Ophthalmic products manufacturer Alcon Research has been hit with an untitled letter by the US Food and Drug Administration (FDA) regarding its Pataday allergy eye drops, which regulators claim were marketed using overstated and unsubstantiated claims-the company's fourth such warning in seven years.
Pataday (olopatadine hydrochloride ophthalmic solution .2%) is a prescription allergy eye drop indicated for once-daily use to alleviate itching resulting from allergic conjunctivitis. The product's approved labeling also includes a number of warnings and precautions familiar to most regular uses of contact lenses or other ophthalmic products: Take care not to contaminate the tip of the dropper, keep the solution bottle tightly closed when not in use, don't wear contact lenses if the eyes appear red or otherwise irritated, don't use medicated drops to treat irritation caused by wearing contact lenses, and remove lenses before administering the solution.
The problem, FDA said, is that Alcon's Patient Education Brochure omits some of the necessary safety information.
For example, one warning is supposed to instruct patients to wait 10 minutes after administering drops before replacing contact lenses into the eye. Alcon's warning, however, failed to state that if a patient's eyes remain red after those 10 minutes, they should not insert the contacts regardless of the passage of time.
Though that warning was contained later on in the same brochure, because it was separated from the initial warning, FDA considers it to be misleading.
Unsubstantiated Efficacy Claims
In another instance, FDA alleges that Alcon's efficacy claims broaden its approved indication without regulatory approval. "It is important to identify and treat your allergy eye symptoms," the patient brochure states. The problem, FDA said, is that Pataday is only indicated for ocular itching associated with allergic conjunctivitis-not any of the other various symptoms associated with allergies.
" Therefore, claims that imply that Pataday is effective in treating all 'allergy eye symptoms,' improving "overall eye health," preventing "eye damage," and positively impacting eye comfort are misleading," FDA wrote.
In still other instances, regulators zeroed in on Alcon's claims that the product was effective enough to create "zero itch within minutes and up to 16 hours later with just one drop daily." While this may be true for some patients, FDA said this suggests that it will be the case for all patients who use Pataday. FDA was unable to find data substantiating this claim.
"Specifically, the cited reference, a post-hoc analysis discussed in a poster presentation, does not constitute substantial evidence or substantial clinical experience that would support such a claim," FDA wrote. "In addition, the clinical trials submitted for the approval of Pataday demonstrated that only 30 to 60 percent of patients treated with Pataday experienced complete relief of their ocular itching at the pre-specified time points."
The claims also constituted a claim of superiority, FDA wrote, and called on the company to either cease making the claims or to submit data to FDA to support them.
Fourth Violation Since 2006
The untitled letter is one of several FDA has sent to Alcon Research for similar violations in similar products. In November 2012, FDA sent the company a similar letter regarding its Patanase (olopatadine hydrochloride) Nasal Spray, also indicated for the relief of allergies.
That letter, too, claimed the company had made unsubstantiated efficacy claims, including ones that its product is effective "week after week."
In 2007, the company received another FDA Warning Letter regarding the marketing of Ciprodex, again for unsubstantiated superiority claims.
In 2006, another Warning Letter sent to the company regarding Nevanac also cited the company for unsubstantiated claims.
Alcon did not have any statements to the press available at the time of publication. Regulatory Focus has reached out to the company for further comment and will update this space if we hear back.