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ketorolac tromethamine 0.4%
ketorolac tromethamine 0.4% is a Nonsteroidal anti-inflammatory drug (NSAID) Small molecule drug developed by Clinica Oftamologica Zona Sul. It is currently FDA-approved for Postoperative ocular inflammation and pain following cataract surgery, Ocular itching associated with seasonal allergic conjunctivitis, Corneal refractive surgery pain and inflammation.
Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation and pain.
Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation and pain. Used for Postoperative ocular inflammation and pain following cataract surgery, Ocular itching associated with seasonal allergic conjunctivitis, Corneal refractive surgery pain and inflammation.
At a glance
| Generic name | ketorolac tromethamine 0.4% |
|---|---|
| Sponsor | Clinica Oftamologica Zona Sul |
| 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. In ophthalmic formulation (0.4% solution), it reduces ocular inflammation and pain by local inhibition of these pathways. The tromethamine salt form enhances solubility and bioavailability for topical ocular delivery.
Approved indications
- Postoperative ocular inflammation and pain following cataract surgery
- Ocular itching associated with seasonal allergic conjunctivitis
- Corneal refractive surgery pain and inflammation
Common side effects
- Ocular irritation or stinging
- Conjunctival hyperemia
- Headache
- Corneal erosion or ulceration (rare)
Key clinical trials
- Comparing Intramuscular Fentanyl and Ketorolac With Nerve of Arnold (NOA) Block for Bilateral Myringotomy (PHASE4)
- Study of Complication Rates in Cataract Surgery Patients Treated With Combined Pre-operative NSAID, OMIDRIA, and Subconjunctival Triamcinolone Acetonide Compared With Peri-operative SOC (PHASE1, PHASE2)
- Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity (PHASE4)
- Comparing Acular LS and Pred Forte in Reducing Post-selective Laser Trabeculoplasty Anterior Chamber Flare and Cells (NA)
- Trial Comparing Ketorolac Tromethamine 0.4% & Prednisolone Acetate 1% in Reducing Post-SLT Anterior Chamber Flare & Cells
- Comparison of Topical Ketorolac 0,4% Versus Placebo in Cataract Surgery (PHASE4)
- Anti-inflammatory Efficacy for Prophylaxis of Cystoid Macular Edema (CME) After Phacoemulsification (PHASE4)
- Nevanac 3-Month Safety Study With QID Dosing (PHASE3)
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 0.4% CI brief — competitive landscape report
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- Clinica Oftamologica Zona Sul portfolio CI
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Related
- Drug class: All Nonsteroidal anti-inflammatory drug (NSAID) drugs
- Target: All drugs targeting Cyclooxygenase (COX-1 and COX-2)
- Manufacturer: Clinica Oftamologica Zona Sul — full pipeline
- Therapeutic area: All drugs in Ophthalmology
- Indication: Drugs for Postoperative ocular inflammation and pain following cataract surgery
- Indication: Drugs for Ocular itching associated with seasonal allergic conjunctivitis
- Indication: Drugs for Corneal refractive surgery pain and inflammation
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