FDA relaxes clinical trial guidelines, opens U.S opportunity to Visioneering

Medtech developer Visioneering Technologies (ASX: VTI) may soon have its NaturalVue Multifocal (NVMF) contact lenses re-classified by the FDA which has just approved the first contact lenses which slow the progression of nearsightedness. 

The FDA approval was given to CooperVision’s MiSight® 1 day contact lens which slows the progression of myopia specifically in children. The condition naturally worsens progressively before stabilising in adulthood. 

The approval may be a sign of things to come with Visioneering Technologies having achieved similar results for their NaturalVue Multifocal (NVMF) contact lenses which have been approved in Europe, Australia, New Zealand, Hong Kong, and Singapore.

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

“This achievement may establish a pathway to FDA approval specifically for myopia progression control in the U.S. for other innovators like Visioneering. We estimate that the addressable market for myopia progression in the U.S. is approximately US$2 billion.” 

In the U.S., NVMF is already adopted by optical practitioners for the correction of myopia which it has been granted FDA approval for, but not specifically for myopia progression control. Peer reviewed data, however, has confirmed the progression of myopia in children by over 90% where the approval of MiSight opens a regulatory approval path for NVMF to be re-classified. 

In the United States, myopia affects 1 in 3 children where onset is also correlated with other ocular diseases whilst the World Health Organisation has cited under-correction as the most common cause of visual impairment globally. 

Shares in Visioneering Technologies surged to reach a high of $0.075 per share in early morning trade, a rise of 25% from their previous day’s close of $0.06.