Contamac received FDA premarket approval of Optimum Infinite material

Contamac announces FDA Premarket approval (PMA) of Optimum Infinite (tisilfocon A) material for use in orthokeratology overnight wear.

Contamac, a global leader in specialty contact lens and intraocular lens materials today announced U.S. Food and Drug Administration (FDA) Premarket approval for the Optimum Infinite (tisilfocon A) Orthokeratology Lenses II.

Outside the USA, this approval in one of the leading global ortho-k markets will provide extra support to Contamac’s lens manufacturing partners as they market their lenses with additional oxygen transmissibility, to support corneal health.

Indications for Use

The Optimum Infinite (tisilfocon A) Orthokeratology Lenses II for overnight wear are indicated for use in the reduction of refractive error in non-diseased eyes. The lenses are indicated for overnight wear for the temporary reduction of myopia up to 6.00 diopters with eyes having astigmatism up to 1.75 diopters. When worn overnight and removed upon waking on a prescribed schedule, orthokeratology lenses provide a temporary reduction in myopia during all or most of one’s waking hours.

Clinical and Material Advantages

With its exceptionally high oxygen permeability (180 Dk), Optimum Infinite helps to maintain corneal oxygenation – an important factor for corneal health during overnight wear.

Correct up to 6.00 diopters of myopia and 1.75 diopters of astigmatism.

The material’s optimized balance of mechanical strength, dimensional stability, and surface performance enables precision manufacturing and consistent lens performance.

Commitment to Speciality Innovation

“FDA approval of our Optimum Infinite (tisilfocon A) material represents a significant milestone for Contamac and for specialty lens practitioners,” said Robert McGregor, Managing Director.  “We are incredibly proud to achieve FDA Premarket approval for the Optimum Infinite (tisilfocon A) material for orthokeratology. This PMA approval reinforces our commitment to advancing high-oxygen GP materials in support of clinicians delivering innovative orthokeratology and vision correction  solutions.”

The PMA approval gives lens manufacturers throughout the world independent endorsement of the safety and efficacy of hyper Dk Optimum Infinite (tisilfocon A) materials in ortho-k designs for overnight wear, further expanding high Dk options for practitioners and patients. Eye care practitioners should contact their preferred contact lens manufacturer for further details.