FDA approves Bausch + Lomb Alaway antihistamine eyedrops

September 25, 2020

Pollen, ragweed, grass, animal hair, and dander allergies targeted by new eyedrops

The U.S. Food and Drug Administration (FDA) approved Alaway Preservative Free (ketotifen fumarate 0.035%) antihistamine eye drops by Bausch + Lomb as the first over-the-counter (OTC) preservative-free formulation eye drop. The drug has been approved as a temporary relief for allergy sufferers with itchy eyes.

The company anticipates the drug will be available for purchase at major retailers in time for the peak allergy season of spring 2021.

Alaway Preservative Free is indicated for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair, and dander in adults and children 3 years of age and older. It is formulated to relieve eye itch within minutes and can provide up to 12 hours of eye itch relief with one dose, according to the company.

ODs weigh in

Optometry Times® asked ODs to weigh in on the new drops and found mixed reactions with overall excitement for its uses with sensitivities.

Jade Coats, OD, in Rogers, AR, says she is happy to offer her patients a preservative-free option for allergy season.

“As someone who personally uses a daily antihistamine eye drop, a preservative-free formulation may be a game changer in the treatment of itchy eyes due to allergies,” she says.

Editorial Advisory Board member Tracy Schroeder Swartz, OD, FAAO, in Madison, AL, says a preservative-free option for patients suffering from allergic conjunctivitis is good news.

“Although in my experience olopatadine (Pataday, Alcon) is better for severe allergy sufferers and also now available over the counter. But for those with sensitivities, Alaway PF may be more efficacious,” she says.

This new option is a welcome and long overdue option for patients experiencing eye allergies, says Editorial Advisory Board member Chris Wroten, OD, in Hammond, LA.

“Ketotifen fumarate is an antihistamine/mast cell stabilizer with a proven track record of success against allergic conjunctivitis, both originally as a prescription-only medication and in recent years as an over-the-counter product,” he says. “We’ve known for decades that eye drop preservatives can themselves be a source of ocular allergy, so Alaway Preservative Free makes perfect sense.”

Vin Dang, OD, FAAO, in Bakersfield, CA, says that doctors treating the ocular surface welcome this preservative-free version of Bausch + Lomb’s Alaway OTC drops.

“Any time we can reduce the potential offenders like preservatives on the ocular surface, we have happy patients and that makes for happy doctors,” he says.

Bausch + Lomb acquired the U.S. rights to Alaway Preservative Free from Eton Pharmaceuticals in 2019.

Related: 1-800 Contacts in talks for buyout