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olopatadine 0.2% ophthalmic solution
Olopatadine blocks H1-receptors on ocular mast cells and other immune cells to reduce histamine-mediated itching and allergic inflammation in the eye.
Olopatadine 0.2% ophthalmic solution, developed by Allergan, is an antihistamine used to treat ocular itching due to allergic conjunctivitis. Despite its efficacy, it lacks an FDA label, which may limit its market potential. The drug has a favorable safety profile but includes common side effects such as headache and eye irritation. It competes in a crowded market of ophthalmic antihistamines, with moderate revenue and growth potential. The drug's mechanism involves blocking histamine receptors, reducing the inflammatory response associated with allergies.
At a glance
| Generic name | olopatadine 0.2% ophthalmic solution |
|---|---|
| Also known as | Pataday™ |
| Sponsor | Allergan |
| Drug class | H1-receptor antagonist |
| Target | H1-receptor |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | FDA-approved |
Mechanism of action
Olopatadine is a selective H1-receptor antagonist that prevents histamine from binding to its receptors on mast cells and other cells involved in allergic responses in the eye. By blocking these receptors, it reduces the release of inflammatory mediators and directly counteracts histamine-induced itching, providing rapid symptomatic relief of ocular allergic symptoms.
Approved indications
- Allergic conjunctivitis (ocular itching associated with allergies)
Common side effects
- Ocular irritation
- Headache
- Conjunctival hyperemia
- Lid edema
Key clinical trials
- Evaluation of the Safety and Efficacy of Ketotifen 4.0% Patch as Compared to Placebo Patch, Olopatadine 0.2% Ophthalmic Solution, and Artificial Tears in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis (PHASE2)
- Efficacy and Toxicity of Bepotastine 1,5% PF vs Olopatadine 0,2% With BAK on Allergic Conjunctivitis Treatment (PHASE4)
- DEXTENZA Therapy for Treatment of Allergic Conjunctivitis (PHASE4)
- Olopatadine Hydrochloride Ophthalmic Solution Study in Chinese Subjects (PHASE3)
- A Comparison of the Safety and Comfort of AC-170 (PHASE1)
- Olopatadine 0.2% for the Treatment of Allergic Conjunctivitis (PHASE3)
- Olopatadine Eye Drops and Allergy Skin Testing (NA)
- Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients (PHASE4)
Patents
| Patent | Expiry | Type |
|---|---|---|
| US7049294B2 |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- olopatadine 0.2% ophthalmic solution CI brief — competitive landscape report
- olopatadine 0.2% ophthalmic solution updates RSS · CI watch RSS
- Allergan portfolio CI