Cataract treatment company RxSight Inc reported on Wednesday 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.
According to the company, 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. Cataracts are the most common age-related eye condition and leading cause of preventable blindness.
This US FDA approval was based on the results from the company's randomized, US pivotal study comparing the Light Adjustable Lens to a commercially available monofocal lens in 600 patients with pre-existing astigmatism at 17 investigational sites.
The company said the 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.
Concurrently, the company's 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.
In addition, the company has received its CE mark for an expanded cylinder range (-0.5 to -3.00 diopters).
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