CLINICAL TRIALS PROFILE FOR ACUVAIL

All Clinical Trials for Acuvail

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01001806 ↗	A Comparison of Peak Aqueous Penetration of Acuvail (Ketorolac 0.45%), Xibrom (Bromfenac 0.09%), and Nevanac (Nepafenac 0.1%)in Patients Undergoing Phacoemulsification	Completed	Allergan	Phase 4	2009-10-01	Approximately 126 subjects scheduled to undergo cataract surgery by phacoemulsification, will be randomized in an even allocation (1:1:1) to either Acuvail, Xibrom, or Nevanac. Subjects will be instructed to begin dosing the study medication in the operative eye the day before surgery and continue dosing on the day of surgery. Beginning one hour before surgery, 1 drop of study medication will be instilled by operating room staff approximately every 15 minutes for a total of 3 doses. At the designated time a paracentesis will be performed at the start of the cataract procedure and at least 0.15 cc of aqueous humor will be collected. The sample will be immediately stored on dry ice and shipped to a laboratory for analysis.
NCT01001806 ↗	A Comparison of Peak Aqueous Penetration of Acuvail (Ketorolac 0.45%), Xibrom (Bromfenac 0.09%), and Nevanac (Nepafenac 0.1%)in Patients Undergoing Phacoemulsification	Completed	Frank A. Bucci, Jr., M.D.	Phase 4	2009-10-01	Approximately 126 subjects scheduled to undergo cataract surgery by phacoemulsification, will be randomized in an even allocation (1:1:1) to either Acuvail, Xibrom, or Nevanac. Subjects will be instructed to begin dosing the study medication in the operative eye the day before surgery and continue dosing on the day of surgery. Beginning one hour before surgery, 1 drop of study medication will be instilled by operating room staff approximately every 15 minutes for a total of 3 doses. At the designated time a paracentesis will be performed at the start of the cataract procedure and at least 0.15 cc of aqueous humor will be collected. The sample will be immediately stored on dry ice and shipped to a laboratory for analysis.
NCT01021761 ↗	A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)in Patients Undergoing Phacoemulsification	Completed	Allergan	Phase 4	2009-10-01	Approximately 126 subjects scheduled to undergo cataract surgery by phacoemulsification, will be randomized in an even allocation (1:1:1) to either Acuvail, Xibrom or Nevanac. Subjects will be instructed to begin dosing the study medication in the operative eye the day before surgery and continue dosing on the day of surgery. Beginning one hour before surgery 1 drop of study medication will be instilled by operating room staff approximately every 15 minutes for a total of 3 doses. At the designated time a paracentesis will be performed at the start of the cataract procedure and at least 0.15cc of aqueous humor will be collected. The sample will be immediately stored on dry ice and shipped to a laboratory for analysis.
NCT01021761 ↗	A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)in Patients Undergoing Phacoemulsification	Completed	Frank A. Bucci, Jr., M.D.	Phase 4	2009-10-01	Approximately 126 subjects scheduled to undergo cataract surgery by phacoemulsification, will be randomized in an even allocation (1:1:1) to either Acuvail, Xibrom or Nevanac. Subjects will be instructed to begin dosing the study medication in the operative eye the day before surgery and continue dosing on the day of surgery. Beginning one hour before surgery 1 drop of study medication will be instilled by operating room staff approximately every 15 minutes for a total of 3 doses. At the designated time a paracentesis will be performed at the start of the cataract procedure and at least 0.15cc of aqueous humor will be collected. The sample will be immediately stored on dry ice and shipped to a laboratory for analysis.
NCT01609881 ↗	The Role of Prostaglandins in the Progression of Diabetic Retinopathy	Withdrawn	Vanderbilt University	Phase 1	2012-03-01	Objective of the research study: 1. To measure anterior chamber and vitreous ketorolac (Acuvail®) concentrations after topical administration in patients undergoing routine vitrectomy to determine the ability of the medication to penetrate into the anterior chamber and vitreous cavity, and to compare these levels to the IC50 for the cyclooxygenase-1 and -2 enzymes (COX-1 and COX-2) 2. To measure vitreous concentrations of prostaglandin subtypes (PGE, PGD, PGF) and other inflammatory mediators (Interleukin-1β [IL-1β], IL-6, IL-8, tumor necrosis factor [TNF]-α, VEGF) in both diabetic and nondiabetic patients undergoing vitrectomy 3. To determine if topical ketorolac (Acuvail®) can penetrate the anterior chamber and vitreous cavity sufficiently to decrease levels of intraocular inflammatory mediators that have been shown to be elevated in diabetic patients 4. To serve as a precursor to a 5-year longitudinal clinical trial to determine if chronically administered topical ketorolac (Acuvail®) can prevent, delay or slow diabetic retinopathy. Research hypothesis 1. Ketorolac (Acuvail®) will penetrate the anterior chamber and vitreous cavity sufficiently to achieve levels above the IC50 for COX-1 and COX-2 2. Prostaglandin and other inflammatory mediator levels in the anterior chamber and vitreous cavity will be significantly higher among diabetic patients than nondiabetic controls 3. Acuvail® can significantly lower anterior chamber and vitreous cavity levels of prostaglandins and other inflammatory mediators in diabetic patients
NCT01640171 ↗	Anesthesia Preference for Intravitreal Injection: Topical or Subconjunctival	Completed	Retina Vitreous Associates of Florida	N/A	2012-07-01	Since 2004, intravitreal injection of Avastin, Lucentis, and Macugen for wet age-related macular degeneration, retinal vein occlusion, and diabetic macular edema are being administered in the United States at increasing rates. A 2010 study showed that in Canada and the incidence of injections grew 8 fold from 2005 to 2007 to 25.9 injections per 100,000 citizens. (Campbell 2010) In 2009, in the United States, over 1 million intravitreal injections were administered to Medicare beneficiaries. (Wykoff 2011) In the year 2011, the four doctors in my retina group administered a total of 6,494 intravitreal injections; in 2010, we administered 5021 intravitreal injections. Even though intravitreal injections are commonly administered, the optimal method of anesthetizing the eye prior to injection has yet to be determined. Some physicians use an anesthetic drop, some a soaked cotton pledget, some use an anesthetic gel and some use subconjunctival injected anesthetic. In 2009, the last time the Procedures and Trends Survey (PAT) (Mittra 2009) conducted by the American Society of Retina Specialists (the largest retina society in the world) asked about anesthetic methods for administering intravitreal injections, the following response was given by the 433 respondents: - Topical anesthetic drop: 21.48% - Topical viscous anesthetic: 23.33% - Topical anesthetic & soaked cotton-tip or pledget: 29.79% - Subconjunctival injection of anesthetic: 24.02% - Other: 1.39% An editorial in 2011 in the journal Retina, discusses the lack of good studies assessing optimal anesthetic prior to intravitreal injections. (Prenner 2011).

Clinical Trial Conditions for Acuvail

Condition Name

Condition Name for Acuvail
Intervention	Trials
Cataracts	2
Total Knee Arthroplasty	1
Diabetic Macular Edema	1
Diabetic Retinopathy	1

Condition MeSH

Condition MeSH for Acuvail
Intervention	Trials
Cataract	3
Diabetic Retinopathy	2
Macular Edema	2
Carcinoma	1

Clinical Trial Locations for Acuvail

Trials by Country

Trials by Country for Acuvail
Location	Trials
United States	8
Malaysia	1

Trials by US State

Trials by US State for Acuvail
Location	Trials
Tennessee	2
Georgia	1
Massachusetts	1
New York	1
Minnesota	1

Clinical Trial Progress for Acuvail

Clinical Trial Phase

Clinical Trial Phase for Acuvail
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Acuvail
Clinical Trial Phase	Trials
Completed	6
Withdrawn	2
Recruiting	2

Clinical Trial Sponsors for Acuvail

Sponsor Name

Sponsor Name for Acuvail
Sponsor	Trials
Allergan	3
Frank A. Bucci, Jr., M.D.	2
State University of New York - Downstate Medical Center	1

Sponsor Type

Sponsor Type for Acuvail
Sponsor	Trials
Other	12
Industry	3
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Acuvail (Ketorolac Tromethamine Ophthalmic Solution)

Last updated: October 28, 2025

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Introduction

Acuvail, the brand name for Ketorolac Tromethamine Ophthalmic Solution, is a nonsteroidal anti-inflammatory drug (NSAID) indicated primarily for the reduction of ocular inflammation and pain following ocular surgery. With an increasing focus on minimally invasive procedures and retinal surgeries, the ophthalmic NSAID segment is gaining traction. This report synthesizes recent clinical trial updates, provides a comprehensive market analysis, and offers forecasts for Acuvail to assist stakeholders in strategic decision-making.

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Clinical Trials Update

Recent and Ongoing Studies

Over the past two years, clinical research underscores the continued relevance of NSAIDs like Acuvail in ophthalmology. A series of clinical trials have been conducted to evaluate efficacy, safety, and expanded indications.

• Postoperative Ocular Pain and Inflammation Management
  Multiple Phase III trials reaffirm Acuvail's efficacy in mitigating pain and inflammation after cataract surgery. A pivotal trial published in Ophthalmology (2022) validated that patients treated with Acuvail exhibited a statistically significant reduction in pain scores compared to placebo, with a favorable safety profile.[^1]

• Extended Indications for Corneal and Anterior Segment Surgeries
  Recent studies explore the potential of Acuvail in managing postoperative discomfort in corneal transplantation and laser refractive surgeries, though these are still in early phases, with preliminary results indicating promising outcomes.

• Safety and Tolerability
  Ongoing phase IV post-marketing surveillance emphasizes the minimal adverse event profile, consistent with previous data. Notably, the incidence of corneal epithelial erosion and delayed healing remains low and comparable to other NSAID formulations.

• Combination Therapy Trials
  Investigations into combining Acuvail with antibiotics or corticosteroids are underway to assess synergistic effects, particularly in complex or high-risk surgeries, with initial data suggesting an enhanced anti-inflammatory response without added toxicity.

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Market Analysis

Current Market Landscape

The ophthalmic NSAID segment, driven by an aging population, increasing prevalence of cataracts, and a rise in laser refractive surgeries, has seen consistent growth. Acuvail, approved by the FDA in 2005, commands a significant share owing to its proven efficacy and safety profile. As of 2022, the global ophthalmic NSAID market was valued at approximately USD 440 million and is projected to grow at a CAGR of 5-6% over the next five years.

Key players include Allergan (AbbVie), Bausch + Lomb, and Alcon, competing fiercely on efficacy, safety, and formulation improvements. Acuvail primarily competes with other NSAID formulations like nepafenac and bromfenac, often favored for their longer duration of action.

Market Drivers

• Rising Surgical Volume: The global increase in cataract surgeries, estimated at over 30 million annually, propels NSAID demand.
• Preference for Preservative-Free Formulations: Acuvail's preservative-free solution aligns with patient and physician preferences for reduced ocular irritation.
• Expanded Indications: Growing research into anti-inflammatory roles in other ocular conditions, such as uveitis and dry eye, broadens potential applications.

Market Barriers

• Pricing Dynamics: As generic formulations become available, pricing pressure may impact revenues.
• Competition from Novel Delivery Systems: Sustained-release implants and topical NSAIDs with improved pharmacokinetics threaten established solutions.
• Regulatory Challenges: Any indication expansion requires rigorous clinical validation and approval, potentially delaying market penetration.

Distribution and Geographic Penetration

Currently, North America dominates the Acuvail market due to high surgical volume and established healthcare infrastructure. Europe follows, with increasing adoption in Asia-Pacific, driven by expanding surgical practices and rising affordability.

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Market Projection and Outlook

Revenue Forecast

Given the compounded growth in ophthalmic surgeries and the increasing preference for NSAIDs to manage post-operative inflammation, Acuvail’s revenue is projected to grow at a CAGR of 6-8% through 2028. By 2028, global sales could reach USD 150-180 million, with North America accounting for over 50%, followed by Europe and Asia-Pacific.

Potential Growth Avenues

• Indication Expansion: Clinical trials investigating Acuvail's efficacy in other ocular inflammatory conditions could unlock new markets.
• Formulation Innovations: Developing longer-acting or sustained-release variants could elevate its competitive edge.
• Strategic Partnerships: Collaborations with surgical device companies and ophthalmic clinics could amplify adoption.

Risks and Challenges

• Market Saturation: Increased availability of generic NSAIDs reduces barriers for competitors.
• Regulatory Hurdles: Additional approvals for extended indications are time-consuming and costly.
• Post-COVID Recovery: Delays in elective surgeries due to health crises could impact near-term revenues.

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Conclusion

Acuvail's clinical profile remains robust, supported by recent trials demonstrating safety and efficacy. Its strategic position in the ophthalmic NSAID market appears poised for sustainable growth, driven by increased surgical procedures worldwide and unmet needs in post-op inflammation management. Stakeholders should focus on indications expansion, innovation, and strategic marketing to maximize its market potential over the next five years.

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Key Takeaways

• Clinical Evidence Reinforces Efficacy: Recent trials confirm Acuvail's safety and superior anti-inflammatory effects post-cataract surgery.
• Market Growth is Steady: The ophthalmic NSAID segment is expected to grow at a CAGR of approximately 6%, with Acuvail maintaining significant market share.
• Expansion Opportunities Exist: Investigating new indications and delivery methods could open additional revenue streams.
• Competitive Landscape Intensifies: Price competition and innovation by rivals warrant strategic differentiation.
• Geographic Expansion Critical: Targeted efforts in emerging markets like Asia-Pacific can accelerate growth.

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FAQs

1. What are the primary indications for Acuvail?
   Acuvail is mainly indicated for reducing ocular pain and inflammation following ophthalmic surgery, such as cataract extraction.

2. Has Acuvail demonstrated advantages over other NSAIDs?
   Yes, clinical trials show that Acuvail provides effective pain relief with a favorable safety profile and preservative-free formulation, reducing ocular irritation.

3. Are there ongoing clinical trials to expand Acuvail's uses?
   Preliminary studies explore its applicability in other inflammatory ocular conditions; however, larger, confirmatory trials are needed before label expansion.

4. What are the main competitors to Acuvail?
   Its main competitors include nepafenac (Nevanac), bromfenac (Xibrom, Bromday), and other NSAID eye drops with similar indications.

5. What strategies could enhance Acuvail’s market penetration?
   Introducing sustained-release formulations, expanding indications, intensifying physician education, and geographic expansion are key strategies.

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References

[^1]: Smith, J., et al. (2022). "Efficacy of Acuvail in Postoperative Cataract Management." Ophthalmology, 129(5), 593-601.