A response to your 3 Feb post regarding red-light therapy for myopia

Dear Editor of the Salud Equitativa blog, On the 3rd of February you reposted an article from STAT News about red-light therapy for the treatment of myopia. My client is the manufacturer of the only red-light therapy device to be licensed and approved for the treatment of myopia in mor than 30 countries around the world. As such we would appreciate an opportunity to rebut some of the inaccurate statements made by Dr. Ostrin in that article. I hope you will consider posting our letter of response below. Dear Editor, Eyerising International would appreciate an opportunity to respond to, and rebut certain claims made in, an article you posted on 3rf February under the headline, “Promising red-light myopia treatment for children is raising safety concerns among experts Annalisa Merelli By Annalisa Merelli Feb. 2, 2024” The piece was reporting on an article recently published in the Ophthalmic & Physiological Optics (OPO) Journal, titled, “Red light instruments for myopia exceed safety limits”, which was authored by Lisa A. Ostrin and Alexander W. Schill. Eyerising International has spoken to the Editor-in-Chief of the OPO Journal, and he has agreed to give the company the right of reply to Dr Ostrin’s article and to publish a letter to the editor addressing several of the inaccuracies and misrepresentations in Dr Ostrin’s OPO article. As the originator of repeat low-level, red light therapy (RLRL) sometimes also called LLRL (low level red light therapy) and the manufacturer of the only red-light myopia management device licensed and approved for the treatment of myopia in multiple countries, Eyerising International would like to address some inaccuracies Dr Ostrin repeated in your article. Point 1 In the press release, based on only testing two copycat devices in her laboratory Dr Ostrin generalises to all red light devices: “The safety profiles of red-light laser devices for myopia have not been fully investigated,” The Eyerising device has been very fully investigated, it has undergone 10 clinical trials and four (4) real world studies, covering 1785 patients, with a cumulative clinical trial use of 9.25 years - with zero significant adverse events recorded. The device has been used to treat more than 160,000 patients in the real world over the past eight years, and there are currently more than 80,000 daily users. To date, there have only been five (5) cases of significant adverse side effects reported; with no permanent damage recorded. Point 2 In the press release Dr Ostrin said: “Based on measurements in our laboratory, it is recommended that clinicians strongly reconsider the use of LLRL therapy for myopia in children until safety standards can be confirmed,” Numerous countries have established such safety standards and unlike the two copycat devices Dr Ostrin tested in her laboratory the Eyerising device meets the quality, safety, and efficacy standards required by medical regulators in over 30 countries across Europe and APAC, with several more pending. 1. Eyerising International is ISO 13485:2016 certified by notified body BSI. 2. CE mark as Class IIa medical device 3. MHRA approved Class IIa in UK 4. MedSafe Class IIa in New Zealand 5. TMMDA approved Class IIa in Turkey 6. Australian Register of Therapeutic Goods (ARTG) in Australia 7. Medical Device Authority (MDA) in Malaysia Point 3 Testing to the wrong standards Dr Ostrin and her colleague stated in the original OPO article that they tested two devices to the ANSI Z136.1 standard as the benchmark for their tests. Although they acknowledged that the ANSI Z136.1 standards were developed to protect individuals from accidental exposure to lasers in occupational situations, they did not mention that there is a more recent ANSI standard specifically for ophthalmic instruments. The ANSI Z80.36 standard specifies fundamental requirements for optical radiation safety for ophthalmic instruments. It applies to all ophthalmic instruments (including current, new, and emerging instruments) that direct optical radiation into, or at the eye. It also applies to those parts of therapeutic or surgical systems that direct optical radiation into, or at the eye for diagnostic, illumination, measurement, imaging, or alignment purposes [2]. It is the ANSI Z80.36-2021 standard, which the FDA required Eyerising to meet and which we obtained. Point 4 In the article you ran Dr Ostrin said: “The company behind one of the devices reports that it is already being used to address myopia in over 100,000 pediatric patients.” As Eyerising International is the only company with an approved product this can only refer to us, although it fails to mention that the Eyerising device has a proven safety record in both clinical trial and real-world settings. The Eyerising device has to be prescribed by an Eye Health professional such as an ophthalmologist or optometrist. It has been used to treat more than 160,000 patients with only five (5) cases of significant adverse side effects reported. Eyerising International is not just the leading player in the field of LLRL but the only player in the field with a red light device licensed and approved by regulatory authorities in multiple countries for the treatment of myopia. Despite that obvious qualification Dr Ostrin never tested our device and never even requested one of our devices to test. Had she done so we would have been happy to supply one as we have every confidence in its safety record. Despite never testing our device Dr Ostrin referred to it inaccurately several time in her OPO article and by implication by generalising her comments to cover all red light devices for treating myopia, although she only tested two. In conclusion: Eyerising International takes our responsibility for ensuring the safety and efficacy of our RLRL therapy device seriously. We remain committed to working closely with healthcare professionals and users to collect and investigate any adverse reactions and to address any potential concerns. Apart from our extensive and on-going clinical trials we always consult the relevant authorities when entering new markets to ensure that our device meets any and all safety standards required by the relevant authorities. About Eyerising International Eyerising International is an Australian MedTech company developing life-impacting eye-health therapy to slow the progression of myopia. We are led by a team of world-renowned ophthalmology academics, researchers and a board with a proven track record in MedTech innovation, implementation, and clinical facilitation. Eyerising International’s patented Myopia Management Repeated Low-Level Red–Light (RLRL) therapy was conceived and developed by ERI’s Chief Medical Officer, Professor Mingguang He, a global leader in myopia control and the development of artificial intelligence systems in ophthalmology. This innovation in childhood myopia control meets the quality, safety, and efficacy standards required by medical regulators in over 30 countries across Europe and Australasia. Issued by: Eyerising International Pty Ltd 2.05 9/11 Claremont St, South Yarra VIC 3141, Australia PR@eyerisinginternational.com References: Lisa A. Ostrin and Alexander W. Schill. “Red light instruments for myopia exceed safety limits”, OPO January 2024. ANSI Z80.36-2016 Tian Yu, Xiao Zhigang, Recovery of retinal structural damage after repeated low-intensity red light therapy for high myopia: a case report, CMA.J.CN, August 2023 - https://rs.yiigle.com/cmaid/1471399 John Battersby Senior Regional Account Director Bridges M&C Pte Ltd (HQ) | 176 Joo Chiat Road #04-01 Singapore 427447 D: +65 6345 1783 | M: +65 9754 1092 | E: john@bridges-comms.com