Johnson & Johnson Vision announced the FDA approval and US launch of Tecnis Toric II 1-Piece IOL. This is the first product approved on the new Tecnis Toric II platform, which offers more surface texture and friction on the IOL haptics to hold an IOL in proper position within the eye, according to Johnson & Johnson Vision.
The company is launching two post-market clinical trials to demonstrate the rotational stability and visual outcomes offered by the Tecnis Toric II platform. The trials will be conducted at up to 50 sites across the U.S. to collect qualitative and quantitative measures with up to 1,000 patients.
“Today’s patients with cataracts not only want clear vision, but also less dependence on glasses following surgery—something that has historically been challenging to deliver for those with astigmatism,” Daniel H. Chang, MD, Cataract and Refractive Surgeon at Empire Eye & Laser Center, said in a company news release. “In my experience, toric IOLs can produce excellent visual outcomes, however, even small misalignments of the lens can lead to blurred vision. I’m looking forward to being part of the post-market clinical trials to further evaluate the rotational stability of Tecnis Toric II IOL in a large population of patients.”
Toric IOLs are the most predictable method for correction of astigmatism, however surgeon concerns around rotational stability may be acting as a barrier to providing treatment, according to Johnson & Johnson Vision. Properly implanting a toric IOL can be more challenging than a conventional spherical IOL due to the high degree of precision required to align the lens properly in order to correct the astigmatism present in the eye.4 Movement of the lens after implantation can result in decreased vision and the need for realignment.
“With the launch of Tecnis Toric II IOL, our goal is to provide surgeons with a higher degree of confidence in treating astigmatism so that more cataract patients can enjoy clear, high quality vision,” Xiao-Yu Song, Global Head of Research & Development, Johnson & Johnson Vision, said in the news release. “This advance represents the latest addition to our Tecnis family of IOLs, building on our proud history of raising the standard of care for patients with cataracts.”