mitechnology


MacuMira Vision Gains for Dry AMD

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WRITER Michelle Hauschild

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A new microcurrent stimulation treatment is being rolled out across Australia, with early adopters finding that it is meaningfully improving vision in patients with dry age-related macular degeneration (dry AMD).

Australia is only the second country to approve the MacuMira device, which originated in Canada, where it is having a real impact. More than 20,000 treatments have been delivered to about 4,000 Canadian patients from approximately 200 clinical sites, with no major adverse safety effects.

While not a cure, MacuMira “is about improving visual function”, said Bhupinderpal Lotay, Head of Business Transformation from medical device company, Keeler. Keeler has partnered with MacuMira to manufacture the device and lead its distribution in Australia and New Zealand through ParagonCare.

“Other treatments target progression. This is targeting how patients actually see,” Mr Lotay said. “The patients who benefit most from MacuMira have dry AMD in the early to late stages (with no central geographic atrophy); these patients typically see positive response in terms of visual function, acuity, and contrast sensitivity.”

At the time of writing, seven Australian ophthalmologists – in Victoria (Melbourne), New South Wales (Sydney and Newcastle), Queensland (Bundaberg), and Western Australia (Perth) – had adopted the technology, with further expansion expected as clinicians gain experience and confidence.

PRESERVED RETINAL STRUCTURE

Two local ophthalmologists using the device have told mivision that their early results have been promising.

Dr Shanel Sharma, from Eye and Laser Surgeons in Sydney, said her initial scepticism has given way to cautious optimism. “In our clinic, there has been at least a one-line improvement,” she said.

Crucially, these improvements are translating into functional gains. “Two patients are now legal to drive who weren’t before… it’s given them independence back,” she said.

Dr Jessica Luzhansky, an ophthalmologist from 2020Now in Melbourne, has treated about a dozen patients and reports similar outcomes, with patient vision improving by one to two lines.

“Our very first patient came in and he said, ‘This is unbelievable’. He could see the tiny numbers, the dates on coins. He was very excited. He’s now just had his top-up treatment and he’s so happy – he’s reading a lot. So, it’s definitely helpful.”

WHAT IS MACUMIRA?

MacuMira uses low-level microcurrent stimulation, delivered via a headset, to stimulate the retinal pigment epithelium (RPE), enhancing mitochondrial activity to support cellular energy production and preserve or improve visual function in people living with dry AMD.

MacuMira President Justin Sather said “all patients in the clinical trial showed improvements in vision, with some patients gaining over two lines of vision”.1

“Our device is extremely safe, it is noninvasive, painless, and easily administered in an ophthalmologist’s office. We have seen no significant adverse effects in over 20,000 treatments in Canada.

“We look forward to improving the lives and visual function of the over 1.5 million Australians that suffer from dry age-related macular degeneration.

“I think our success in Canada will help pave the way in Australia. Although this is a new treatment in Australia, both doctors and patients can look to the success we’ve had in Canada and feel a sense of comfort in knowing how well the technology works. This is a simple but life changing treatment for patients with dry AMD.

“Patients suffering from this disease need to know there are options available to improve their vision,” Mr Sather said.

PATIENT REFERRALS

Because the device is so new to Australia, many patients with dry AMD who would benefit most from MacuMira are not being referred to ophthalmology.

“A lot of the patients with slightly reduced vision from dry AMD have previously been sent back to their optometrists for monitoring, as there were no treatment options,” said Dr Sharma.

“But they’re exactly the patients we now want to see – to try to improve their vision and quality of life. We need to be seeing these patients that we previously were discharging back to optometry, because we now have the injectables [Syfovre and Izervay, intravitreal injections recently approved for dry AMD] as well as MacuMira,” Dr Sharma said.

PATIENT PROFILE

For Dr Luzhansky and Dr Sharma, one of the major barriers to treatment is the cost, as MacuMira procedures are not yet subsidised or rebated in any way.

“It’s a very good adjuvant to have because there are lots of patients who have nothing else that we can offer. This is something that is non-invasive, it’s safe, and so far, on the the limited number of people that we’ve seen, it’s been very well tolerated and they have had improvements,” Dr Luzhansky said.

“Almost everyone has had some improvement in their acuity, in their clarity, in their contrast sensitivity… but I think the limiting factor for the majority of the patients will be cost. If it was free or if it was subsidised, I believe it would become very popular,” she said.

* For further information including full patient profile and contraindictions, contact ParagonCare: (AUS) 1800 225 307.

Reference

1. Parkinson KM, Sayre EC, Tobe SW. Evaluation of visual acuity in dry AMD patients after microcurrent electrical stimulation. Int J Retina Vitreous. 2023 Jun 18;9(1):36. doi: 10.1186/s40942-023-00471-y.

The Treatment Protocol

Potential candidates for MacuMira are those with best corrected visual acuity (BCVA) range 6/15–6/60 (20/50–20/200) using Early Treatment Diabetic Retinopathy Study charts; contrast sensitivity (with Pelli-Robson preferred or equivalent) ≥ 20 steps. Those with peripheral lesions respond better than those with central GA lesions, and foveal thickness is not correlated with treatment, according to MacuMira protocols. Contradictions include patients with pacemakers and epilepsy.*

The in-practice treatment protocol for MacuMira is a loading phase followed by ongoing maintenance.

“The loading phase consists of four treatments and each treatment lasts 32 minutes, and the patient needs to receive those four treatments within a 10-day period of time and no less than 12 hours between each treatment,” Keeler’s Mr Lotay explained.

“Then they need to conduct a maintenance phase. That consists of one treatment every two to three months.

“The patient sits down, the MacuMira headpiece is set up, and the eye cups and electrodes are placed comfortably. From there, they can relax with their eyes closed while the microcurrent treatment alternates between each eye during the 32minute session.”

Mr Lotay said most patients report that the treatment is relaxing. Some experience phosphenes, while others report a tingling sensation, which reduces significantly if the patient is well hydrated.

Patients complete a Quality-of-Life questionnaire at baseline, and repeat testing and questionnaires are required at the end of the loading phase and at maintenance visits.