Regulatory/Legislative News

LAS VEGAS – “All providers are now on the same side of the table: doctors, hospitals, other ancillary providers. If they do well taking care of patients, they get to share in the wealth,” Charles Posternack, MD, FACP, FRCPC, said here at Vision Expo West.

The U.S. Food and Drug Administration has granted breakthrough therapy designation to Eylea for the treatment of diabetic retinopathy in patients with diabetic macular edema, according to a press release from Regeneron Pharmaceuticals.

The U.S. Food and Drug Administration has cleared the Investigational New Drug application of Herantis Pharma for a phase 2 clinical study of Cis-UCA eye drops for dry eye syndrome.

Jetrea has been approved in South Korea for the treatment of symptomatic vitreomacular adhesion, according to a ThromboGenics press release.

The European Commission has extended marketing authorization for Ozurdex for the treatment of diabetic macular edema in certain patients, according to an Allergan press release.

“Randomized clinical trials are very good for testing drugs, but when we’re talking about individual foods or dietary patterns, the way these studies are conducted are not a gold standard,” Jeffrey Blumberg, PhD FASN, FACN, CNS, said at the Ocular Nutrition Society symposium, held during Vision Expo East this spring.

A bill in California that intended to allow optometrists to use therapeutic lasers and pharmaceutical agents approved by the U.S. Food and Drug Administration as well as immunizations has been ordered to inactive file, according to the California legislature website.

The U.S. Food and Drug Administration announced on its website that the Center for Devices and Radiological Health has granted a 1-year extension of the Sept. 24, 2014, Unique Device Identification System compliance date for various class 3 medical devices.

This wise saying has roots that go back at least to the 15th century. It has been applied in many different contexts but applies today as good advice to optometrists attempting to navigate the waters of health care reform.

The optometric industry’s associations have been busy the past 2 weeks, as evidenced by Healio’s recent headlines.