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Ketorolac Tromethamine 0.45%
Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis and thereby decrease inflammation and pain.
Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis and thereby decrease inflammation and pain. Used for Postoperative ocular inflammation and pain, Ocular pain and inflammation following eye surgery.
At a glance
| Generic name | Ketorolac Tromethamine 0.45% |
|---|---|
| Also known as | Acuvail |
| Sponsor | Bucci Laser Vision Institute |
| Drug class | Nonsteroidal anti-inflammatory drug (NSAID) |
| Target | Cyclooxygenase (COX-1 and COX-2) |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | FDA-approved |
Mechanism of action
As an NSAID, ketorolac blocks COX-1 and COX-2 enzymes, which are responsible for producing prostaglandins that mediate inflammation, pain, and fever. The ophthalmic formulation (0.45%) is applied topically to the eye to reduce ocular inflammation and pain following surgical procedures or injury. Its potent anti-inflammatory effect makes it particularly useful in ophthalmology for managing postoperative discomfort.
Approved indications
- Postoperative ocular inflammation and pain
- Ocular pain and inflammation following eye surgery
Common side effects
- Ocular irritation or stinging
- Conjunctival erythema
- Corneal effects (rare)
Key clinical trials
- Effect of Preoperative Topical Ketorolac on Aqueous Cytokine Levels and Macular Thickness in Cataract Surgery Patients (PHASE4)
- Artificial Tears Versus Preservative Free Ketorolac Trometamol 0.45% for Acute Viral Conjunctivitis (PHASE2, PHASE3)
- A 6 Month Study to Evaluate the Safety, Analgesic Efficacy of ACUVAIL™ (Ketorolac Tromethamine Ophthalmic Solution) 0.45%, in Post-PRK Corneal Wound Healing
- A Comparison of Peak Aqueous Penetration of Acuvail (Ketorolac 0.45%), Xibrom (Bromfenac 0.09%), and Nevanac (Nepafenac 0.1%)in Patients Undergoing Phacoemulsification (PHASE4)
- A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)in Patients Undergoing Phacoemulsification (PHASE4)
- A Comparison of Post Phacoemulsification Aqueous Flare in Patients Using Ketorolac 0.45% 2 Times Daily (BID) and Bromfenac 0.09% 2 Times Daily (BID) (PHASE4)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ketorolac Tromethamine 0.45% CI brief — competitive landscape report
- Ketorolac Tromethamine 0.45% updates RSS · CI watch RSS
- Bucci Laser Vision Institute portfolio CI