Regulatory/Legislative News

The FDA identified four deficiencies in an amended investigational device exemption application for a second pilot study of product candidate EyeGate Ocular Bandage Gel and is requesting additional information on the manufacturing process, according to a press release from EyeGate Pharmaceuticals.

Imprimis has received a patent for its MKO Melt compounded formulation from the U.S. Patent and Trademark Office, according to a press release.

Prevent Blindness is lauding the 2018 omnibus spending bill passed by Congress and signed by President Donald Trump last week for including increased funding to two CDC vision health programs.

The Trump administration’s selection of longtime AIDS researcher Robert R. Redfield, MD, to be the next CDC director drew mixed reactions from experts and officials, including some who question his conduct on a research project several decades ago.

Point

Allergan’s patent protection deal with the Saint Regis Mohawk Tribe was struck down by the U.S. Patent Trial and Appeal Board, according to a press release from Mylan, the company that was challenging Allergan’s patents.

Icon Bioscience reported the FDA approved its new drug application for Dexycu, a dropless therapeutic designed to treat inflammation associated with cataract surgery.

The Drug Enforcement Administration has issued a DEA Manufacturer Controlled Substance Registration Certificate for Imprimis Pharmaceuticals’ FDA-registered outsourcing facility, the company announced in a press release.

The DRI OCT Triton series from Topcon Medical Systems has received 510(k) clearance from the FDA, according to a company press release.

The FDA issued a warning to Imprimis Pharmaceuticals regarding false or misleading information in promotional materials for its Dropless, LessDrops, Simple Drops and Klarity C-Drops products. The website and Twitter account for Imprimis include information claiming Simple Drops and Klarity C-Drops are made with FDA-approved components or are FDA approved, which is incorrect, while omitting risk information about the Dropless, LessDrops and Simple Drops products, according to a warning letter dated Dec. 21, 2017, and addressed to Imprimis CEO Mark Baum.