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.

Clinical Trial Conditions for ACUVAIL

Condition Name

Condition Name for ACUVAIL
Intervention	Trials
Cataracts	2
Retinopathy of Prematurity	1
Cystoid Macular Edema, Postoperative	1
Total Hip Arthroplasty	1

Condition MeSH

Condition MeSH for ACUVAIL
Intervention	Trials
Cataract	3
Macular Edema	2
Diabetic Retinopathy	2
Retinal Vein Occlusion	1

Clinical Trial Locations for ACUVAIL

Trials by Country

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

Trials by US State

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−

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
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
National Eye Institute (NEI)	1

Sponsor Type

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

ACUVAIL: Clinical Trials, Market Analysis, and Projections

Clinical Trials Overview

ACUVAIL, a preservative-free formulation of ketorolac tromethamine ophthalmic solution, has undergone extensive clinical trials to evaluate its efficacy and safety in treating pain and inflammation following cataract surgery.

Key Clinical Trials

Two multicenter, randomized, double-masked, parallel group comparison studies (191578-005 and 191578-006) were conducted involving 511 patients. These studies compared the efficacy and safety of ACUVAIL with a vehicle (placebo) group. Here are the key findings:

• Efficacy: ACUVAIL demonstrated significant superiority over the vehicle in clearing anterior chamber inflammation and resolving ocular pain. By day seven, nearly twice as many patients receiving ACUVAIL had an SOIS (summed inflammation score) of zero compared to the vehicle group (32% vs 17%). By day 14, 53% of ACUVAIL patients had cleared anterior chamber inflammation, compared to 26% in the vehicle group[3].
• Safety: The most frequently occurring adverse drug reactions were increased intraocular pressure (IOP) (5.8%), conjunctival hyperemia, eye pain, photophobia, and anterior chamber inflammation. However, these adverse events were generally reversible and did not lead to long-term complications[1].

Adverse Events

The clinical trials highlighted that while ACUVAIL was generally well-tolerated, there were some notable adverse events:

• Increased IOP was more frequent in the ACUVAIL group (5.8%) compared to the vehicle group (1.8%).
• Anterior chamber inflammation led to study discontinuation in 3.6% of patients[1].

Market Analysis

FDA Approval and Market Entry

ACUVAIL received FDA approval in July 2009 for the treatment of pain and inflammation following cataract surgery. This approval marked a significant milestone, given the high frequency of cataract surgeries in the United States, with over 3 million procedures performed annually[3].

Market Positioning

ACUVAIL is positioned as an advanced, preservative-free NSAID, which is a key differentiator in the ophthalmic market. Its twice-daily dosing and optimized tolerability make it a convenient and effective option for managing post-cataract surgery inflammation and pain.

Regulatory Challenges

Despite its clinical success, Allergan faced regulatory challenges related to marketing claims. The company received an Untitled Letter from the DDMAC (Division of Drug Marketing, Advertising, and Communications) for making unsubstantiated superiority claims about ACUVAIL in a journal ad. This led to the immediate cessation of the misleading marketing materials[2].

Market Projections

Ophthalmic Therapeutic Market

The ophthalmic therapeutic drugs market, which includes products like ACUVAIL, is expected to grow significantly. A market research report indicated that the global ophthalmic therapeutic drugs market would experience compound annual growth rates (CAGRs) through 2014, driven by increasing prevalence of eye diseases such as age-related macular degeneration, glaucoma, and diabetic retinopathy[5].

Competitive Landscape

ACUVAIL operates in a competitive landscape with other ophthalmic NSAIDs and therapeutic agents. Key players in the ophthalmic market include Allergan, Alcon/Novartis, and Pfizer, among others. The market is characterized by stringent regulatory pathways and a focus on sustained delivery technologies, which ACUVAIL's preservative-free formulation aligns with[5].

Future Outlook

Given its efficacy and safety profile, ACUVAIL is expected to remain a valuable option for ophthalmic surgeons and patients undergoing cataract surgery. The drug's unique preservative-free formulation and twice-daily dosing convenience are likely to contribute to its market share in the ophthalmic NSAID segment.

Key Takeaways

• Clinical Efficacy: ACUVAIL has demonstrated significant efficacy in clearing anterior chamber inflammation and resolving ocular pain post-cataract surgery.
• Safety Profile: While generally well-tolerated, ACUVAIL can cause increased IOP and other adverse events, which are mostly reversible.
• Market Approval: FDA-approved in 2009, ACUVAIL is a key player in the ophthalmic therapeutic market.
• Regulatory Compliance: Allergan has faced regulatory challenges related to marketing claims, emphasizing the need for accurate and substantiated advertising.
• Market Growth: The ophthalmic therapeutic market is projected to grow, driven by increasing prevalence of eye diseases.

FAQs

Q: What is ACUVAIL used for?

A: ACUVAIL is used for the treatment of pain and inflammation following cataract surgery.

Q: What is the unique feature of ACUVAIL?

A: ACUVAIL is a preservative-free formulation of ketorolac tromethamine ophthalmic solution, which is a key differentiator in the ophthalmic market.

Q: What were the main findings of the clinical trials for ACUVAIL?

A: The clinical trials showed that ACUVAIL was significantly superior to the vehicle in clearing anterior chamber inflammation and resolving ocular pain post-cataract surgery.

Q: What are the common adverse events associated with ACUVAIL?

A: Increased intraocular pressure (IOP), conjunctival hyperemia, eye pain, photophobia, and anterior chamber inflammation are common adverse events.

Q: Did ACUVAIL face any regulatory challenges?

A: Yes, Allergan received an Untitled Letter from the DDMAC for making unsubstantiated superiority claims about ACUVAIL in a journal ad.

Sources

1. PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION: ACUVAIL (ketorolac tromethamine ophthalmic solution) - AbbVie Canada.
2. DDMAC pokes Allergan on eye drop direct mail: MM+M.
3. Allergan Inc. (AGN) Receives FDA Approval For ACUVAIL Ophthalmic Solution: Ophthalmology Web.
4. ACUVAIL Drug Patent Profile: Drug Patent Watch.
5. Reportlinker Adds Ophthalmic Therapeutic Drugs: Technologies and Global Markets: Fierce Pharma.