Canadian medical device company MacuMira Medical Devices has achieved a significant regulatory milestone with the launch of the first Health Canada-approved treatment designed to improve visual function for patients with dry age-related macular degeneration (AMD). The MacuMira system represents a breakthrough for a patient population that has historically faced limited therapeutic options.
Revolutionary Non-Invasive Technology
The MacuMira system delivers low-dose microcurrent stimulation through closed eyelids during 32-minute treatment sessions. This non-invasive approach is now available in more than 150 clinics across Canada, making it widely accessible to patients with dry AMD.
"This represents a turning point in care for patients with dry AMD," said Justin Sather, CEO of MacuMira Medical Devices. "Losing your driver's license, struggling to read, or not being able to apply makeup or recognize your grandchildren are daily realities for many Canadians with this disease."
Mechanism of Action and Clinical Evidence
The MacuMira system works by stimulating retinal cells, which improves mitochondrial function, reduces inflammation, and increases ATP production. These cellular improvements translate into measurable clinical benefits for patients.
A randomized controlled trial published in the International Journal of Retina and Vitreous reported significant improvements in visual acuity and contrast sensitivity following treatment with the MacuMira system. The clinical evidence supporting the device's efficacy has contributed to its regulatory approval and widespread adoption.
Treatment Adoption and Clinical Impact
More than 15,000 treatments have already been delivered across Canada, demonstrating rapid uptake of this novel therapeutic approach. The substantial treatment volume reflects both physician confidence in the technology and patient demand for effective dry AMD interventions.
"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," commented Dr. Amit Gupta, ophthalmologist and retina specialist at Clarity Eye Institute in Toronto.
Broader Canadian Ophthalmology Landscape
The MacuMira approval is part of a series of significant regulatory developments in Canadian ophthalmology. In July, Health Canada approved Alcon's Clareon Panoptix Pro IOL for cataract patients, utilizing proprietary ENLIGHTEN NXT Optical technology that delivers the lowest light scatter and highest reported light utilization of any trifocal IOL.
The same month saw approval of Eylea's Aflivu (aflibercept) for various retinal diseases, marking the Canadian-based global health company's first ophthalmic biosimilar. August brought additional market developments, including an agreement between Lupin and Sandoz Group AG for marketing biosimilar ranibizumab across multiple regions, and public funding approval for Roche Canada's Vabysmo (faricimab injection) for macular edema secondary to retinal vein occlusion on Quebec's RAMQ medication list.
