FDA panel affirms Kamra inlay’s efficacy and benefits, votes 'no' on safety

Issue: July 10, 2014

GAITHERSBURG, Md. — Amid concerns about safety and study methodology, the U.S. Food and Drug Administration’s Ophthalmic Devices Panel of the Medical Devices Advisory Committee voted June 6 on three questions concerning the Kamra inlay.

Perspective from Robert P. Rivera, MD

Although more panel members voted “no” on a question of the device’s safety, a majority voted “yes” on efficacy and a slim majority voted “yes” on whether the device’s benefits outweigh the risks.

The Kamra inlay (AcuFocus) is indicated for the improvement of near and intermediate vision in presbyopic patients. The inlay is placed intrastromally in the cornea on the visual axis through a femtosecond laser-created pocket using a spot/line separation of 6 x 6 µ or less. Placement of the inlay should be at a depth of 180 µ or greater.

“The Kamra inlay represents more than a decade of research, development and clinical evaluation, and we appreciated the opportunity to present the Kamra data back to the Ophthalmic Devices Advisory Panel,” Nick Tarantino, MD, Chief Clinical and Regulatory Officer for AcuFocus, said in a company press release.

On the question of the implant’s safety in patients who meet the criteria specified in the proposed indication, four members voted yes and five voted no. Panel chairman Neil M. Bressler, MD, cast a vote to break a 4-4 tie; the chairman does not normally vote.

On the question of the implant’s effectiveness in patients who meet the criteria specified in the proposed indication, seven members voted yes and one voted no.

On the question of whether the benefits outweigh the risks of using the inlay as indicated, four members voted yes, three voted no and one abstained.

“While I had concerns about some of the methodologies and missing data, I still felt there was adequate evidence to support the ‘yes’ votes for those three,” temporary voting member Janine A. Clayton, MD, said.

The Kamra inlay received CE Mark approval in the European Union in 2005.

Perspective

Robert P. Rivera, MD

The recent U.S. Food and Drug Administration Ophthalmic Device Panel meeting held in Gaithersburg, Md., made important industry news with its review of the AcuFocus Kamra corneal inlay. A first-in-kind device for the treatment of presbyopia, the Kamra surprisingly received a mixed vote. Being a surgeon with first-hand experience implanting the Kamra, and myself a patient, having received the inlay in my non-dominant eye nearly 3 years ago, I offered my perspective during the open public hearing section.

At day's end, the panel voted in the affirmative as to the questions of efficacy and the benefits outweighing the risks. But the first vote as to the safety, with the chairman's tie-breaking vote giving it a "no," clearly was a frustration in the minds of industry — not only for AcuFocus, but for all corneal inlay innovators who have taken on the challenge of surgical presbyopia management.

I believe the FDA and AcuFocus both recognize the need to better address the safety questions posed. Hindsight suggests a better mechanism for reporting the safe outcomes of the small percentage of patients in whom the device was explanted would have helped, rather than simply exiting them from the study. A better background and understanding of refractive surgery from the non-refractive surgeon panel members would have helped. And in the interest of fairness to both the public and industry, a more equitable selection of the non-voting, but nonetheless quite vocal, consumer and patient "advocates" would have eliminated what seemed to so many of us to be a negative bias and distrust of all things surgical. Despite any confusion as to the nature of the votes, however, I feel technology will win — it has already addressed my own presbyopia with remarkable results.

Robert P. Rivera, MD

Director of Clinical Research

Disclosures: Rivera is a consultant to AcuFocus and an investigator for Presbia.