Regulatory/Legislative News

WAILEA, Hawaii ― At Hawaiian Eye 2018, Mark Baum, CEO of Imprimis Pharmaceuticals, discusses regulatory challenges facing compounding pharmacies and ways his company and others would like to work with physicians to bring changes to those hurdles.

The FDA has cleared the Omni Surgical System, according to a press release from Sight Sciences.

Pixium Vision has received approval from the FDA to begin a clinical feasibility study for Prima, a miniaturized wireless photovoltaic subretinal implant, for the treatment of atrophic dry age-related macular degeneration.

The FDA has waived the $2.4 million new drug application filing fee for pSivida’s Durasert 3-year microinsert for posterior segment uveitis, according to a company press release.

The FDA has granted tentative approval to Perrigo Company plc for its generic version of Prolensa, according to a company press release.

Shire plc and Shire Pharma Canada ULC announced the approval of Xiidra (lifitegrast ophthalmic solution 5%) for the treatment of dry eye disease in adults by Health Canada.

Glaukos Corporation has submitted an investigational device exemption application to the FDA to study the iStent infinite trabecular micro-bypass system, a three-stent device designed to reduce IOP in cases of refractory glaucoma in a standalone procedure, according to a company press release.

The FDA has accepted Sun Pharmaceutical Industries’ new drug application for OTX-101, an aqueous solution intended for treatment of dry eye disease, the company announced in a press release.

Glaukos has submitted a premarket approval application to the FDA for its iStent inject trabecular micro-bypass stent, according to a company press release.

The most-read stories on Healio.com/OSN in December included an FDA approval and news from recent journal articles.