FDA has approved the KAMRA inlay, a device implanted in the cornea of one eye to improve near vision in certain patients with presbyopia. Presbyopia is the loss of the ability to change the focusing power of the eye and it is estimated that by the year 2020, nearly 2.1 billion people world-wide will be experiencing presbyopia.
The KAMRA inlay is an opaque, ring-shaped device intended for patients 45-60 years old who have not had cataract surgery. These patients are unable to focus clearly on near objects or small print and need reading glasses with +1.00 to+2.50 diopters of power but do not need glasses or contacts for clear distance vision.
The device blocks unfocused light rays entering the eye in order to improve near vision. It blocks peripheral light rays while allowing central light rays to pass through a small opening in the center of the device, making near objects and small print less blurry.
To insert the device, an eye surgeon uses a laser to create a pocket in the cornea of one eye and then implants the device in that pocket. This is intended to allow the patient to have improved near vision in the eye containing the implant, while not affecting the distance vision of both eyes working together.
The KAMRA inlay is manufactured by AcuFocus Inc. www.acufocus.com based in Irvine California. Last September, the company announced the completion of $21 million in funding. The financing was oversubscribed and all existing AcuFocus investors participated including HealthCare Royalty Partners www.healthcareroyalty.com, SV Life Sciences www.svisa.com, Versant Ventures www.versantventjures.com, Carlyle Group www.carlyle.com, Accuitive Medical Ventures www.amvpartners.com, and Medtronic www.medtronic.com.
More than 20,000 KAMRA inlays have been implanted and commercially approved in over 50 countries worldwide. Since the device has received FDA approval, the company is expanding their sales and marketing efforts.
AcuFocus has also developed a presbyopia correcting intraocular lens called AcuTarget HD using the small aperture effect and is appropriate for patients undergoing cataract surgery or refractive lens exchange.
The AcuTarget HD was developed in collaboration with Visiometrics www.visiometrics.com. It combines five diagnostic tools into one state-of-the-art instrument to provide clinicians with objective data to support patient selection and post-operative management. AcuTarget HD actually lets doctors see what the patient is seeing and enables the depth of focus and visual quality to be measured.