AcuFocus Completes Study Enrollment for U.S. IDE Clinical Trial of IC-8 Lens
AcuFocus announced that it has completed enrollment in its pivotal US investigational device exemption (IDE) study of the company’s IC-8 small aperture IOL.
FDA granted approval of the company’s IDE on November 21, 2018, and the Investigational Review Board approved the study just 5 hours later, according to AcuFocus. With the first patient being enrolled 13 days after the approval, the IC-8 IOL treatment arm of the study was enrolled in 6 months and the full study enrollment was completed in just over 7 months.
“Typically, a study like this would take up to 12 months to fully enroll, which is a testament to both the high-quality investigational team and the excitement for this lens technology,” Al Waterhouse, AcuFocus President and Chief Executive Officer, said in a company news release. “The study is on track with our projected timeline, which puts us on pace for potential US market entry around Q4 2020/Q1 2021.”
A first-of-its-kind technology for cataract patients, the AcuFocus IC-8 IOL is a clear monofocal lens with an embedded mini-ring or pinhole in the center. This proprietary lens design is intended to increase a patient’s natural range of vision by extending the focus of light rays that enter the eye.
“Running a successful clinical trial depends on all participants—from the sponsor to the investigational sites—taking their role seriously and executing with high standards and focus,” Magda Michna, PhD, AcuFocus Chief Global Clinical and Regulatory Affairs Officer, said in the news release. “I couldn’t be more pleased with the team and their efforts to meet the aggressive enrollment challenge we set forth.”
The 12-month prospective, multicenter, non-randomized case control clinical trial will evaluate the improvement in vision achieved at all distances with the IC-8 IOL when compared with traditional monofocal IOLs. Bilateral cataract patients assigned to the study group received contralateral implantation with an IC-8 IOL and a monofocal, or monofocal toric IOL, and those assigned to the control group received bilateral monofocal or monofocal toric IOLs.
“The IC-8 IOL is a real advancement in the field of IOL optics. My team and I have been hearing from my international colleagues about their results with the lens for a couple years now and we are just delighted with our experience to date,” Vance Thompson, MD, a clinical investigator for the trial and director of refractive surgery for Vance Thompson Vision in Sioux Falls, South Dakota, said in the news release. “Being a part of the team to evaluate this lens in the United States is truly an honor.”