Visian® Toric ICL Takes Next Step in FDA Approval Process with Favorable Advisory Panel Recommendation
We have great news for patients that have astigmatism and high levels of myopia (or nearsightedness) who may not currently be candidates for vision correction surgery with LASIK, PRK or the standard ICL. A recent vote by an advisory panel for the U.S. Food and Drug Administration (FDA) ruled in favor of recommending approval of the Visian® Toric Implantable Collamer Lens (TICL™). The Ophthalmic Devices Panel of the Medical Devices Advisory Committee is responsible for reviewing and evaluating investigational devices for use in the eye and making recommendations to the Commissioner of Food and Drugs. This advisory panel recently voted in favor of approval for the Visian® Toric ICL in various categories including safety, effectiveness, and benefits vs. risks. While this does not mean the Visian® Toric ICL is approved for commercial release, it is one step closer to being available for patients who have been waiting a long time.
Standard ICL surgery was originally approved by the FDA in 2005, and has been a great alternative vision correction surgery for people who suffer from high levels of myopia, thin corneas or dry eye. Unfortunately, the currently available standard ICL™ does not correct for astigmatism as well. Once approved, the Toric ICL from STAAR® Surgical will be able to offer patients with high levels of nearsightedness and astigmatism an option for surgical vision correction.
Ideal Candidates for the Visian® TICL:
- People between the ages of 21-45 years of age
- People with high levels of myopia (nearsightedness)
- People with between +1.0 to +6.0 diopters of astigmatism
- Patients with dry eye and thin corneas
- People wanting a reversible option for permanent vision correction
“ICLs have been a great benefit to our patients,” said Dr. Robert Cionni, Medical Director and ICL surgeon at The Eye Institute of Utah. “We are optimistic that we will soon be able to offer a surgical vision correction option with the Toric ICL for these patients with high levels of myopia and astigmatism.”
Although the advisory board voted in favor of approving the Visian Toric ICL, it could take up to 18 months for official FDA approval if they choose follow the Ophthalmic Devices Panel’s recommendation. At The Eye Institute of Utah, we are committed to keeping our patients up to date with the latest news regarding the availability of the Toric ICL and will release more detailed information regarding surgical dates upon pending official FDA approval. If you have questions regarding the status of the Toric ICL FDA Approval or would like to learn more about surgical vision correction surgeries, please contact us at 801-760-4171.