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New formulation makes once-a-day allergy treatment possible
Olopatadine 0.2% effectively treated ocular itching at the onset of allergic symptoms and at 16 hours, signaling a jump from twice-daily drops.
Ocular allergy drops containing 0.2% olopatadine effectively control itching associated with allergic conjunctivitis with a once-a-day dosage, according to a study.
Using a conjunctival allergen challenge (CAC) model, Francis S. Mah, MD, of the University of Pittsburgh School of Medicine, and colleagues evaluated the new therapy to determine its efficacy over an extended period of time.
The leading treatment for allergic conjunctivitis is Patanol (olopatadine 0.1%, Alcon), but the 0.2% formula, called Pataday, was developed for an enhanced effect, the researchers said.
“A novel formulation, olopatadine 0.2% has been developed to improve efficacy by increasing the duration of action,” the researchers wrote.
Conjunctival allergen challenge
The double-masked, randomized, placebo-controlled study included 36 patients with a history of allergic conjunctivitis.
At the first visit, the patients were screened for positive reactions to allergic antigens, including itching and redness scores of 2 or more.
On day 7, the researchers performed a second CAC to confirm the development of ocular allergies.
Subjects were randomly assigned on day 14 to receive either one drop of olopatadine 0.2% in both eyes, one drop of olopatadine 0.2% in one eye and placebo in the other or one drop of placebo in both eyes, according to the study. The eyes were then exposed to allergic antigens.
On day 28, the patients were divided into the same three groups to receive the same drug regimen, but with exposure to antigens 16 hours later.
The primary efficacy variable was ocular itching and was based on 10-minute assessments post-CAC. Secondary variables were conjunctival, episcleral or ciliary redness, according to the study.
Extended efficacy
In both the onset-of-action and 16-hour duration-of-action challenges, olopatadine 0.2% was statistically significantly better (P < .05) than the placebo in the treatment of ocular itching.
Ocular itching scores in the onset CAC were reduced by 1.29 score units compared with placebo at the 10-minute assessment time, a 67% decrease. In the 16-hour CAC, the ocular itching scores decreased by 0.57 score units, a 44% decrease.
The results for the treatment of all types of ocular redness were also statistically better (P < .05) than placebo, according to the study.
The results showed no serious adverse events, and none of the subjects experienced a clinically significant change in visual acuity, ocular sign or fundus parameters.
“The results demonstrate the rapid and long-lasting efficacy of olopatadine 0.2% in treatment of allergic conjunctivitis, supporting once-daily dosing,” the study authors wrote.
New formula
Dr. Mah told Ocular Surgery News that Alcon added povidone to the formula of olopatadine 0.2%.
“The reason that povidone is in the formulation is that it helps to solubilize the olopatadine at a higher concentration,” he said during a telephone interview. “[Alcon] seems to have really tried to optimize the formulation, not only for long-lasting effect but also for comfort.”
According to Dr. Mah, the two primary attributes that allergy-sufferers look for in a medication are the speed of treatment onset and the duration of activity.
“Twice a day is great, but once a day is probably better, and if you had something that lasted longer than 8 hours, maybe if it lasted 24 hours or even 36 hours or longer, that would be an improvement,” he said.
For more information:
- Francis S. Mah, MD, can be reached at University of Pittsburgh Medical Center, Eye and Ear Institute, 203 Lothrop St., Eighth Floor, Pittsburgh, PA 15213, U.S.A.; +1-412-647-2200; fax: +1-412-647-5119. Dr. Mah is a paid consultant for Alcon.
- Alcon, the maker of Pataday, can be reached at 6201 S. Freeway, Fort Worth, TX 76134, U.S.A.; +1-817-293-0450; fax: +1-817-568-6142; Web site: www.alconlabs.com.
- Jared Schultz is an OSN Staff Writer who covers all aspects of ophthalmology. He focuses geographically on Europe and the Asia-Pacific region.