FDA grants Bausch + Lomb 510(k) approval for Boston XO, XO2 contact lenses
Friday, August 11, 2017
The FDA has granted 510(k) clearance to Bausch + Lomb for the therapeutic use of its Boston XO and Boston XO2 materials in treating several ocular surface diseases.
“The expanded indication enables scleral lenses manufactured with the Boston XO and Boston XO2 gas permeable materials to be utilized in the treatment of certain ocular surface conditions, including dry eye disease, which affects millions of people in the U.S., as well as limbal stem cell deficiencies, skin disorders with ocular surface manifestations, neurotrophic keratitis, corneal exposure that may benefit from the presence of an expanded tear reservoir and the saline-hydrated environment inherent in a scleral lens design,” according to the Bausch + Lomb release.
Boston XO (hexafocon A) contact lenses are indicated for daily wear to correct refractive ametropia in aphakic and non-aphakic patients with non-diseased eyes, according to the Indications for Use document.
The lenses may be prescribed in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration or following keratoplasty or refractive surgery.
Boston XO scleral lens designs for daily wear are indicated for therapeutic use for the management of irregular and distorted corneal surfaces.
Boston XO2 (hexafocon B) contact lenses are also indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia up to 5.00 D in non-diseased eyes.
Reference: accessdata.fda.gov, bausch.com