Visioneering Technologies eyes US myopia market after FDA approval for industry peer

Eye care company Visioneering Technologies (ASX: VTI) is celebrating this morning after an industry competitor received a key approval from the US Food and Drug Administration (FDA) for its CooperVision’s MiSight contact lens – the first approved contact lens that slows the progression of near-sightedness in children.

The reason for the celebratory mood is that the approval could spell an expedited path for Visioneering’s own NaturalVue multifocal contact lenses that are already approved in Europe, Australia, New Zealand, Hong Kong and Singapore.

With CooperVision receiving the key approval that allows its product to be marketed across the US, Visioneering is hopeful it will soon have the same ability.

Headquartered in the US, Visioneering designs, manufactures, sells and distributes contact lenses but is actively expanding its portfolio of technologies to address a range of eye care issues with a primary focus on myopia.

According to Visioneering Technologies, the approval represents a major step forward for the field of myopia progression control and demonstrates the rapidly emerging interest in the US for new products that treat myopia progression.

Near-sightedness growing rapidly

Market research places the addressable market for myopia progression in the US is approximately US$2 billion per year.

Myopia is one of the most common eye disorders in the world with prevalence ranging from 30%-40% among adults in Western countries to as high as 80%+ in several East Asian countries. According to some estimates, roughly half of the world’s population will be near-sighted by the year 2050.

Visioneering explained that the FDA approval could also be an indicator of a relaxation of clinical trial guidelines that could see further FDA applications – and possibly expedited approvals – in the near term. Seeing an industry peer being approved has therefore given the company a confidence boost regarding its own product.

“The approach used to gain US clearance of MiSight may indicate a relaxation of some clinical trial guidelines that previously had been suggested by the FDA but were prohibitive to the execution of efficient clinical trials in myopia progression,” the company said.

Visioneering declared that it is already considering the next steps in how to pursue a specific claim for myopia progression control for its NaturalVue Multifocal (NVMF) contact lenses in the US.

NaturalVue multifocal lenses are approved for the correction of myopia in the US, but not specifically for myopia progression control.

However, many eye care professionals in the country are already using NaturalVue for treating myopia progression as it employs a unique optical design, shown to slow the progression of myopia in children by over 90%.

In addition to its product being adapted to treat myopia progression and being fully approved by regulators, Visioneering claims that its NaturalVue product could be even more effective than CooperVision’s MiSight.

MiSight is available in distance powers up to -6.00 diopters while NaturalVue is available in a full range of distance powers up to -12.25 diopters, enabling treatment of a greater portion of the myopic population than MiSight, the company said.

“The US approval of MiSight is very positive for Visioneering and the industry, and an exciting time for practitioners of myopia progression in the US,” said Visioneering Technologies chief executive officer Dr Stephen Snowdy.

“This achievement may establish a pathway to FDA approval specifically for myopia progression control in the US for other innovators like Visioneering. This FDA announcement should help to highlight the need for myopia progression control, and therefore benefit patients, practitioners and innovators,” he added.

Despite the FDA approval for an industry rival, this morning’s news boosted Visioneering Technologies shares by over 21% up to $0.073 per share.