Top FDA stories of 2024: New technology, potentially contaminated eye drops
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Every year Healio covers a wide range of optometry-related news from the FDA, and 2024 was no exception.
Our top FDA stories included breakthrough designation for SightGlass Vision’s diffusion optics technology spectacle lenses and warnings about potentially contaminated eye drops.
Here are optometry’s most popular FDA stories of 2024.
SightGlass receives FDA breakthrough designation for spectacle lenses that slow myopia
The FDA has granted breakthrough device designation to SightGlass Vision’s diffusion optics technology spectacle lenses, which are designed to slow myopia progression in children.
“Recent studies illustrate that about half of U.S. children are myopic, yet most are not receiving treatments proven to slow myopia progression,” Andrew Sedgwick, SightGlass Vision’s CEO, said in a company press release. “We are enthusiastic about more closely collaborating with the FDA as we pursue U.S. market clearance.” Read more.
FDA warns against use of possibly contaminated copycat eye drops
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.
According to an agency press release, these unapproved eye drops can easily be confused with Bausch + Lomb’s Lumify eye drops (brimonidine tartrate 0.025%), an over-the-counter product approved for redness relief. The South Moon, Rebright and FivFivGo labeling claims that the products are “helpful in relieving the symptoms of eye redness, dry eyes, glaucoma, presbyopia, cataracts and ocular hypertension.” Read more.
FDA clears fully autonomous AI for portable diabetic retinopathy screening
AEYE Health has received the first-ever FDA clearance for a fully autonomous AI that can diagnose referable diabetic retinopathy using retinal images taken by a handheld camera, according to a company-issued press release.
This affordable and accessible solution is especially suited for point-of-care screening at clinics or at home, the company stated, and can help address the leading cause of blindness in working-age adults. Read more.
FDA agrees to LYNX-2 trial of phentolamine ophthalmic solution for poor night vision
Ocuphire Pharma has received agreement from the FDA under a special protocol assessment for its LYNX-2 phase 3 trial, a study of phentolamine ophthalmic solution for treatment of reduced visual acuity under low light conditions.
According to a company press release, the FDA agreed that the clinical trial protocol and planned statistical analysis could adequately address objectives supporting regulatory submission and future marketing application. Read more.
Regener-Eyes addresses violations cited in FDA warning letter
After receiving a warning letter from the FDA on Aug. 16 citing “significant violations” related to two Regener-Eyes ophthalmic products, the company has implemented several improvements to address the concerns.
According to the FDA, Regener-Eyes and its manufacturer, Regenerative Processing Plant, have distributed multi-dose Regener-Eyes Professional Ophthalmic Solution and Regener-Eyes Lite Ophthalmic Solution directly to optometrists, eye clinics and consumers in the U.S. as sterile, preservative-free products intended for dry eye relief. Because of this claim, the FDA described both products as “unapproved new drugs” being marketed in violation of interstate commerce law. Read more.