Aurous HealthCare

USFDA approves first intraocular lens for cataract patients

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The U.S. Food and Drug Administration approved the first intraocular lens (IOL) that provides cataract patients with an extended depth-of-focus, which helps improve their sharpness of vision (visual acuity) at near, intermediate and far distances.

Cataracts are a common eye condition where the natural lens becomes clouded, impairing a patient’s vision. According to the National Eye Institute, more than 20 percent of Americans will have cataracts by the age of 65, and the prevalence increases with age. In cataract surgery, the clouded natural lens is removed and replaced with an IOL.

“While IOLs have been the mainstay of cataract treatment for many years, we continue to see advances in the technology,” said Malvina Eydelman, M.D., director of the Division of Ophthalmic and Ear, Nose and Throat Devices in the FDA’s Center for Devices and Radiological Health. “The Tecnis Symfony Extended Range of Vision IOL provides a new option for patients that may result in better vision across a broader range of distances.”

Traditional monofocal IOLs have been limited to improving distance vision. The Tecnis Symfony IOL improves visual acuity at close, intermediate and far ranges and, therefore, may reduce the need for patients to wear contact lenses or glasses after cataract surgery.

The approval is based on a review of results from a randomized clinical trial comparing 148 cataract patients implanted with the Tecnis Symfony IOL to 151 cataract patients implanted with a monofocal IOL. The study evaluated visual acuity at near, intermediate and far ranges; contrast sensitivity (the ability to distinguish small differences between light and dark); and adverse events for six months after implantation. Of the patients implanted with the Tecnis Symfony IOL, 77 percent had good vision (20/25), without glasses at intermediate distances, compared to 34 percent of those with the monofocal IOL. For near distances, patients with the Tecnis Symfony IOL were able to read two additional, progressively smaller lines on a standard eye chart than those with the monofocal IOL. Both sets of patients had comparable results for good distance vision.

Patients implanted with the Tecnis Symfony IOL may experience worsening of or blurred vision, bleeding or infection. The device may cause reduced contrast sensitivity that becomes worse under poor visibility conditions such as dim light or fog. Some patients may experience visual halos, glare or starbursts. The device is not intended for use on patients who have had previous trauma to their eye.

The Tecnis Symfony IOL is also available in four toric models, which are indicated for the reduction of residual refractive astigmatism or imperfections in the curvature of the eye.

The Tecnis Symfony Extended Range of Vision IOL is manufactured by Abbott Medical Optics, Inc. of Santa Ana, California.

Source: 1, 2

USFDA approves medicine for Dry Eye

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The U.S. Food and Drug Administration approved Xiidra (lifitegrast ophthalmic solution) for the treatment of signs and symptoms of dry eye disease, on Monday, July 11, 2016. Xiidra is the first medication in a new class of drugs, called lymphocyte function-associated antigen 1 (LFA-1) antagonist, approved by the FDA for dry eye disease.

“Normal tear production is needed for clear vision and eye health,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “This approval will provide a new treatment option for patients with dry eye disease.”

Dry eye disease includes a group of conditions in which the eye does not produce an adequate volume of tears or when the tears are not of the correct consistency. The chance of experiencing dry eye increases with age, affecting approximately five percent of the adult population age 30-40 and 10 to 15 percent of adults over age 65, and is more common among women. When severe and left untreated, this condition can lead to pain, ulcers or scars on the part of the eye called the cornea. Dry eye can make it more difficult to perform some activities, such as using a computer or reading for an extended period of time, and it can decrease tolerance for dry environments, such as the air inside an airplane.

The safety and efficacy of Xiidra was assessed in over a thousand patients, in four separate, randomized, controlled studies. These studies included patients 19–97 years of age, of which the majority were female (76 percent). Patients were randomized equally to receive either Xiidra eyedrops or placebo eyedrops, which were used twice a day for twelve weeks. The studies found that groups treated with Xiidra demonstrated more improvement in both the signs and the symptoms of eye dryness than the groups treated with placebo.

The most common side effects of Xiidra include eye irritation, discomfort or blurred vision and an unusual taste sensation (dysgeusia).

Dry eye disease does not routinely occur in children. Safety and efficacy in pediatric patients below the age of 17 years has not been studied.

Xiidra is manufactured by Shire US Inc., of Lexington, Massachusetts.

Source: 1, 2