Regulatory/Legislative News

The FDA has issued a close-out letter to STAAR Surgical, lifting a 2014 warning regarding the manufacture of Visian Implantable Collamer Lens devices, the company announced in a press release.

Johnson & Johnson Vision’s iDESIGN Refractive Studio LASIK platform has been approved by the FDA, according to a press release.

Optovue has received 510(k) clearances from the FDA for its AngioAnalytics OCT angiography blood vessel measurement technology and for its 3-D projection artifact removal software, as well as expanded clearance for noncontact, quantitative measurements of the epithelial and stromal layers of the cornea, or epithelial thickness mapping, according to press releases.

The FDA has granted regenerative medicine advanced therapy designation to choroideremia treatment NSR-REP1, Nightstar Therapeutics announced in a press release.

Issues observed at Sun Pharma’s Halol facility in Gujarat, India, detailed in an FDA warning letter in December 2015, have been addressed, and the inspection is now closed, according to the company.

Iluvien will receive a partial review of reimbursement guidance from the United Kingdom National Institute for Health and Care Excellence, Alimera Sciences announced in a press release.

The FDA has granted orphan drug designation to GPLSCD01, an investigational product for the treatment of limbal stem cell deficiency, Chiesi USA and Holostem Terapie Avanzate announced in a press release.

CMS has issued a preliminary decision to establish a product specific Healthcare Common Procedure Coding System J code for Photrexa drug formulations, according to a press release from Avedro.

Eyenovia has received Notices of Allowance from the U.S. Patent and Trademark Office for two patent applications providing coverage on physiologic microdroplet ejection diameters and velocities, according to a press release.

EyeGate Pharmaceuticals has addressed three of the four outstanding action items regarding an FDA investigational device exemption amendment filed for its ocular bandage gel, the company announced in a press release.