Light treatment company RxSight Inc reported on Thursday the receipt of approval from the US Food and Drug Administration (FDA) for the RxSight Light Adjustable Lens and the Light Delivery Device (LDD) for patients with pre-existing astigmatism of ≥ 0.75 diopters undergoing cataract surgery.

The company said its Light Adjustable Lens is the first and only US FDA approved intraocular lens (IOL) that can be adjusted post-operatively to improve uncorrected visual acuity, beginning of a new era in the treatment of cataracts. Light Adjustable Lens enables the physicians to make office-based refractive adjustments to the implanted lens after the cataract is removed and the eye is stable.

This US FDA approval was based on results from the company's randomised, pivotal US study comparing the Light Adjustable Lens to a commercially available monofocal lens in 600 patients with pre-existing astigmatism at 17 investigational sites. Patients receiving the Light Adjustable Lens, followed by light treatment with the LDD, achieved UCVA of 20/20 or better at six months postoperatively at approximately twice the rate of patients receiving a monofocal lens.

About 91.8% of Light Adjustable Lens patients achieved a result that was within 0.50 D of target manifest refraction spherical equivalent, which is similar to the refractive accuracy seen in recent LASIK studies. The approved device allows correction of up to 2 diopters of post-operative sphere and/or -0.75 to -2 diopters of residual postoperative refractive cylinder.

Cataracts, which occur when the eye's natural lens becomes clouded, are the most common age-related eye condition and leading cause of preventable blindness.