FDA Nods Approval to First Implanted Lens to Enhance Patienta's Vision

The U.S. Food and Drug Administration (FDA) gave an approval to RxSight Inc. Light Adjustable Lens and Light Delivery Device on November 22. It became the first medical system that makes minute adjustments in the power of artificial lens after the surgery to provide better vision to patients without using glasses.

Cataract is a common eye problem, in which person’s vision is impaired as natural lens become clouded. The natural lens which became cloudy is removed and replaced with artificial lens in a cataract surgery. However, many patients suffer from minor residual refractive error after the surgery. Then they are required to wear glasses or contact lenses.

“Until now, refractive errors that are common following cataract surgery could only be corrected with glasses, contact lenses or refractive surgery,” said Malvina Eydelman, M.D., Director of the Division of Ophthalmic, and Ear, Nose and Throat at the Center for Devices and Radiological Health of FDA. “This system provides a new option for certain patients that allows the physician to make small adjustments to the implanted lens during several in-office procedures after the initial surgery to improve visual acuity without glasses.”

The RxSight IOL is manufactured using a unique material which responds to UV light. The Light Delivery Device delivers the device after 17–21 days of surgery. Based on the amount of adjustment required, there are three or four light treatments given to patients over a period of 1–2 weeks. Each treatment lasts for about 40–150 seconds.

However, it is mandatory for patients to wear special eyeglasses for UV protection from the beginning of the cataract surgery to the end of the light treatments. It serves the purpose of protection of the new lens from UV light.

The efficacy and safety of the RxSight Light Adjustable Lens and Light Delivery Device was tested in a clinical study conducted on 600 patients. The results with the RxSight IOL and a conventional IOL were compared. Patients experienced an improvement of at least one additional line down the vision chart six months after the procedure. Moreover, 75 percent of patients experienced reduction in astigmatism. The device is targets for patients with astigmatism (in the cornea) before surgery and who are not suffering from macular diseases.

In its recent report on the global ophthalmic drugs market, Big Market Research states that the market was valued at $29,613 million in 2016, and is estimated to reach $42,663 million by 2023, growing at a CAGR of 5.3% from 2017 to 2023. The report provides insights on current market trends, detailed segmentation, and key manufacturers to offer competitive outlook on the industry.

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