FDA approves IDE for Juvene IOL

Uday Devgan, MD

The future will bring truly accommodating IOLs for our cataract surgery patients so that we can effectively address the cataract, spherical refractive error, astigmatism and presbyopia at the same sitting.

The FDA recently approved an IDE for the Juvene IOL from LensGen, which means that a clinical trial in the U.S. is imminent and hopefully full FDA approval will be granted in the coming years once trial data are analyzed. While it is not possible to predict the outcome of this trial, I have considerable personal experience with using the Juvene IOL and its predecessors in clinical trials outside the U.S.

When I implanted the first Juvene IOL in 2015, we all realized that this was the beginning of a sea change in cataract surgery. The novel lens design, which fills the capsular bag, has changed the way that we think about replacement IOLs, with the new goal being to mimic a young physiologic crystalline lens and not simply to replace it with a fixed, unnaturally thin IOL.

Our future will undoubtedly bring multiple accommodating IOL designs so that surgeons can truly address presbyopia at the time of cataract surgery. The LensGen Juvene IOL is among the first of these designs to undergo an FDA trial, and we are excited to begin enrolling patients in the clinical trials.