ACULAR LS (ketorolac tromethamine)
ACULAR LS is an ophthalmic solution used to manage discomfort in patients who have recently undergone corneal refractive surgery. It specifically helps with the ocular pain and burning or stinging sensations that often follow these types of eye procedures. As a nonsteroidal anti-inflammatory drug, it is prescribed to improve patient comfort during the post-surgical recovery phase.
How ACULAR LS Works
This medication works by inhibiting the body's ability to produce prostaglandins. By blocking the biosynthesis of these compounds, the drug exerts anti-inflammatory and analgesic effects. This process helps reduce the physical sensations of pain and burning at the site of the surgery.
Details
- Status
- Prescription
- First Approved
- 2003-05-30
- Patent Cliff
- 2027
- Routes
- OPHTHALMIC
- Dosage Forms
- SOLUTION/DROPS
ACULAR LS Approval History
What ACULAR LS Treats
1 indicationsACULAR LS is approved for 1 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Ocular Pain
ACULAR LS Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to ACULAR LS
3 of 4FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
35 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05324358 | NTM-001-CT001 | Ph 3 | suspended | Ketorolac Applied by Continuous IV Infusion for Treatment of Moderately Severe Postoperative Pain Following Bunionectomy |
| NCT06513208 | HP-00109853 | Ph 4 | recruiting | Ketorolac Effects on Post-operative Pain and Lumbar Fusion |
| NCT05641363 KETODOSE | KETODOSE20221107 | Ph 3 | completed | Comparison of Ketorolac at Three Doses in Children With Acute Pain |
| NCT03913702 results posted | UTMB IRB #: 18-0156 | Ph 2 | terminated | Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement |
| NCT03453541 | 4923 | Ph 4 | terminated | Ketorolac Use in Pediatric Patients Undergoing Tonsillectomy |
| NCT04733326 | CairoU0 | Ph 1 | completed | Evaluation of Post-operative Pain and Expression of IL-8 Using Ketolac or Cryoirrigation as a Final Flush in Single Visit Endodontic Treatment in Teeth With Symptomatic Irreversible Pulpitis and Apical Periodontitis.Randomized Clinical Trial. |
| NCT06395428 | WMed-2024-1032 | Ph 4 | recruiting | Haloperidol for Pain Control in Patients With Acute Musculoskeletal Back Pain in the Emergency Department |
| NCT06160778 KETOAPP | 23-0952 | Ph 3 | recruiting | Intravenous Ketorolac Vs. Morphine In Children With Acute Abdominal Pain |
| NCT04666701 | EMS1319 - ESCÓCIA | Ph 2 | withdrawn | Efficacy and Safety of Escócia Association in the Treatment of Acute Pain |
| NCT05382546 | NTM-001-AHC001 | Ph 1 | completed | A Pharmacokinetic Study of Intravenous NTM-001 in Healthy Chinese Subjects |
| NCT04439396 | 19-387 | Ph 1 | completed | Toradol (Ketorolac) in Breast Surgery to Reduce Pain & Opioid Use |
| NCT04554862 | M419 | Ph 4 | completed | The Analgesic Efficacy of Magnesium and Ketorolac in Ultrasound Supraclavicular Block |
| NCT04939987 | IRB00074034 | Ph 2, Ph 3 | withdrawn | Opioid-Free Pain Control Regiment Following Robotic Radical Prostatectomy |
| NCT01471899 | CTRGEMS0611 | Ph 3 | completed | Comparison Of Ketorolac Tromethamine Oral Drops Versus Naproxen For Moderate to Severe Back Pain Treatment |
| NCT01471886 | CTREMS0611 | Ph 3 | completed | Comparison Of Ketorolac Tromethamine Versus Naproxen For Moderate to Severe Back Pain Treatment |
| NCT02902770 results posted | 2016-03-09 | Ph 4 | completed | Intravenous Lidocaine and Ketorolac for Pain Management |
| NCT02923687 | AZadUMS-P/190/D | Ph 2 | completed | Premedication Efficacy of Ketorolac Infiltration on Post Endodontic Pain |
| NCT03410212 IANB | IR.IAU.DENTAL.REC.1396,31 | Ph 2 | completed | Efficacy of Block Injection of an Anti Inflammatory Medicine in Patients With Mandibular Dental Pain |
| NCT02658149 results posted | 2015-422 | Ph 4 | completed | Psoas Compartment Block Versus Periarticular Local Anesthetic for Total Hip Arthroplasty |
| NCT02313675 results posted | PRO14110464 | Ph 4 | completed | Pain Outcomes of Intra-operative IV Tylenol and/or IV Toradol for Carpal Tunnel and Distal Radius Fracture Surgeries |
| NCT03007381 KANGAROO | KANGAROO | Ph 4 | withdrawn | Ketorolac for Analgesia followiNG Autologous Breast RecOnstructiOn |
| NCT02638831 | DRL_RUS/PMS/2012/KETG | Ph 4 | completed | Ketorol Gel in Gonarthrosis and Low Back Pain |
| NCT02729285 | 2014MEKY042 | Ph 4 | completed | Preoperative Ketorolac for Pain Control in Scleral Buckle Surgery |
| NCT02601911 | AzadUMS P/66/D | Ph 2 | completed | Effect of Premedication on Success of Inferior Alveolar Nerve Block Injection |
| NCT02614118 | AZadUMS-P/139/D | Ph 2 | completed | Premedication Efficacy of Oral Ketorolac and Ketorolac/ Acetaminophen on Post Treatment Pain |
| NCT02536430 | AZadUMS-P/212/D | Ph 2 | completed | Efficacy of Ketorolac Buccal Infiltration on Success Rate of Inferior Alveolar Nerve Block |
| NCT00907114 | HJM 1667/09.03.24 | Ph 2 | completed | Topic Ketorolac Added to Panphotocoagulation in Proliferative Diabetic Retinopathy |
| NCT01596166 EDMigraine-4 | EDMIGR-004-01 | Ph 4 | completed | Intravenous Ketorolac and Metoclopramide for Pediatric Migraine in the Emergency Department |
| NCT01542190 | 0018014600011 | Ph 4 | completed | Comparison of Topical Ketorolac 0,4% Versus Placebo in Cataract Surgery |
| NCT02000401 | 0703-2012-SPRIX | Ph 4 | completed | Intranasal Ketorolac Tromethamine (Sprix) for Acute Pain of Interstitial Cystitis Flare of Pain |
| NCT01365624 results posted | ROX 2007-02 | Ph 1 | completed | Safety and Pharmacokinetics Study of Intranasal Ketorolac in Elderly and Nonelderly Adult Healthy Subjects |
| NCT01436032 | N1539-05 | Ph 3 | terminated | Efficacy, Safety and Tolerability Study of N1539 in Subjects After Abdominal Laparoscopic Surgery |
| NCT01291472 | 3214 2011-000367-27 | Ph 4 | completed | Disposition of Intravenous Ketorolac |
| NCT01015235 | KAI-1678-002 | Ph 2 | completed | Safety and Efficacy Study of KAI-1678 to Treat Subjects With Postoperative Pain |
| NCT01021761 results posted | 2009 0199 | Ph 4 | completed | A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)in Patients Undergoing Phacoemulsification |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ACULAR LS FDA Label Details
Indications & Usage
FDA Label (PDF)ACULAR LS is indicated for the treatment of Ocular Pain.
ACULAR LS Patents & Exclusivity
Patents (2 active)
Pro Intelligence Preview
Deep insights for ACULAR LS
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2027
- • 2 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 4 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.