Repeated low-level red-light (RLRL) device manufacturer Eyerising International says the reclassification of the emerging myopia management intervention in China is not indicative of safety or regulatory concerns of its device, and that it welcomes the increased oversight in China.
Further, the company said the change has no impact on use of the Eyerising device or regulatory approvals internationally.
The Australian-based manufacturer also clarified that it is a separate entity and commercial operation – selling the Eyerising device in all jurisdictions outside of China – from Suzhou Xuanjia Optoelectronics Technology, which sells the Eyerising device exclusively in China.
Although it claims this regulatory change does not affect Eyerising’s international operations, the company wants to address concerns from the international community regarding the China reclassification and clarify that the instrument can remain in use by its international users, as well as more than 110,000 daily users in China.
This statement is issued in response to a January 23 2025 opinion article in JAMA Ophthalmology discussing the recent reclassification of RLRL devices for myopia management to Class III in China.
In it, the authors from Tsinghua University Capital Medical University in Beijing, report that the reclassification would result in “more rigorous regulatory oversight” exclusively by the China National Medical Products Administration (NMPA), rather than as previously by provincial administrative departments without standardised requirements resulting in over 20 companies selling red-light devices in China.
In recent years, RLRL has emerged as a unique option for myopia management, exposing the retina to a red-light laser (635-650 nm) for a few minutes, typically twice a day, for five to seven days per week.
The Eyerising device is reported to be the only red-light device to have yet announced international regulatory approval, reporting commercial sales in Europe, Asia and Australia, having been approved by the Therapeutic Goods Administration in 2023.
Regarding regulatory changes in China, the authors said it would mean manufacturers need to conduct extensive safety studies, including trials on primates and long-term histopathological assessments, likely delaying further red-light therapy uptake in China.
Although reports suggest the effectiveness and safety of RLRL for up to 12-24 months, the authors said “debates persist within the ophthalmology community”.
“For instance, cases of macular damage have been observed after RLRL treatment, although the morphological damage has so far been reversible,” the authors stated.
Situation ‘unique’ to China
Eyerising International has responded offering “several clarifications on the regulatory status and standard practices of Eyerising International beyond what was discussed in the article”, particularly as it was the first to commercialise red-light devices outside of China.
“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 standardisation of requirements from both an efficacy and safety perspective,” the company said.
“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.”
However, the situation is unique to China, Eyerising International stated, 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 approvals internationally, it said, 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, Eyerising International’s statement said no significant adverse events have been observed.
“The single published case 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 eyecare 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 one, three, six months and every six months thereafter, and strongly recommend OCT at each of these appointments, to be reassured of continued safety.”
The company said it agreed with the authors that there was a crucial balance between advancing medical innovation and ensuring patient safety, and that it supported the efforts in China to standardise and improve 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,” it said.
“We remain committed to the continued efficacy and safety of our product, and continued safety monitoring practices as RLRL adoption increases in future.”
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