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

Clinical Trial Conditions for ACUVAIL

Condition Name

Condition Name for ACUVAIL
Intervention	Trials
Cataracts	2
Osteoarthritis	1
Pain	1
Age-related Macular Degeneration	1

Condition MeSH

Condition MeSH for ACUVAIL
Intervention	Trials
Cataract	3
Macular Edema	2
Diabetic Retinopathy	2
Osteoarthritis	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
Minnesota	1
Florida	1
Pennsylvania	1
Georgia	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
Recruiting	2
Withdrawn	2

Clinical Trial Sponsors for ACUVAIL

Sponsor Name

Sponsor Name for ACUVAIL
Sponsor	Trials
Allergan	3
Frank A. Bucci, Jr., M.D.	2
University of Louisville	1

Sponsor Type

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

Acuvail (ketorolac tromethamine ophthalmic solution) clinical-trials update, market analysis, and market projection (2026-2035)

Last updated: May 21, 2026

Acuvail is an ophthalmic ketorolac product indicated for reduction of pain and inflammation associated with ophthalmic surgery. It is a well-established, low-growth, low-Rx-volume branded niche product with a long runway for generic competition risk, and limited likelihood of future exclusivity expansion absent new formulation or method-of-use evidence.

What is Acuvail’s current clinical development status and trial pipeline?

Featured snippet answer: No active late-stage clinical-trial program is evident for Acuvail as a standalone branded product; clinical activity is primarily historical or associated with generics/biosimilar-like equivalents and incremental formulation work rather than a new ketorolac “new molecular entity” program.

Are there new Phase 2/3 trials for Acuvail specifically?

No public signal indicates ongoing Phase 2 or Phase 3 trials under an Acuvail-specific brand development program designed to expand indication scope or delivery performance in the US.

What trial activity is most likely tied to Acuvail’s therapeutic space?

Clinical studies in this NSAID/antihyperalgesic ophthalmic segment typically focus on:

• Perioperative pain reduction (cataract and refractive surgery cohorts)
• Post-operative inflammation endpoints (aqueous flare, anterior chamber cell grading)
• Dosing frequency comparisons (QID vs BID vs perioperative-only regimens)
• Safety outcomes (ocular surface irritation, corneal staining, intraocular pressure effects as relevant)

How does trial velocity compare with competing ophthalmic NSAIDs?

Across the segment, comparative evidence has shifted toward:

• head-to-head or non-inferiority studies among generic ketorolac preparations
• combination regimens (NSAID plus steroid/antibiotic standard-of-care)
• real-world persistence and adherence comparisons driven by dosing frequency and patient tolerability

How big is the Acuvail market and where is demand coming from?

Featured snippet answer: Acuvail demand is driven by cataract surgery volumes and surgeon prescribing preference for perioperative pain control, but branded revenue is pressured by generic ketorolac alternatives and retailer formularies.

Primary use setting

• US outpatient ophthalmology surgery centers and hospital outpatient departments
• Cataract surgery is the dominant procedure category; LASIK/PRK volumes also contribute to perioperative pain management but at smaller absolute scale.

Key demand drivers

• Cataract procedure volumes and demographic aging
• Prescribing patterns for NSAID perioperative analgesia
• Post-operative pathway standardization (NSAID + steroid regimens)
• Competitive substitution toward lower-cost generics

Key demand headwinds

• Patent/exclusivity erosion after launch history for the branded product
• High formulary substitutability of ophthalmic ketorolac
• Short “episode-based” utilization tied to surgical timing, which caps prescription durability

Who competes with Acuvail and how strong is the substitution risk?

Featured snippet answer: Substitution risk is high because multiple ketorolac tromethamine ophthalmic generics and other topical NSAIDs compete within the same therapeutic role.

Competitive set (therapeutic alternatives)

• Other topical NSAIDs used for perioperative pain and inflammation (class competition)
• Generic ketorolac tromethamine ophthalmic solutions (direct substitution by formulation and dosing equivalence)

What drives competitive switching?

• Wholesale acquisition cost and pharmacy benefit manager tiering
• Patient out-of-pocket costs at the pharmacy counter
• Prescriber habituation to generic ketorolac SKUs that fit dosing frequency and tolerability

What is Acuvail’s pricing and reimbursement profile?

Featured snippet answer: As a mature, off-patent branded niche product, Acuvail pricing is typically constrained by generic reference pricing dynamics in ophthalmology pharmacy channels.

Where branded pricing pressure shows up

• PBM contracting and formulary status for perioperative ophthalmic NSAIDs
• Retail and mail-order substitution behavior
• Tender or group purchasing dynamics for outpatient surgical centers

Acuvail market projection: what is the revenue forecast and CAGR outlook (2026-2035)?

Featured snippet answer: For 2026-2035, Acuvail’s branded revenue is projected to remain stable-to-down in nominal terms, with low single-digit to mid single-digit CAGR declines as generic substitution persists and patient episodes remain procedure-volume driven.

Base-case revenue trajectory

• 2026-2028: gradual decline from ongoing generic substitution and channel contracting
• 2029-2035: flattening at a lower branded share level if Acuvail maintains at least partial formulary coverage in cataract surgery pathways

Three-scenario projection framework

• Downside (faster formulary loss): branded revenue declines at a higher single-digit CAGR as substitution accelerates
• Base-case (moderate persistence): branded revenue declines at low-to-mid single-digit CAGR, stabilizing late period
• Upside (channel retention): smaller declines if specialty pharmacy coverage and surgeon routines retain branded usage

What could change the projection

• A meaningful relaunch via a differentiated formulation (not evidenced by a current active pipeline)
• Reimbursement shifts that re-expand branded coverage
• A major change in perioperative NSAID pathway standards (unlikely given established standards)

Does Acuvail have new formulation or lifecycle opportunities that could extend demand?

Featured snippet answer: Lifecycle upside would require evidence and regulatory clearance for a materially differentiated formulation, dosing convenience, or expanded perioperative regimen. Current public indications do not show a strong, time-bound pathway for such an extension.

Likely lifecycle levers in ophthalmic NSAIDs

• Reduced dosing frequency while preserving efficacy
• Vehicle or preservative system changes that improve ocular surface tolerability
• Combination fixed-dose products (rare in ketorolac segment)
• Device-assisted delivery (uncommon for ketorolac aqueous solutions)

Key takeaways

• Acuvail is a mature ketorolac ophthalmic niche product with no clear public late-stage branded expansion program signal.
• Demand is primarily tied to cataract surgery episodes and surgeon perioperative analgesia routines.
• Market outlook 2026-2035 is stable-to-down as generic substitution continues and branded share is pressured by pharmacy contracting dynamics.
• Upside requires a differentiated lifecycle move, which is not evidenced by an active clinical expansion program.

FAQs

1. Is Acuvail replacing older ophthalmic NSAIDs after cataract surgery?
   Substitution is generally lateral within perioperative NSAID roles, with generic ketorolac and other topical NSAIDs competing on cost and dosing convenience.

2. What clinical endpoints matter most for ophthalmic ketorolac perioperative trials?
   Pain and inflammation endpoints include anterior chamber cell/flare grading, aqueous flare, corneal staining, and time-windowed post-op pain scoring.

3. What is the biggest market risk for Acuvail in the US?
   Formulary tiering and continued substitution to generic ketorolac tromethamine ophthalmic solutions.

4. How does dosing frequency impact market share in ophthalmic NSAIDs?
   Less frequent dosing can improve adherence and retention, shifting share toward products that align with surgeon preference and patient tolerability.

5. Can new indications materially change Acuvail’s revenue trajectory?
   Yes, but only if clinically validated with regulatory clearance. No clear evidence of new indication expansion for Acuvail is indicated in the current public view.

References

1. American Academy of Ophthalmology (AAO). Preferred Practice Patterns and perioperative inflammation/pain management guidance (accessed via AAO resources).
2. FDA. Drug approval packages and prescribing information for Acuvail (ketorolac tromethamine ophthalmic solution) (FDA label access).
3. NIH ClinicalTrials.gov. Ketorolac ophthalmic NSAID perioperative trial search results and study listings (accessed via ClinicalTrials.gov).