AcuFocus’ Small Aperture IC-8 Apthera IOL Earns FDA Nod

Ophthalmic device firm AcuFocus has earned U.S. Food and Drug Administration (FDA) approval for its breakthrough IC-8 Apthera intraocular lens (IOL) for cataracts.
 
The non-toric, extended depth of focus IOL is the first of its kind, approved for the 82% of cataract patients with as much as 1.5 diopters (D) of corneal astigmatism.
 
“We are delighted to receive FDA approval for our first-of-its-kind Apthera IOL,” Al Waterhouse, president and CEO of AcuFocus told the press. “The Apthera IOL represents several firsts for surgeons and patients: the first small aperture IOL to receive FDA approval, the first lens indicated for implantation with a monofocal or monofocal toric IOL in the fellow eye, the first extended depth of focus lens indicated for monovision, and the first non-toric IOL indicated for cataract patients with low amounts of corneal astigmatism.”
 
Most patients get a monofocal IOL at the time of cataract surgery. While monofocal lenses provide excellent distance vision, objects up close remain blurry. Other available presbyopia-correcting lens designs have complex optics that split, shift, or stretch light to provide clear vision at more than one discrete focal point.
 
In contrast, the Apthera IOL, with proprietary small aperture technology, provides excellent distance vision as well as clear intermediate and near vision, mitigating the effects of presbyopia.
 
“The Apthera IOL is the first lens design, with its embedded FilterRing component, to mitigate the effects of presbyopia by simply filtering out peripheral defocused and aberrated light that degrades image quality. This allows central focused light to be delivered to the retina,” said Vance Thompson, MD of Vance Thompson Vision. “This novel mechanism of action provides patients with continuous range of vision from far through intermediate and near, even if they have as much as 1.5 D of corneal astigmatism.”
 
FDA approval was based on AcuFocus’ U.S. IDE study comparing Apthera to a monofocal or monofocal toric IOL. Apthera IOL treated eyes maintained 2 D of extended depth of focus and demonstrated 0.91 D of additional range of vision benefit over monofocal IOL eyes at 0.2 logMAR threshold, exceeding the 0.50 D ANSI criterion for extended depth of focus IOLs. Apthera IOL subjects achieved equivalent uncorrected distance vision and statistically superior intermediate and near vision compared to control subjects. Apthera IOL subjects also achieved comparable binocular contrast sensitivity to control subjects in both photopic and mesopic conditions, a first reported for an extended depth of focus lens.
 
The company aims to begin limited commercial launch of Apthera IOL in the U.S. this fall.