Top stories in 2023: FDA approvals, warning letters, recalls
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FDA warnings about potentially contaminated over-the-counter eye drops topped the news on Healio Optometry this year.
In other big regulatory news, the FDA approved an ophthalmic spray for mydriasis and accepted New Drug Applications for a dry eye treatment and low-dose atropine for myopia.
Read below for summaries of these news stories.
FDA issues warning letters to 8 companies for marketing unapproved eye products
The FDA has issued warning letters to eight companies for manufacturing or marketing unapproved ophthalmic drug products, the agency announced in a press release.
In an effort to protect U.S. consumers from potentially harmful eye products, the FDA addressed those that have been illegally marketed to treat conditions such as conjunctivitis, cataracts and glaucoma. Some of the warning letters also cited quality issues related to product sterility. Read more.
FDA urges consumers to discontinue use of 26 OTC eye drops from several major brands
The FDA has warned consumers not to purchase and to immediately stop using 26 over-the-counter eye drop products due to potential risk for eye infections.
According to an FDA press release, certain eye drops marketed under CVS Health, Leader, Rugby, Rite Aid, Target Up&Up and Velocity Pharma were flagged after FDA investigators reported unsanitary conditions in the manufacturing facilities and positive bacterial test results from environmental sampling of critical drug production areas. The FDA has recommended the manufacturer recall all lots and that consumers properly discard these products. Read more.
FDA warns certain MSM eye drops have bacterial, fungal contamination
The FDA has issued a warning to consumers not to purchase and to immediately stop use of Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops because of bacterial and fungal contamination.
In a press release, the agency urged consumers to dispose of these products and immediately seek medical care if signs or symptoms of an eye infection develop, as using contaminated eye drops could result in a vision-threatening infection that could become life-threatening. Read more.
FDA approves ophthalmic spray for mydriasis
The FDA has approved Eyenovia’s Mydcombi ophthalmic spray for inducing mydriasis, the company announced in a press release.
The fixed-combination of tropicamide 1% and phenylephrine 2.5% is administered through the Optejet device during diagnostic procedures and for short-term pupil dilation. Read more.
Amazon removes eye drops from website after FDA warning
After receiving a warning letter from the FDA, the online retailer Amazon removed seven unregulated eye drop products from its website.
In a letter addressed to Andrew Jassy, CEO of Amazon, the FDA wrote, “These products are especially concerning from a public health perspective. Ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.” Read more.
FDA accepts NDA for Aldeyra dry eye disease treatment
The FDA has accepted a new drug application for reproxalap, an investigational new drug candidate for signs and symptoms of dry eye disease, manufacturer Aldeyra Therapeutics announced in a press release.
Reproxalap is a small-molecule modulator of reactive aldehyde species, which are elevated in ocular inflammatory disease, and has been studied in more than 2,000 patients with no clinically significant safety concerns, the company stated. Read more.
FDA accepts NDA for low-dose atropine eye drop to treat pediatric myopia
Vyluma Inc. has announced that the FDA will review its new drug application for NVK002, a preservative-free, low-dose atropine eye drop for myopia in children aged 3 to 17 years.
“FDA acceptance of our NDA is a major milestone for Vyluma and brings us one step closer to advancing NVK002 as a new, first-in-class treatment option for children with myopia,” Navneet Puri, PhD, founder and chairman of Vyluma, said in a company press release. “NVK002 has been thoroughly tested clinically and adheres to the high-quality standards required of a pharmaceutically manufactured product. We look forward to continuing to collaborate with FDA on the review of this important new treatment.” Read more.
FDA grants 510(k) clearance to Altris IMS platform for OCT scans
Altris AI’s IMS platform, which can store and organize OCT scans and supports improved analysis, has received FDA 510(k) clearance, the company announced in a press release.
“OCT is one of the best and the most difficult for interpretation ophthalmic imaging methods, that is why we wanted to make it more effective and accurate,” Maria Znamenska, MD, PhD, chief medical officer at Altris, said in the release. “With the Altris AI platform, eye care specialists are finally equipped with the tool that helps them detect retinal pathologies, pathological signs and biomarkers. It means less human errors, early detection of the pathologies that can lead to blindness and better patient outcomes as a result.” Read more.
Q&A: FDA warning a reminder that consumers should use doctor-recommended eye drops
The recent FDA warning about 26 potentially contaminated eye drop products, including some marketed under CVS Health, Leader, Rugby, Rite Aid, Target Up&Up and Velocity Pharma, may have caused some confusion among consumers.
Since the warning was issued, several companies have initiated voluntary recalls, urging consumers to discontinue use and seek medical care if they exhibit any signs of infection. Read more.