The Food and Drug Administration (FDA) has approved the IC-8® Apthera™ Intraocular Lens (IOL) for the treatment of cataracts.
The Apthera IOL is indicated for unilateral implantation for the visual correction of aphakia and to create monovision in patients 22 years of age or older who have been diagnosed with bilateral operable cataract, who have up to 1.5 diopters (D) of corneal astigmatism in the implanted eye, and who do not have a history of retinal disease and who are not predisposed to experiencing retinal disease in the future.
The Apthera IOL is the first small aperture wavefront-filtering intraocular lens with an embedded FilterRing™ component that delivers focused light to the retina, while filtering out peripheral defocused light. Compared with an aspheric monofocal or monofocal toric IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity.
The device is intended for primary implantation in the capsular bag, in the nondominant eye, after the fellow eye has already undergone successful implantation (uncorrected distance visual acuity 20/32 or better and best-corrected distance visual acuity 20/25 or better) of a monofocal or monofocal toric IOL that is targeted for emmetropia.
The approval was based on data from a US Investigational Device Exemption study (ClinicalTrials.gov Identifier: NCT03633695) that evaluated the efficacy and safety of Apthera IOL implanted in 1 eye and a monofocal or monofocal toric IOL implanted in the fellow eye. The study included 453 patients aged 22 years and older with bilateral cataracts who require cataract surgery. The outcomes of the Apthera IOL arm (n=343) were compared with a control group (n=110) receiving a monofocal or monofocal toric IOL in both eyes.
Findings demonstrated that the Apthera IOL-treated eyes maintained 2 D of extended depth of focus and achieved 0.91 D of additional range of vision benefit compared with the monofocal IOL eyes at 0.2 logMAR threshold, which exceeded the 0.50 D ANSI criterion.
Moreover, patients in the Apthera IOL arm achieved equivalent uncorrected distance vision and statistically superior intermediate and near vision compared with patients in the control arm. There was also comparable binocular contrast sensitivity observed in both photopic and mesopic conditions in the Apthera IOL and control arms.
“We are delighted to receive FDA approval for our first-of-its-kind Apthera IOL,” said Al Waterhouse, president and chief executive officer for AcuFocus. “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 nontoric IOL indicated for cataract patients with low amounts of corneal astigmatism.”
According to the Company, a limited release of the Apthera IOL will begin in the fall of 2022.
Apthera IOL is contraindicated for use in patients with dilated pupil sizes less than 7.0mm and patients with a history of retinal disease including but not limited to, high myopia, diabetes, macular disease, sickle cell disease, retinal tear, retinal detachment, retinal vein occlusion, ocular tumor, uveitis, and patients who are predisposed to experiencing retinal disease in the future.
- AcuFocus announces FDA approval for the IC-8® Apthera™ Intraocular Lens, the first and only small aperture lens for cataract surgery. News release. AcuFocus, Inc. Accessed July 25, 2022. https://www.businesswire.com/news/home/20220725005273/en/AcuFocus-Announces-FDA-Approval-for-the-IC-8%C2%AE-Apthera%E2%84%A2-Intraocular-Lens-the-First-and-Only-Small-Aperture-Lens-for-Cataract-Surgery
- Our technology. AcuFocus. Accessed July 25, 2022. https://acufocus.com/our-technology/