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FDA panel recommends premarket approval application for AcrySof IQ ReSTOR multifocal toric IOL

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GAITHERSBURG, Md. — In an overwhelming panel vote, the U.S. Food and Drug Administration Ophthalmic Devices Panel of the Medical Devices Advisory Committee voted to recommend Alcon’s premarket approval application for the AcrySof IQ ReSTOR +3.0 D multifocal toric IOL.

The 12-member panel voted a unanimous “yes” on two questions: whether there is reasonable assurance that the AcrySof IQ ReSTOR multifocal toric posterior chamber IOL is safe for use in patients who meet the criteria specified in the proposed indication and whether there is reasonable assurance that the lens is effective for use in patients who meet those criteria.

With one “no” vote and 11 “yes” votes, the panel decided the benefits of the IOL outweigh the risks for use in patients who meet the criteria specified in the proposed indication.

The proposed indication for the combination IOL is for “primary implantation for the visual correction of aphakia and preexisting astigmatism secondary to removal of a cataractous lens in adult patients with and without presbyopia who desire near, intermediate and distance vision, reduction of residual refractive cylinder and increased spectacle independence,” according to Alcon’s application. The multifocal toric IOL combines optical properties of a +3 D multifocal IOL with those of a toric IOL and would be placed in the capsular bag.

Panel member Bennie H. Jeng, MD, MS, said, “Despite a little bit of controversy about the patient subjective outcomes, I think the objective data was compelling.”

Panel members had debated whether deficiencies in the sponsor’s data submitted as patient-reported outcomes (PROs) would limit the usefulness of assessing “spectacle independence.”

The lone dissenting vote was given by Susan Vitale, PhD, MHS, whose concerns related to the deficiencies in the PROs. She said, “The reason I voted ‘no’ on question 2 is because of my concerns about the claim of increased spectacle independence. … All the other evidence was quite convincing, but I don’t feel quite comfortable with saying ‘yes’ when it includes the increased spectacle independence as one of the outcomes.”

Disclosures: Jeng and Vitale have no relevant financial disclosures.