FDA approves cornea-altering device to correct near vision

Raindrop Near Vision Inlay--Courtesy of ReVision Optics

The FDA has approved a device implanted in the cornea to correct near vision in some patients with presbyopia, or farsightedness caused by decreased elasticity of the eye's lens.

The Raindrop Near Vision Inlay, manufactured by ReVision Optics, is the first implant that improves vision by changing the shape of the cornea and the second corneal implant to improve near vision in people who have not had cataract surgery. It is a clear device made of hydrogel, like a tiny contact lens, and is implanted in one eye. It is indicated for patients aged 41 to 65 who cannot focus on near objects and need reading glasses, but not glasses to correct farsightedness.

It works by giving the eye a steeper surface to help it focus on near objects or print, thereby changing the curvature of the cornea and correcting near vision. The lens of a normal eye focuses by changing its shape, but patients with presbyopia have hardened and inelastic lenses, which don't focus well on near objects. The device is implanted in a patient's nondominant eye via a flap the surgeon cuts in the cornea, the FDA said. Some patients may need a second surgery to remove or replace the implant.

A 373-patient clinical trial showed that after two years, 92% of patients included in the analysis could see near objects with 20/40 vision or better in the inlay-implanted eye, the FDA said in a statement. However, the implant can cause or aggravate pain, glare, halos and the sensation of having a foreign object in the eye. It can also cause dry eye and detachment of the retina as well as worsen distance vision.

Presbyopia affects almost all adults as they age, representing a large and continuous market of potential patients. The condition is currently corrected with reading glasses or bifocals, in the case of people who need to correct their distance vision as well as near vision. Corneal inlay surgery is an alternative for people who do not wish to wear glasses, the FDA said in a statement.

ReVision Optics' backers include Johnson & Johnson ($JNJ), Canaan Partners, Russia's Rusnanomedinvest and Domain Associates, which all participated in a $55 million financing round back in 2013. At the time, ReVision inked a commercial supply and distribution deal with NovaMedica, a joint partnership including both Domain Associates and Rusnano, which intends to bring Raindrop into Russia and surrounding countries.

- here's the statement

Special Report: FierceMedicalDevices' 2013 Fierce 15 - ReVision Optics