Regulatory/Legislative News

The FDA has issued a warning to consumers not to purchase or use South Moon, Rebright or FivFivGo eye drops because of possible contamination and risk for eye infection.

The FDA has agreed to a special protocol assessment agreement modification for Ocular Therapeutix’s phase 3 SOL clinical trial of Axpaxli, an axitinib intravitreal implant for treatment of wet age-related macular degeneration.

A survey conducted after the Jan. 4 American Optometric Association’s virtual townhall highlights optometrists’ concerns about anti-patient, anti-doctor and anti-competitive abuses in the vision plan industry.

The FDA has released a revised draft guidance discussing quality considerations for topical ophthalmic drug products, with the addition of new information related to product sterility and prevention of contamination.

A new proposal in Utah could prohibit the purchase of contact lenses from a prescribing eye doctor, according to a press release from the American Optometric Association.

FDA warnings about potentially contaminated over-the-counter eye drops topped the news on Healio Optometry this year.

Kilitch Healthcare India Limited has voluntarily recalled 25 over-the-counter eye drop products after the FDA warned of unsanitary conditions and potential safety concerns, according to a company press release.

After receiving a warning letter from the FDA, the online retailer Amazon removed seven unregulated eye drop products from its website.

SAN FRANCISCO — Improved technologies and advanced techniques have given corneal laser surgery a valuable role in therapeutic treatment, according to a presentation here.

The FDA has issued warning letters to eight companies for manufacturing or marketing unapproved ophthalmic drug products, the agency announced in a press release.