Olopatadine ophthalmic solution is used for the symptomatic management of ocular itching associated with allergic conjunctivitis.
Efficacy of olopatadine has been established in several clinical studies, including environmental studies and conjunctival antigen challenge studies. In a 6-week environmental study, twice-daily administration of olopatadine 0.1% ophthalmic solution was shown to be effective in improving manifestations of allergic conjunctivitis. In addition, results of several conjunctival antigen challenge studies indicate that in healthy individuals who were challenged with conjunctival antigen initially and 8 hours after receiving olopatadine 0.1% ophthalmic solution or vehicle, olopatadine was more effective than vehicle in providing relief of ocular itching and redness associated with allergic conjunctivitis. In clinical studies of up to 12 weeks' duration, once-daily administration of olopatadine 0.2% ophthalmic solution was shown to be effective in improving ocular itching associated with allergic conjunctivitis. Ophthalmic olopatadine generally provides symptomatic relief of itching within 30 minutes following initiation of therapy. Once symptomatic improvement has been established, olopatadine therapy should be continued for as long as necessary to sustain improvement.
Avoidance of allergen and other triggering factors (e.g., irritants) and application of cold compresses and lubricating eye drops are the initial means of managing allergic conjunctivitis. Drug therapy generally is reserved for use when such avoidance is not possible or is ineffective and can include both prophylactic (e.g., mast-cell stabilizers) and symptomatic (e.g., topical and/or systemic antihistamines, topical vasoconstrictors, topical steroidal and nonsteroidal anti-inflammatory agents [NSAIAs]) therapy. The specific therapy(ies) employed will depend on the characteristics and severity of the allergic conjunctivitis. For patients with seasonal allergic conjunctivitis, prophylaxis with a mast-cell stabilizer often is initiated before and maintained throughout the pollen season, and symptomatic therapy with other agents (e.g., topical antihistamines, topical NSAIAs) generally is initiated as necessary to provide acute relief. Topical steroids usually are reserved for short-term use in patients with moderate to severe symptoms of allergic conjunctivitis.
Seasonal Allergic Rhinitis
Olopatadine nasal spray is used to provide symptomatic relief of seasonal allergic rhinitis (e.g., hay fever).
Efficacy and safety olopatadine nasal spray in the symptomatic management of seasonal allergic rhinitis have been established in 5 randomized, placebo-controlled studies of 2 weeks' duration in adults and children 6 years of age and older with seasonal allergic rhinitis. In 3 of the studies (which included 1598 adults and children 12 years of age and older), treatment with olopatadine 0.6 or 0.4% nasal spray (2 sprays in each nostril twice daily) was more effective than placebo in reducing nasal symptoms (i.e., nasal congestion, rhinorrhea, nasal itching, sneezing), as assessed by reduction in reflective total nasal symptom scores. In the other 2 studies (which included 588 children 6-11 years of age), treatment with olopatadine 0.6% nasal spray (1 spray in each nostril twice daily) was more effective than placebo in reducing nasal symptoms (i.e., nasal congestion, rhinorrhea, nasal itching, sneezing), as assessed by reduction in reflective total nasal symptom scores. In 3 of the 5 studies, patients receiving olopatadine nasal spray had substantially greater decreases in reflective symptom scores for itchy eyes and watery eyes (secondary end points) compared with those receiving placebo; ocular redness was not evaluated in these studies.
In clinical studies in adults and children 12 years of age and older, onset of action was evident after one day following administration of olopatadine nasal spray. Onset of action also was evaluated in 3 environmental exposure unit studies in which patients with seasonal allergic rhinitis were exposed to high levels of pollen in the environmental exposure unit and then received a single dose (two sprays in each nostril) of olopatadine hydrochloride or vehicle; in these studies, olopatadine 0.6% nasal spray was found to have an onset of action of 30 minutes.