The KAMRA small-aperture corneal inlay from AcuFocus was approved by the FDA in April 2015 for the treatment of presbyopia, and the company began a controlled commercial launch in June. Nicholas Tarantino, OD, chief clinical and regulatory officer of AcuFocus, said that the US rollout has exceeded every internal company metric. During the first year in the US, over 2,000 inlays have been implanted, and over 80% of implanting surgeons have reordered, typically within one month. The heavy focus on surgeon training has resulted in excellent clinical outcomes since launch, with mean uncorrected distance and near visual acuity of 20/25 and J2, respectively. Refractive practices that have advertised the KAMRA inlay have also experienced over 20% average growth in LASIK and premium IOLs, demonstrating a significant pull-through effect from marketing a presbyopia solution.
AcuFocus has also incorporated its small-aperture technology into the IC-8 presbyopia-correcting IOL, which has been under investigation in Europe and is entering a commercial launch phase. The IC-8 IOL provides extended depth-of-focus while maintaining high image quality and avoiding the glare and halos typically associated with multifocal IOLs. The small-aperture optic is also capable of correcting up to 1.50 D of astigmatism, potentially addressing over 80% of cataract patients, without the need for a toric IOL or astigmatism-correcting corneal incisions.
Nicholas Tarantino, OD
Nick Tarantino, OD is Chief Clinical and Regulatory Officer and Head of R&D for AcuFocus, Inc., a company specializing in innovative solutions for the treatment of presbyopia.