FDA approves hydrogel inlay for presbyopia

The Raindrop corneal inlay (ReVision Optics) is now approved for the treatment of emmetropic presbyopia. 

Smaller than the eye of a needle, the clear hydrogel inlay is implanted in the nondominant eye under a corneal flap created by a femtosecond laser. It is designed to create a profocal cornea by gently steepening the central cornea, creating a smooth gradient of power. A surgical video on the ONE Network shows how to insert the device.

Results from a phase 3 clinical study published in the March 2016 issue of Ophthalmology shows that the inlay can provide a range of uninterrupted vision.

• Average uncorrected near visual acuity improved by 5 lines
• No loss of binocular distance vision
• 93% of subjects achieved UNVA of 20/25 or better in the treated eye
• Mean uncorrected visual acuity for both eyes exceeded 20/20 at all distances with no loss in contrast sensitivity
• 92% rate of satisfaction at 1 year postop

Clinical investigator, Dr. John Hovanesian, discusses the inlay further in this video interview. The device is indicated for use in cataract patients, aged 41 to 65 years, with +1.50 to +2.50 D of presbyopia.

The Raindrop near vision inlay is not recommended for patients with severe dry eye, active eye infection or inflammation, keratoconus, abnormal corneal features, certain autoimmune or connective tissue diseases, insufficient corneal thickness, recent herpes infection, uncontrolled glaucoma or uncontrolled diabetes.

ReVision expects the device to be widely available by the third quarter of 2016.