Irvine, California-based AcuFocus said in a news release that the Apthera IOL represents the first and only non-toric, extended depth of focus IOL approved for the 82% of cataract patients who have 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,” AcuFocus President and CEO Al Waterhouse said in the release. “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.”
With proprietary small aperture technology, Apthera provides excellent distance vision as well as clear intermediate and near vision to mitigate the effects of presbyopia, according to AcuFocus.
FDA approval comes on the back of data from AcuFocus’ FDA investigational device exemption (IDE) study that evaluated the safety and effectiveness of the Apthera IOL implanted in one eye and a monofocal or monofocal toric IOL implanted in the fellow eye.
The study evaluated 453 subjects, following them for 12 months. Outcomes for the 343 patients in the Apthera group were compared to 110 in the control group, which received a monofocal or monofocal toric IOL in both eyes. 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 intends to start a limited commercial release of Apthera in the U.S. in the fall of this year.
“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 Dr. Vance Thompson of Vance Thompson Vision in Sioux Falls, South Dakota. “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.”