FDA approves EVO Visian lens

On March 25, the FDA added a tool to the refractive surgeon’s tool belt with the approval of STAAR Surgical’s EVO ICL. This is a welcomed development for U.S. surgeons whose patients would like access to the technology as well as for surgeons worldwide who count FDA approval as further validation of its safety and efficacy.

The first posterior chamber collagen copolymer Visian ICLs were implanted in 1993, nearly 3 decades ago. These lenses required creating a peripheral iridectomy either preoperatively with a YAG laser or surgically during the ICL implantation. FDA trials for the spherical and toric ICL began in the late 1990s and led to FDA approval of the spherical Visian ICL V4 in December 2005. This ICL V4 is the ICL presently implanted in the United States as of this writing in March 2022.

Around the time of FDA approval in 2005, researchers began to study placing a 0.36-mm hole in the center of the ICL V4 optic so as to obviate the need for peripheral iridectomy. The first patients received this ICL V4c in 2011. Shortly thereafter, surgeons globally moved on to implant the EVO ICL in a single step rather than the previous V4 that required two procedures (peripheral iridectomy and implantation).

After a decade of widespread use of the EVO globally, and following an excess of 1 million implants worldwide, the EVO ICL has received FDA approval. To say that this day has been long awaited in our surgeon community would be an understatement.

Within the coming weeks, all U.S. ICL implants will switch to EVO. Patients can look forward to a comfortable 10-minute procedure, rapid visual recovery, minimal induction of dry eye and a lens-based corrective option that preserves corneal tissue for the future. U.S. surgeons look forward to a simple process without peripheral iridectomy and without the low but present cataract risk associated with the previous V4.

After notching two FDA ICL approvals in 4 years, the future looks bright for expansion of the EVO dioptric range (beyond –3 D to –20 D), the age range (beyond 21 to 45 years) and the addition of presbyopia-correcting optics. A final hope and pleading would come from our young hyperopes who represent a small percent of our patients but nonetheless have substantial need for a phakic IOL option. These patients come to us with stromal neovascularization, giant papillary conjunctivitis and contact lens intolerance. They are often unable to wear thick and/or heavy spectacles for a variety of personal and even professional reasons. Given the limits of glasses, contacts and LASIK for this small but needy slice of our population, my hope for them would be U.S. availability of the hyperopic ICL that our international colleagues have implanted globally for more than 20 years.

References:

Packer M. Clin Ophthalmol. 2016;doi:10.2147/OPTH.S111620.

Shimizu K, et al. Br J Ophthalmol. 2012;doi:10.1136/bjophthalmol-2011-300148.

The U.S. approval of the EVO Visian lens takes away an important barrier to surgeons and patients adopting ICL technology — the need for a peripheral iridotomy. A small opening in the center of the implant, which does not affect its optics, allows free flow of aqueous around the crystalline lens and into the anterior chamber without altering iris anatomy. This removes a previous step of surgery that had its own risks and complications. It moves the ICL a step closer to LASIK in terms of simplicity.