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).
NCT02242201 ↗	Total Hip Arthroplasty (THA) Lumbar Plexus Verses Periarticular	Completed	Mayo Clinic	Phase 4	2014-09-01	Total hip arthroplasty is a one of the most commonly performed surgical procedures with increasing numbers anticipated over the next several decades. The purpose of this study was to find a better way to make patients comfortable after their hip surgery. Three different ways of providing pain relief were compared, a peripheral nerve block in the lower back outside of the spinal space (using bupivacaine, a numbing medicine), or injections around the hip joint with one of two different medicines, either Ropivacaine or Liposomal Bupivacaine (Exparel®).

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
Retinal Vein Occlusion	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
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
Vanderbilt University	1

Sponsor Type

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

ACUVAIL: Clinical Trial Landscape, Market Trajectory, and Patent Considerations

Last updated: February 19, 2026

ACUVAIL (diclofenac ophthalmic solution) 0.05% is approved for the treatment of postoperative inflammation and pain following cataract surgery. The drug, developed by KalVista Pharmaceuticals, has a patent portfolio that is critical to its market exclusivity and competitive positioning. Recent clinical trial data and market analysis indicate sustained demand and potential for expanded indications, while patent expirations and generic competition represent future challenges.

What is the Current Clinical Trial Status of ACUVAIL?

ACUVAIL (diclofenac ophthalmic solution) 0.05% is approved by the U.S. Food and Drug Administration (FDA) for the indication of treating postoperative inflammation and pain following cataract surgery [1]. As of current reporting, no new Phase II or Phase III clinical trials for ACUVAIL for this primary indication are actively recruiting or being published in major medical journals or clinical trial registries that would suggest a significant expansion or modification of its approved use in this area.

However, the landscape for ophthalmic anti-inflammatory drugs is dynamic. Research continues into alternative formulations and delivery mechanisms for NSAIDs like diclofenac. While specific ACUVAIL trials are not prominent, the broader field is exploring:

• Novel Formulations: Development of sustained-release formulations, potentially reducing the frequency of dosing.
• Combination Therapies: Investigations into combining diclofenac with other agents to enhance efficacy or address specific inflammatory pathways.
• New Indications: Exploration of diclofenac for other ophthalmic inflammatory conditions beyond post-operative use, though ACUVAIL's current approval is specific.

The absence of new large-scale trials for ACUVAIL in its approved indication suggests a focus on maintaining its current market position and leveraging its established efficacy and safety profile. Manufacturers of generic versions of diclofenac ophthalmic solutions are also active, which influences market dynamics independent of novel ACUVAIL trials.

What is the Market Size and Projection for ACUVAIL?

The market for ophthalmic anti-inflammatory drugs, particularly those used post-cataract surgery, is substantial. ACUVAIL competes within this segment, primarily against other NSAIDs and corticosteroid ophthalmic solutions.

Market Drivers:

• Aging Global Population: Increased prevalence of age-related conditions like cataracts drives demand for surgical interventions [2].
• Advancements in Ophthalmic Surgery: Minimally invasive techniques for cataract surgery are becoming more common, leading to quicker recovery times but still requiring effective inflammation and pain management.
• Patient Preference for Pain Management: A clear demand exists for effective postoperative pain relief to improve patient comfort and compliance.

Market Challenges:

• Generic Competition: The expiration of patents for branded ophthalmic NSAIDs, including diclofenac formulations, allows for the introduction of lower-cost generic alternatives. This significantly impacts pricing and market share for branded products.
• Competition from Corticosteroids: Ophthalmic corticosteroids remain a standard of care for postoperative inflammation, and their efficacy is well-established, posing direct competition.
• Reimbursement Policies: Payer policies and formulary decisions can influence prescribing patterns and accessibility of specific medications.

Market Size and Projections (Estimated):

Accurate, real-time market size figures specifically for ACUVAIL are proprietary and not publicly disclosed by KalVista Pharmaceuticals. However, the broader market for ophthalmic anti-inflammatory drugs, encompassing NSAIDs and corticosteroids, is projected to experience steady growth.

• The global ophthalmic drugs market was valued at approximately USD 25 billion in 2022 and is projected to reach over USD 37 billion by 2030, with a compound annual growth rate (CAGR) of around 5.2% [3].
• The segment for anti-inflammatory and anti-allergy ophthalmic drugs is a significant component of this market.
• Within this segment, NSAIDs like diclofenac play a crucial role, particularly for post-operative pain.

Impact of Generic Entry:

The market dynamics for ACUVAIL will be significantly influenced by the presence and market penetration of generic diclofenac ophthalmic solutions. While branded products like ACUVAIL may retain a segment of the market due to brand loyalty, physician preference, or specific formulation advantages, price erosion due to generics is inevitable.

Future Outlook:

The market for ACUVAIL is expected to remain stable in its current indication, supported by the ongoing volume of cataract surgeries. However, growth beyond this core indication would require new clinical development and regulatory approvals. The competitive landscape will continue to be shaped by generic pricing pressures and the development of new therapeutic agents or delivery systems in ophthalmology.

What are the Key Patent Expirations and Intellectual Property Considerations for ACUVAIL?

The intellectual property (IP) strategy surrounding ACUVAIL is critical for its commercial success and defense against generic competition. Patents protect the drug's formulation, method of use, and potentially manufacturing processes.

Key Patent Considerations for Diclofenac Ophthalmic Solutions:

Diclofenac itself is an established molecule, and its use in ophthalmology has been explored for some time. The patent protection for ACUVAIL would typically focus on:

1. Composition of Matter Patents: While unlikely for the active pharmaceutical ingredient (API) diclofenac, patents could cover specific salt forms, polymorphs, or prodrugs if unique and novel.
2. Formulation Patents: This is the most probable area of patent protection for ACUVAIL. Patents would cover the specific concentration (0.05%), excipients, pH, osmolality, viscosity, and manufacturing methods that contribute to the drug's stability, efficacy, and patient tolerability [4]. These patents are crucial for distinguishing a branded product from generic versions.
3. Method of Use Patents: Patents protecting the use of diclofenac ophthalmic solution for specific indications, such as post-operative inflammation and pain following cataract surgery.
4. Manufacturing Process Patents: Patents covering novel or efficient methods of synthesizing or formulating the ophthalmic solution.

Patent Expirations:

The patent landscape for diclofenac ophthalmic solutions is complex and spans multiple patents, some of which may have already expired or are nearing expiration. Generic manufacturers actively monitor these expirations to introduce their products.

• Generic Entry: Generic versions of diclofenac ophthalmic solution 0.1% are widely available. While ACUVAIL is 0.05%, the established presence of generics for diclofenac in ophthalmic form indicates a competitive environment.
• Patent Cliff: For branded pharmaceuticals, a "patent cliff" refers to the period when primary patents expire, leading to a sharp decline in revenue due to generic competition. The timing of ACUVAIL's key formulation or method-of-use patent expirations is crucial for market analysts.
• Data Exclusivity: Beyond patent protection, regulatory bodies grant periods of data exclusivity, which prevent generic manufacturers from relying on the innovator's clinical trial data to gain approval for a set period, even if patents have expired.

KalVista Pharmaceuticals' IP Strategy (General Approach):

While specific patent numbers and expiration dates for ACUVAIL are detailed in patent databases and regulatory filings (e.g., FDA Orange Book), the general strategy for a product like ACUVAIL would involve:

• Securing and Maintaining Broad Patent Coverage: Filing for patents on novel formulations and delivery systems.
• Defending Patents: Litigating against suspected patent infringers.
• Extension Strategies: Exploring patent term extensions (PTE) and supplementary protection certificates (SPC) where applicable to regain some of the patent life lost during regulatory review.
• Lifecycle Management: Developing new formulations or combination products to extend market exclusivity beyond the initial product's patent life.

Implications for Investors and R&D:

• Investment Horizon: Investors need to understand the remaining patent exclusivity for ACUVAIL to project revenue streams accurately. The proximity of patent expiries will dictate the risk associated with continued investment in the branded product.
• R&D Focus: For R&D, the patent landscape informs decisions on developing next-generation products. Identifying unmet needs or areas where existing patents are weak can guide the development of new therapies with stronger IP protection.
• Generic Manufacturers: Companies aiming to enter the ACUVAIL market will scrutinize the patent portfolio for any weaknesses or opportunities for non-infringing formulations.

Without access to specific, up-to-the-minute patent filings and their legal status, precise expiration dates are not provided here. However, the understanding that diclofenac ophthalmic solutions are subject to patent challenges and generic competition is fundamental to market analysis.

What are the Potential Future Developments and Market Opportunities for ACUVAIL?

The future trajectory of ACUVAIL is influenced by ongoing advancements in ophthalmology, evolving patient care paradigms, and the competitive landscape.

Potential Future Developments:

1. Expanded Indications:

   • Dry Eye Disease (DED): While ACUVAIL is approved for post-operative inflammation, research into NSAIDs for inflammatory components of dry eye is ongoing. If clinical trials demonstrate efficacy and safety for DED, it could significantly broaden ACUVAIL's market. KalVista Pharmaceuticals has previously explored diclofenac for dry eye, indicating potential interest.
   • Other Ophthalmic Inflammatory Conditions: Potential exploration for other conditions where inflammation plays a key role, such as uveitis or conjunctivitis, pending clinical evidence.

2. Improved Formulations:

   • Sustained-Release Technologies: Development of formulations that offer longer durations of action, potentially reducing the need for multiple daily applications. This could enhance patient compliance and therapeutic outcomes.
   • Enhanced Penetration Formulations: Research into novel excipients or delivery systems that improve the penetration of diclofenac into ocular tissues, potentially leading to greater efficacy at lower concentrations.

3. Combination Therapies:

   • With Antibiotics: For cases where infection risk is a concern post-surgery, fixed-dose combinations could streamline treatment regimens.
   • With Steroids: While often used as alternatives or sequential therapies, novel fixed-dose combinations of NSAIDs and corticosteroids might offer synergistic benefits in specific inflammatory profiles.

4. Geographic Market Expansion:

   • Pursuing regulatory approvals and market entry in regions where ACUVAIL is not yet available, particularly in emerging markets with growing ophthalmic surgery volumes.

Market Opportunities:

• Meeting Unmet Needs in Chronic Ocular Inflammation: If ACUVAIL or its derivatives demonstrate efficacy in chronic inflammatory conditions like DED, it could tap into a large and underserved patient population.
• Leveraging Established Safety Profile: The drug's existing safety data from its approved indication can be a valuable asset when pursuing new indications, potentially streamlining regulatory pathways.
• Partnerships and Licensing: KalVista Pharmaceuticals could explore partnerships with other pharmaceutical companies for co-development, co-promotion, or out-licensing opportunities to expand market reach or accelerate development of new applications.
• Differentiation in a Genericized Market: For branded ACUVAIL, differentiation through superior formulations, patient support programs, or demonstrated real-world evidence of better outcomes compared to generics could maintain market share.

Considerations for Future Development:

• Clinical Trial Design and Execution: Robust clinical trials are essential to demonstrate efficacy and safety for any new indication or formulation. This requires significant investment and time.
• Regulatory Hurdles: Obtaining approval for new indications or significant formulation changes involves navigating complex regulatory processes in different jurisdictions.
• Competitive Landscape: The ophthalmic market is highly competitive, with continuous innovation from both established players and emerging biotechs. Any new development must offer a clear advantage over existing and pipeline therapies.
• Economic Viability: The cost of R&D, manufacturing, and market access must be balanced against the potential market size and pricing power for any new product or indication.

The future opportunities for ACUVAIL lie in its potential to address broader ocular inflammatory needs beyond its current post-operative indication, supported by further research and development of advanced formulations and therapeutic strategies.

Key Takeaways

• ACUVAIL (diclofenac ophthalmic solution) 0.05% is approved for postoperative inflammation and pain following cataract surgery.
• No significant new clinical trials for ACUVAIL in its approved indication are currently prominent; research in the broader ophthalmic NSAID space focuses on novel formulations and combination therapies.
• The market for ophthalmic anti-inflammatory drugs is substantial, driven by an aging population and increased cataract surgeries.
• ACUVAIL faces significant competition from generic diclofenac ophthalmic solutions and other anti-inflammatory agents.
• Intellectual property protection for ACUVAIL primarily resides in its formulation and method of use patents, which are critical for market exclusivity.
• Future opportunities for ACUVAIL may include expanded indications (e.g., dry eye disease), development of improved sustained-release formulations, and exploration of combination therapies.

Frequently Asked Questions

1. Has ACUVAIL been approved for any indications other than post-operative inflammation and pain after cataract surgery? No, as of current FDA approvals, ACUVAIL's indication is limited to treating postoperative inflammation and pain following cataract surgery.

2. When are the key patents for ACUVAIL expected to expire, allowing for generic competition? Specific patent expiration dates for ACUVAIL's core formulation patents require detailed examination of the FDA Orange Book and patent databases. However, the market for diclofenac ophthalmic solutions has seen generic entry for other concentrations, indicating that patent protection for the molecule's ophthalmic use is subject to expiry.

3. What are the primary competitive drugs or drug classes against which ACUVAIL competes? ACUVAIL primarily competes with other non-steroidal anti-inflammatory drugs (NSAIDs) in ophthalmic formulations and ophthalmic corticosteroid solutions, particularly in the management of post-operative inflammation and pain.

4. Are there any ongoing clinical trials exploring new uses or significantly improved formulations of ACUVAIL? While no major public announcements of ongoing large-scale trials specifically for ACUVAIL are prevalent for its approved indication, research into advanced NSAID formulations and their application in broader ocular inflammatory conditions, such as dry eye disease, is an active area in ophthalmology that could potentially involve diclofenac derivatives or novel delivery systems.

5. What is the estimated market size for ACUVAIL specifically, or the broader segment it belongs to? Specific market share and revenue figures for ACUVAIL are not publicly disclosed by KalVista Pharmaceuticals. However, the global ophthalmic anti-inflammatory drug market, within which ACUVAIL operates, is estimated to be a significant multi-billion dollar segment of the overall ophthalmic drugs market, projected for steady growth.

Citations

[1] U.S. Food & Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from [FDA website] (specific link not provided as it is a searchable database).

[2] World Health Organization. (2022). Ageing and health. Retrieved from [WHO website] (general topic source).

[3] Global Market Insights. (2023). Ophthalmic Drugs Market Size, Share & Trends Analysis Report. Retrieved from [Market Research Firm Website] (Report details may vary).

[4] U.S. Patent and Trademark Office. (n.d.). Patent Full-Text and Image Database. Retrieved from [USPTO website] (specific patent search required).