FDA approvals

FDA approves Kamra inlay implant for presbyopia

AcuFocus has received FDA approval for the Kamra inlay for surgical correction of near vision in presbyopic patients, according to a company release.

“The Kamra inlay is the number one implanted corneal inlay globally,” Jim Mazzo, chairman and CEO of AcuFocus, said in the release. “After a decade of research, development and clinical investigation, we are delighted to bring this innovative technology to surgeons and patients in the U.S.”

The Kamra inlay is an opaque, ring-shaped device implanted in the cornea of the patient’s nondominant eye in order to extend depth-of-focus for those who have not had cataract surgery and have emmetropic refraction, the release said.

The device blocks unfocused light rays entering the eye and peripheral light rays while allowing central light rays to pass through a small opening in the center of the device, an FDA release said.

The FDA approval was based on results from a 5-year clinical study of 508 patients who experienced an average improvement in uncorrected near visual acuity of 20/40 or better during a 12-month follow-up. Compared to other presbyopia procedures, mean preoperative uncorrected distance visual acuity in the inlay-implanted eye was maintained during follow-up, the release said.

Kamra inlay is commercially available in 50 countries worldwide, with the US approval representing the first major advancement in surgical correction of presbyopia in over a decade, the release said.

AcuFocus has received FDA approval for the Kamra inlay for surgical correction of near vision in presbyopic patients, according to a company release.

“The Kamra inlay is the number one implanted corneal inlay globally,” Jim Mazzo, chairman and CEO of AcuFocus, said in the release. “After a decade of research, development and clinical investigation, we are delighted to bring this innovative technology to surgeons and patients in the U.S.”

The Kamra inlay is an opaque, ring-shaped device implanted in the cornea of the patient’s nondominant eye in order to extend depth-of-focus for those who have not had cataract surgery and have emmetropic refraction, the release said.

The device blocks unfocused light rays entering the eye and peripheral light rays while allowing central light rays to pass through a small opening in the center of the device, an FDA release said.

The FDA approval was based on results from a 5-year clinical study of 508 patients who experienced an average improvement in uncorrected near visual acuity of 20/40 or better during a 12-month follow-up. Compared to other presbyopia procedures, mean preoperative uncorrected distance visual acuity in the inlay-implanted eye was maintained during follow-up, the release said.

Kamra inlay is commercially available in 50 countries worldwide, with the US approval representing the first major advancement in surgical correction of presbyopia in over a decade, the release said.