US FDA Approves RxSight’s Light Adjustable Lens and Light Delivery Device

November 24, 2017: By Jon Swedien
RxSight's Light Adjustable Lens

RxSight’s Light Adjustable Lens

The US FDA has approved RxSight’s Light Adjustable Lens (RxLAL) and Light Delivery Device (LDD), the agency announced Nov. 22.

The RxSight IOL is made of a material that reacts to UV light, which is delivered using the LDD after surgery. It is the first system that can make small adjustments to an artificial lens’ power after cataract surgery so patients have better vision when not using glasses, the FDA said.

The device is intended for patients who have astigmatism in the cornea and no macular disease, the FDA said.

Residual refractive error, even after premium cataract surgery, is still common due to unpredictable wound healing, as well as variations in postoperative lens position. The RxLAL allows for in-office optimization after lens implantation and wound healing takes place, RxSight said.

The RxLAL is implanted like any standard foldable monofocal IOL, so there is no additional learning curve or time added to the procedure, RxSight said.

A surgeon can postoperatively expose the implanted lens to the frequency and amount of light needed to reshape the lens and achieve the desired vision, based upon patient feedback. Patients receive three or four light treatments, each lasting about 40 to 150 seconds. Then, the correction is locked in, the company said.

Patients must wear special eyeglasses for UV protection from the time of the cataract surgery to the end of the light treatments to protect the new lens from UV light in the environment, the FDA said.

In a clinical study of 600 patients evaluating the RxLAL and LDD, patients saw improvement of about one line for distance vision without glasses at six months compared with a conventional IOL, and 75 percent had a reduction in astigmatism, the FDA said.

The FDA said the device should not be used in patients taking systemic medication that may increase sensitivity to UV light such as tetracycline, doxycycline, psoralens, amiodarone, phenothiazines, chloroquine, hydrochlorothiazide, hypercin, ketoprofen, piroxicam, lomefloxacin and methoxsalen. Treatment in patients taking such medications may lead to irreversible eye damage. The device is also contraindicated in cases where patients have a history of ocular herpes simplex virus, the agency said.

Going forward, RxSight plans to focus on its postmarket study, additional indications, platform improvements, and building scalable infrastructure, said Eric Weinberg, the company’s COO.

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