control treatment. The Eyerising device is only available through an eye care professional (e.g. optometrist, ophthalmologist) that has been appropriately trained on RLRL, and has never been made available without physician oversight. We also require regular follow-up of all patients using the Eyerising device at 1, 3, 6 months and every 6 months thereafter, and strongly recommend OCT at each of these appointments, to be reassured of continued safety.

We agree with the authors that there is a crucial balance between advancing medical innovation and ensuring patient safety, and we support the efforts in China to standardize and improve their regulatory oversight into RLRL. However, we would like to clarify that the reclassification in China does not reflect safety or regulatory concerns on the part of the Eyerising device or Eyerising International. We remain committed to the continued efficacy and safety of our product, and continued safety monitoring practices as RLRL adoption increases in future.