Regulatory/Legislative News

RetroSense Therapeutics has secured $6 million in Series A financing to investigate the use of gene therapy and optogenetics to restore vision loss, according to a press release.

The Argus II Retinal Prosthesis System has been approved by Health Canada to treat patients with severe to profound outer retinal degeneration, according to a press release from Second Sight Medical Products.

MANF, an investigational drug, has received orphan drug designation for the treatment of retinitis pigmentosa from the U.S. Food and Drug Administration, Amarantus BioScience Holdings announced in a press release.

The Rescan 700 intraoperative optical coherence tomography system has received clearance from the U.S. Food and Drug Administration, according to a press release from Carl Zeiss Meditec.

The European Commission has granted Travatan eye drop solution an additional indication to treat pediatric patients with ocular hypertension or pediatric glaucoma, Alcon announced in a Novartis press release.

The U.S. Food and Drug Administration approved Lannett Company’s abbreviated new drug application for dorzolamide hydrochloride and timolol maleate ophthalmic solution 2%/0.5%.

The U.S. Food and Drug Administration has cleared the Eidon true-color confocal scanner, according to a press release from CenterVue.

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

The U.S. Food and Drug Administration has granted priority review for Eylea injection for the treatment of diabetic retinopathy in patients with diabetic macular edema, according to a Regeneron press release.

From late October through November, notable regulatory decisions were made by the U.S. Food and Drug Administration, Centers for Medicare and Medicaid Services and the Irish Health Products Regulatory Authority – from recommendations to approve a multifocal toric IOL to positive reimbursement statuses for implants and injections.