If a company can attract investment from the likes of Medtronic and Bausch + Lomb its technology must be a serious prospect. AcuFocus is gearing up for US approval of its Kamra device, and as this is designed to treat farsightedness a shortage of sufferers will not be a problem.
But Kamra, which will be assessed by the FDA’s ophthalmic devices panel on June 6, is a corneal implant and it is debatable how many patients will volunteer for a procedure that can be treated with a pair of spectacles. While the panel will not concern itself with this, it will surely examine Kamra’s safety most carefully.
The Kamra inlay is an opaque ring-shaped device that is permanently implanted in front of the iris, in a corneal pocket or flap created using an optical laser. It reduces the aperture of the eye, thereby improving vision by providing an increased depth of focus in the implanted eye. This is similar to the principle on which pinhole cameras work.
The ring is made from a biocompatible polymer called Kynar, and the aperture in its centre is 1.6mm in diameter. The device is implanted in only one of a patient’s eyes, usually the non-dominant one, at around 180 micrometres beneath the surface of the eye. While it improves near vision, it does not have any negative impact on distance vision, AcuFocus says, though Kamra can be removed if necessary and the patient’s vision returns to its pre-surgical levels.
While this sounds like a drastic solution to a common problem most sufferers deal with by simply wearing glasses, it should be remembered that the global market for laser eye surgery, much of which is elective, is estimated to reach $800m next year.
Kamra is CE marked and was launched in Europe in 2010, and is also sold in Japan, Canada and Mexico. As ever, though, the US market is the crucial nut to crack if AcuFocus is to reap the kind of revenues its funders will want.
In 2011 the company raised $65m in a series F round led by Cowen Healthcare Royalty Partners. Other participants included its prior backers Medtronic, Bausch + Lomb, Accuitive Medical Ventures, Versant Ventures, SV Life Sciences and the Carlyle Group.
There is a rival product in the offing: the Raindrop device under development by ReVision Optics. Raindrop’s pivotal US trial is underway, but with a completion date of May 2015 according to clinicaltrials.gov the product will not be ready for submission to the FDA for a year or more. AcuFocus will need a positive panel vote to have a hope of carving a niche in the US market before its sales are dampened by Raindrop.