Health: FDA approval is eye candy for Visioneering’s kiddie contact lens
Health & Biotech
Health & Biotech
Link copied to
A company that wants to save Asia’s kids from short sightedness, is seeing a way to work the same magic on American children.
Visioneering (ASX:VTI) only has US Federal Drug Administration (FDA) approval for its contact lens as a myopia treatment, not as a way to control the condition’s progression.
But US company CooperVision does, as of last week.
The FDA approved its MiSight single use, disposable, soft contact lens specifically to control myopia progression in children, a first in the US.
What Visioneering is hoping is that this may herald a relaxation of the FDA’s clinical trial rules for myopia progression which the company said were “prohibitive”.
The data CooperVision submitted to the FDA was from a prospective clinical trial at four clinical sites and real-world evidence.
“The safety and effectiveness of MiSight was studied in a three-year randomised, controlled clinical trial of 135 children ages eight to 12 at the start of treatment who used MiSight or a conventional soft contact lens,” the FDA said on Friday.
“The trial showed that for the full three-year period, the progression in myopia of those wearing MiSight lenses was less than those wearing conventional soft contact lenses. In addition, subjects who used MiSight had less change in the axial length of the eyeball at each annual checkup.”
Visioneering chief Dr Stephen Snowdy says the FDA had originally been asking for a minimum three year study, a washout period of six months to a year where the children would stop wearing the lens but also no other corrective lenses, and a safety trial to prove that contact lenses in children were as safe as for adults, that Visioneering estimated would require 700 patients.
“CooperVision has got the FDA to concede that contact lenses are as safe in children as in adults, that brings the number of patients required in that study to about 130, which is much more doable,” he told Stockhead. “They also got the FDA to accept that there was no real need to do a washout and it just wasn’t practical to do that.”
Myopia occurs when light beams entering the eye converge in front of the retina (conversely, long sightedness is when they focus behind the retina), because the whole eyeball is too long.
But regular lenses make the light rays converge on the retina, in effect lengthening the focus, but don’t do the same for peripheral light. The eyeball keeps lengthening to compensate for that light, the myopia keeps getting worse.
Visioneering and CooperVision, among others, are developing lenses that block out peripheral light and prevent extra eyeball lengthening.
Visioneering has been contacted for comment.
The US is Visioneering’s main market and the company is allowed to sell in Australia and New Zealand, but recent approvals to sell its lens as myopia progression control in Hong Kong and Singapore means the company is finally moving on a long held Asia strategy.
Up to 96 per cent of school leavers in South Korea have myopia, according to research by professor Ian Morgan of Australian National University. In China it’s 80 per cent and in Singapore 82 per cent.
By comparison, 20 per cent of Australian school leavers are shortsighted.
The cause, scientists now know, is a combination of ‘near work’ — reading books, looking at computers and so forth — and a lack of time outdoors.
Morgans analyst Scott Power says Visioneering is a promising company with a good product with permission to sell in Europe, Australia, New Zealand, Hong Kong, and Singapore, but noted they’ve “had some funding issues”.
He says these were resolved with two cap raises in 2018 and this year totalling $29.3m.
With just under $5m in the bank and the quarterly cash take ticking up ever so slowly, from $1m in December to $1.7m in September, it’s likely the company will need to tap the market again.
“[At a $24m market cap] they’re a small player in a big market and they’re making good progress,” he told Stockhead.
Snowdy says they’ve been open with shareholders about the fact that they’ll need to raise money money.
Getting to positive cashflow partly depends on getting into China, where they have to run a separate set of clinical trials to convince the China Drug Administration. Snowdy says this has been delayed by the US-China trade spat.
Wattle Health (ASX:WHA) has disappointed investors again, extending its suspension further to December 16. And why? It’s worried shareholders not only won’t pony up with $55m and will also reject a company-changing deal to buy a stake in dairy processing company Blend & Pack. The deal was first announced in February and Wattle has so far failed to secure the cash it needs to do the deal.
Actinogen (ASX:ACW), the Alzheimer’s aspirant which failed spectacularly at Alzheimers has been asked what is going on with its share price, which is back up to where it was before its clinical trial came up short, at 5.7c. The company is all innocence, saying it has no idea.
Antisense (ASX:ANP), the biotech trying to cure a horrific genetic disorder affecting mainly young boys called Duchenne muscular dystrophy (DMD), says it’s finished treating the nine patients in the phase two clinical trial and data should be in by the end of the year.