Visionary Optics Announces FDA Clearance for Entire Scleral Lens Product Line

ELMHURST, Ill.—Visionary Optics, maker of specialized contact lenses, has announced that the company has received a 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its complete line of scleral contact lenses (Jupiter, Europa, and Elara lenses).

“Historically, FDA clearance for scleral lenses has been based solely on lens material. It is a major milestone for Visionary Optics and the industry to now have multiple scleral lenses from multiple companies cleared based upon their individual designs and case reports documenting efficacy,” pointed out Donald R. Sanders, MD PhD, president and CEO of Visionary Optics. He added, “Each scleral lens company can now choose indications for use based upon what they can prove in terms of effectiveness with their own lens designs. Visionary Optics is pleased to have a broad range of indications for its scleral lenses.”

Visionary Optics’ scleral lenses for daily wear are indicated for the management of multiple ocular conditions, such as, degenerations that lead to an irregular corneal shape (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann’s Nodular Degeneration), dystrophies (e.g. Cogan’s dystrophy, Granular Corneal Dystrophy, Lattice Corneal Dystrophy,), post-surgery (e.g. corneal transplant, Lasik, radial keratotomy), and corneal scarring from infection or trauma, the company pointed out.

They are also indicated for therapeutic management of ocular surface disease including dry eye (e.g. ocular manifestations of Graft-versus-Host disease, Sjogren’s syndrome, dry eye syndrome), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical and thermal burns, radiation, filamentary keratitis), epidermal ocular disorders, disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment.

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