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Accommodative IOL gets FDA panel nod

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GAITHERSBURG, Md. – An IOL designed to provide accommodation last week received recommendation for approval with conditions from a government advisory panel, according to C&C Vision, the IOL’s marketer.

With the recommendation of the Food and Drug Administration’s Ophthalmic Devices Panel, C&C Vision’s CrystaLens is now on track to become the first IOL with lens accommodation as a mechanism of action to receive U.S. marketing approval. The lens is designed to move forward and backward with ciliary muscle movements caused by patient efforts to focus.

C&C Vision is seeking approval for the lens “for primary implantation in the capsular bag for the correction of aphakia in an adult in whom a cataractous lens has been removed and who may benefit from improved near, intermediate and distance vision without spectacles,” according to the panel’s meeting summary.

The panel recommended the lens as approvable with conditions. The panel listed five points as its conditional approval, including stratifying data by pupil size. The remaining conditions are to be addressed on the labeling, according to the panel summary, including determining the accommodative amplitude and that 20/40 acuity was higher in bilaterally implanted patients than in primary eyes. Additionally, the panel noted that C&C Vision did not provide in vivo data for long-term stability of the lens hinge. The panel also recommended that the labeling should note that the data does not cover patients younger than age 50 and that patients may still require glasses for some activities.

The panel’s decision was based on data from a 497-eye study conducted at 12 U.S. and three international sites. Data included information on 324 primary eyes and 173 fellow eyes, with a mean patient age of 70. One-year follow-up data showed that 100% of bilaterally implanted eyes had near, intermediate and distance visual acuity of 20/40 or better.

“We are very pleased that the [panel] has unanimously recommended approval of the CrystaLens Accommodating IOL,” J. Stuart Cumming, MD, FACS, FRCOphth, developer of the lens, told Ocular Surgery News. “For me this is the culmination of 14 years of research. Upon final approval, hopefully later this year, it will give me great pleasure to see patients in the U.S. have access to the CrystaLens and lead a life with minimal need for glasses."