A panel of FDA experts today was divided on whether the federal watchdog agency should approve the AcuFocus Kamra Inlay, a 1st-of-a-kind permanent corneal implant for the improvement of near and intermediate vision in patients with presbyopia, a form of age-related far-sightedness.
Of the 8 panelists 7 voted that Kamra is effective, the panel was evenly split on the question of safety, with the chairman breaking the tie and voting against. The panel was also divided on the question of whether the benefits outweigh the risks, with 4 panelists voting yes, 3 no and 1 abstaining. The chairman only votes to break ties.
The Kamra implant is placed under a corneal flap, where it reduces the aperture of the eye and increases the depth of focus to improve near vision. Kamra poses little or no risk to distance visual acuity and, unlike current surgical options, the Kamra device is removable and sustains its effect over time, according to AcuFocus.
There are currently no devices approved in the U.S. that are implanted in the cornea and intended to improve near and intermediate vision via a mechanism other than refractive correction, the FDA noted in background materials released ahead of the meeting.
Kamra has been on the market outside the U.S. since 2009, with approval in 50 countries, and AcuFocus estimates that nearly 20,000 KAMRA inlays have been implanted already. Of the people implanted with Kamra outside the U.S., the company has received 815 complaints, including 362 removals, 28 other secondary surgical interventions and 425 packaging complaints, the FDA noted.
People who have presbyopia but good distance vision are a challenging population to satisfy because they have no history of spectacle use and are resistant to using contact lenses or glasses. They’re also reluctant to compromise their distance vision for a gain in near vision, yet there is no current treatment available to satisfy both.
"A good surgical correction of presbyopia remains a significant unmet need," the company said in its presentation today before the FDA’s advisory panel.
Data for the Kamra has shown it consistently improves near vision by increasing depth of focus while maintaining distance vision and these results are sustained through 3 years of study, the company claims.
Some safety risks are associated with the implant, including persistent best corrected distance visual acuity loss of 0.6% at 12 months, though the majority of this is transient in nature, AcuFocus said. There was also a low rate of steroid-related intraocular pressure increases, decrease in monocular contrast sensitivity function within normal ranges, no change in binocular CS function from baseline, minimal increases in postoperative symptoms reported on patient reported outcomes, and early surgical endothelial cell density loss with minimal estimated long-term loss.
Further, data from the total study population "strongly support a favorable risk benefit profile," according to AcuFocus.
