Art Optical Contact Lens has received 510(k) clearance from the FDA on their Ampleye Scleral lens for the therapeutic management of ocular surface disease from dry eye.
The specific therapeutic indications for Ampleye include ocular pemphigoid, Stevens-Johnson syndrome, symblepharon formation, graft vs host disease, persistent epithelial defect, exposure keratitis, neurotrophic keratopathy (herpes simplex, herpes zoster, familial dysautonomia), Sjogren’s syndrome, filamentary keratitis, limbal stem cell deficiency, atopy, ectodermal dysplasia. The indication covers Ampleye lenses manufactured in roflufocon D, roflufocon E, hexafocon A, and for the first time, paflufocon D.
Ampleye became available just 18 months ago, but the lens has gained rapid acceptance. Hundreds of practitioners, from all 50 states as well as select international countries, have purchased diagnostic sets and successfully prescribed tens of thousands of Ampleye Rx lenses, according to a company news release.
The official indication for therapeutic use now granted by the FDA allows Art Optical to inform an even broader range of practitioners of the benefits of scleral lenses. According to Michael A. Johnson, FCLSA, Director of Consultation Services at Art Optical, in addition to using scleral lenses for the management of irregular cornea conditions, specialty contact lens fitters have routinely prescribed them for patients with dry eye issues as well.
“Dry eye disease is a growing condition that is presenting in virtually all practices,” Mr. Johnson said in the news release. “Art Optical’s FDA clearance for therapeutic use of Ampleye proves that it 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.”
The inclusion of a toric haptic periphery with all Ampleye diagnostic and Rx lenses provides a better match to the true shape of the sclera, resulting in predictable diagnostic fitting, improved Rx lens accuracy, and faster first fit success. “Ampleye’s advanced peripheral design also insures the soothing retention of the fluid between the cornea and the contact lens,” said Mr. Johnson. “Thanks to this latest approval, we look forward to helping many more dry eye sufferers.”
Ampleye lenses are competitively priced and available with front surface cylinder, quad-control, and multifocal features. Backed by Art Optical’s comprehensive warranty programs, Ampleye lenses are manufactured and shipped within 24 hours of order. For additional information, visit www.artoptical.com/ampleye, or contact Art Optical at 1-800-253-9364.