NDAOPHTHALMICSOLUTION/DROPS2 Generics Approved
Approved
May 2006
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
19
Data completeness
3/8 — Basic
QOLIANA (brimonidine tartrate) by Novartis is alpha-2 adrenergic receptor agonist with a peak ocular hypotensive effect occurring at two hours post-dosing. First approved in 2006.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
QOLIANA (brimonidine tartrate) is an alpha-2 adrenergic receptor agonist ophthalmic solution approved for glaucoma and ocular hypertension management. It reduces intraocular pressure through dual mechanism: decreased aqueous humor production and increased uveoscleral outflow, with peak effect at two hours post-dosing.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (60/100), signaling potential team downsizing or transition planning within Novartis ophthalmology.
Mechanism of Action
alpha-2 adrenergic receptor agonist with a peak ocular hypotensive effect occurring at two hours post-dosing. Fluorophotometric studies in animals and humans suggest that brimonidine tartrate has a dual mechanism of action by reducing aqueous humor production and increasing uveoscleral outflow.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (19)
A Study Comparing the Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution 0.025% With Sodium Hyaluronate Relative to Lumify in Adult Subjects With Ocular Redness
Started May 2025
578 enrolled
Ocular Redness
Evaluation of the Safety and Pharmacokinetics of Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Combination Ophthalmic Solution
Started Apr 2023
512 enrolled
Allergic Conjunctivitis
Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination in Adults With Seasonal Allergic Conjunctivitis
Started Nov 2022
229 enrolled
Seasonal Allergic Conjunctivitis
Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination for the Treatment of Allergic Conjunctivitis
Started Oct 2022
188 enrolled
Allergic Conjunctivitis
"Efficacy and Safety of Brimonidine Tartrate Preservative-Free Formulation in Adults With Ocular Redness"
Started May 2022
380 enrolled
Ocular Redness
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.