Regulatory/Legislative News

The FDA has granted orphan drug designation to a drug candidate for the treatment of Stargardt disease, Acucela announced in a press release.

President Barack Obama, JD, said it would be “reckless” for Republicans to repeal the Affordable Care Act without having a suitable replacement ready to go.

Genentech announced the FDA approved Lucentis for the treatment of myopic choroidal neovascularization, the fifth FDA-approved indication for the drug.

From international law firm Arnold & Porter Kaye Scholer 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.

Ophthalmology news in 2016 ran the gamut from important drug trials and approvals to studies regarding the cause and treatments of a multitude of ailments.

Last week the FDA announced approval of the AcrySof IQ ReSTOR +3.0 D multifocal toric IOL in the U.S. with available toric powers ranging from about 0.6 D to about 2.0 D in the corneal plane (SND1T2-SND1T5 lenses, respectively). This approval is a major breakthrough for patients. As I have blogged before, patients with more than about 1D of corneal astigmatism were previously not well suited to multifocal implants which were available only in spherical powers. We have performed several studies in patient satisfaction using the MDbackline follow-up care system and shown that achieving “top box” satisfaction absolutely requires astigmatism to 0.5 D or less. That’s difficult to reach with a limbal relaxing incision in patients with higher cylinder but very achievable with a toric lens.

I wish I could provide an intelligent response to this question. My office manager has been busily educating herself regarding the requirements and (hopefully) getting prepared to implement the required procedural infrastructure. That being said, my level of involvement in the process remains at this superficial level, at least for now. Hopefully, my confidence in my administrative staff to “get it right” will be well founded, or we will be in for a bit of a rude awakening.

In October, the CMS released the final rule to implement the Medicare Access and CHIP Reauthorization Act of 2015, effectively ending the SGR formula and introducing a new payment adjustment path for ophthalmologists who serve Medicare patients.

The Merit-based Incentive Payment System, or MIPS, was scheduled to take effect Jan. 1. It will not be repealed by the incoming Republican Congress as it helped design it and voted for it.

Health Canada has approved the Trab360 trabeculotomy system, according to a Sight Sciences press release.