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FDA clears Ampleye scleral lens

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The FDA has granted 510(k) clearance to the Ampleye Scleral lens for the management of ocular surface disease caused by dry eye, according to a press release from Art Optical Contact Lens.

Ampleye became available 18 months ago and has many therapeutic indications, including ocular pemphigoid, Stevens-Johnson syndrome, limbal cell deficiency and atopy.

The new indication from the FDA allows practitioners to benefit from scleral lenses to treat patients with dry eye.

“Dry eye disease is a growing condition that is presenting in virtually all practices,” Michael A. Johnson, FCLSA, director of consultation services at Art Optical, said in the release. “Art Optical’s FDA clearance for therapeutic use of Ampleye proves that is a safe and effective way to manage not only irregular corneas, but also the disruptive and often debilitating symptoms associated with ocular surface disease.”