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Cataract/Anterior Segment
IOL Insertion/Toric IOLs

FDA approves IC-8 Apthera intraocular lens for treatment of cataracts

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The US Food and Drug Administration (FDA) has approved the IC-8 Apthera intraocular lens (AcuFocus, Inc) for the treatment of cataracts. This is the first and only non-toric extended depth of focus intraocular lens (IOL) approved for patients who have as much as 1.5 diopters (D) of corneal astigmatism.

Approval was based on data from the U.S. Investigational Device Exemption study in which patients (n = 343) had Apthera IOL implants in one eye and a monofocal or monofocal toric IOL implanted in the fellow eye. Patients in the control group (n = 110) received a monofocal or monofocal toric IOL in both eyes. Patients were followed for 1 year.

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 patients achieved equivalent uncorrected distance vision and statistically superior intermediate and near vision compared to control subjects. Apthera IOL patients 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.

“As one of the clinical investigators for the Apthera IOL, I saw firsthand how the unique optics work, and I can’t wait to add it to my practice,” said Elizabeth Yeu, MD of Virginia Eye Consultants, Norfolk, Virginia in a press release. “The Apthera IOL is unlike any lens we have had before. I believe it will fill a significant gap in our IOL armamentarium allowing every cataract surgeon to meaningfully expand their treatment options for patients.”

Read the full press release here.

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