Regulatory/Legislative News

Alimera Sciences announced that marketing authorization has been granted to Iluvien in Ireland.

GAITHERSBURG, Md. — In an overwhelming panel vote, the U.S. Food and Drug Administration Ophthalmic Devices Panel of the Medical Devices Advisory Committee voted to recommend Alcon’s premarket approval application for the AcrySof IQ ReSTOR +3.0 D multifocal toric IOL.

The Belgian Federal Agency for Medicines and Health Products has granted marketing approval for Iluvien to treat impaired vision associated with chronic diabetic macular edema, according to a press release from Alimera Sciences.

VisionCare Ophthalmic Technologies has announced that the Centers for Medicare and Medicaid Services will reimburse the company’s implantable miniature telescope under a revised Ambulatory Payment Classification designation, according to VisionCare press release.

From international law firm Arnold & Porter LLP comes a timely column that provides views on current regulatory and legislative topics that weigh on the minds of today’s physicians and health care executives.

CHICAGO — The Affordable Care Act has had a modest impact on ophthalmology so far, but a few unknown factors remain, an expert said at the American Academy of Ophthalmology meeting here.

CHICAGO — The free market, not government, should drive the pricing and delivery of health care, Sen. Rand Paul, said at the American Academy of Ophthalmology meeting here.

CHICAGO – Recent federal drug safety legislation may affect patient access to bevacizumab, an expert said at a press briefing here.

CHICAGO — U.S. Food and Drug Administration studies have shown good post-LASIK visual outcomes and low complication rates, a speaker told colleagues here.

The U.S. Food and Drug Administration has approved use of VisionCare Ophthalmic Technologies’ implantable miniature telescope in a younger group of patients than was previously approved, according to a company press release.