FDA Approves Two Prescription Allergy Eye Drops for OTC Use

With the US Food and Drug Administration’s (FDA) approval through the prescription (RX)-to-OTC switch program, 2 eye drops indicated for temporary relief of itchy eyes from allergies will now be available for nonprescription use.

Following the approval, olopatadine hydrochloride ophthalmic solution 0.2% (Pataday Once Daily Relief) and olopatadine hydrochloride ophthalmic solution 0.1% (Pataday Twice Daily Relief) will be commercially available in the US as early as March 2, according to a statement from Alcon.

“At Alcon, we are focused on delivering new eye care products and solutions that meet the needs of patients and consumers, including those who suffer from allergies,” said Sergio Duplan, Region President, North America at Alcon, in a statement. “We are proud to launch prescription-strength Pataday as a convenient, more easily accessible, over-the-counter option to relieve the itchy eyes that almost 1-in-5 Americans experience due to ocular allergies.”

Before the approval, both eye drops had been approved for more than a decade—olopatadine hydrochloride ophthalmic solution 0.2% in 2004 and the 0.1% formulation in 1996—for the treatment of for symptoms associated with allergic conjunctivitis. Olopatadine hydrochloride ophthalmic solution 0.2% is indicated for the treatment of ocular itching associated with allergic conjunctivitis, while the olopatadine hydrochloride ophthalmic solution 0.1% is indicated for the treatment of ocular redness and itching due to allergies.

In a statement from the FDA, the agency advised consumers to stop use of either product and consult their health care provider if they experience eye pain, changes in vision, increased redness of the eye, worsening of itching or itching lasting more than 72 hours. Of note, the FDA also approved a topical gel for temporary relief of arthritis pain through the RX-to-OTC switch process along with the 2 eye drops from Alcon.

“Approval of a wider range of nonprescription drugs has the potential to improve public health by increasing the types of drugs consumers can access and use that would otherwise only be available by prescription,” said Karen Mahoney, MD, acting deputy director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research, in the aforementioned statement. “This includes providing the millions of people that suffer with joint pain from arthritis daily over-the-counter access to another non-opioid treatment option.”