MacuMira launches first Health Canada-approved device for AMD treatment

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Canadian medical device company MacuMira Medical Devices recently introduced the first Health Canada-approved treatment to improve visual function for patients with dry age-related macular degeneration (AMD).¹

This new technology, the MacuMira system, is a non-invasive treatment now available in more than 150 clinics across Canada. In 32-minute sessions, the MacuMira system delivers low-dose microcurrent stimulation through closed eyelids.

“This represents a turning point in care for patients with dry AMD,” Justin Sather, CEO of MacuMira Medical Devices, said in a press release. “Losing your driver’s licence, struggling to read, or not being able to apply makeup or recognise your grandchildren are daily realities for many Canadians with this disease.”

Through stimulating retinal cells, the MacuMire system improves mitochondrial function, reduces inflammation and increases ATP production. More than 15,000 treatments have already been delivered in Canada to date, and a randomised controlled trial published in the International Journal of Retina and Vitreous reported significant improvements in visual acuity and contrast sensitivity, MacuMira said in a press release.

“It’s encouraging to see that new technologies are being developed and offered to patients in Canada with dry age-related macular degeneration who previously had little hope for treatment,” Dr Amit Gupta, ophthalmologist and retina specialist at Clarity Eye Institute in Toronto, commented.

Other approvals in Canada

This approval follows a busy summer of approvals in Canada.

In July, Alcon’s Clareon Panoptix Pro IOL was approved for Canadian patients with cataracts.² The IOL utilises the company’s proprietary ENLIGHTEN NXT Optical technology, which delivers the lowest light scatter and highest reported light utilisation of any trifocal IOL, Ophthalmology Times Europe previously reported.²

Health Canada also approved Eylea’s Aflivu (aflibercept) for the treatment of various retinal diseases in July.³ According to previous reporting, this approval marked the Canadian-based global health company’s first ophthalmic biosimilar.

August also brought marking rights and funding updates. Lupin and Sandoz Group AG have entered into an agreement in which Sandoz will market and commercialize Lupin’s biosimilar ranibizumab across multiple regions.⁴ While Hoffmann-La Roche Limited (Roche Canada) announced that Vabysmo (faricimab injection) is now publicly funded for macular oedema secondary to retinal vein occlusion (RVO) on the Régie de l’assurance maladie du Québec (RAMQ) list of medications.⁵

Reference:

1. MacuMira Medical Devices Inc. Health Canada Approves MacuMira Retinal Microcurrent Stimulation Device to Improve Vision for Dry AMD Patients Nationally. Newswire.ca. Published September 22, 2025. Accessed September 23, 2025. https://www.newswire.ca/news-releases/health-canada-approves-macumira-retinal-microcurrent-stimulation-device-to-improve-vision-for-dry-amd-patients-nationally-805427441.html

2. Joy J. Clareon Panoptix Pro IOL (Alcon) approved in Canada. Ophthalmology Times. Published July 9, 2025. Accessed September 23, 2025. https://europe.ophthalmologytimes.com/view/clareon-panoptix-pro-iol-alcon-approved-in-canada

3. Crago SM. Health Canada approves aflibercept biosimilar Aflivu. Ophthalmology Times. Published July 10, 2025. Accessed September 23, 2025. https://europe.ophthalmologytimes.com/view/health-canada-approves-aflibercept-biosimilar-aflivu

4. Harp MD. Sandoz will license Lupin’s ranibizumab biosimilar in Europe, other select regions. Ophthalmology Times. Published August 12, 2025. Accessed September 23, 2025. https://europe.ophthalmologytimes.com/view/sandoz-license-lupin-ranibizumab-lucentis-biosimilar-europe-asia-emea-lubt010

5. Harp MD. Québec announces faricimab (Vabysmo, Roche) will be funded for macular oedema secondary to RVO. Ophthalmology Times. Published August 19, 2025. Accessed September 23, 2025. https://europe.ophthalmologytimes.com/view/qu-bec-announces-faricimab-injection-vabysmo-roche-will-be-funded-for-macular-oedema-secondary-to-rvo