ROCHESTER, New York, USA, May 6, 2024 – Acuity Polymers, a leader in polymer science innovation for the development of specialty contact lens materials, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for expanded indications of its Acuity 200™ (fluoroxyfocon A) and Acuity 100™ (hexafocon A) daily wear gas permeable contact lenses, [510(k) Number K240618]. The newly granted FDA clearance includes the option of treating the contact lenses with Tangible® Hydra- PEG®.

“The expanded FDA 510(k) clearance of our leading Acuity 200 and Acuity 100 GP lens material products allows for more irregular corneal conditions to be addressed, especially for the increased number of patients suffering from dry eye issues” said Jim Bonafini, President of Acuity Polymers, Inc.

In addition to approved indications such as keratoconus, pellucid marginal degeneration, postrefractive surgery, post-keratoplasty surgery and more, specialty Eye Care Practitioners can now prescribe Acuity 200 and Acuity 100 gas permeable contact lenses to patients with ocular surface disease such as dry eye syndrome, Graft-versus-Host disease, Sjögren’s syndrome, and Filamentary Keratitis. Other approved indications include limbal stem cell deficiency, disorders of the skin, neurotrophic keratitis, and corneal exposure that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment.

For more information on the approved indications of Acuity 200, the world’s only Ultra Dk* GP contact lens material, and other Acuity GP contact lens material products, please visit https://www.acuitypolymers.com