CLINICAL TRIALS PROFILE FOR ACULAR LS

All Clinical Trials for Acular Ls

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00332774 ↗	Nevanac 3-Month Safety Study With QID Dosing	Completed	Alcon Research	Phase 3	2006-02-01	The purpose of this study is to determine the safety of Nevanac 0.1% compared to Acular LS 0.4% and Vehicle in patients treated before cataract surgery and for approximately 90 days following surgery.
NCT00333255 ↗	Nepafenac Opthalmic Suspension 0.1% Compared to Acular LS for Treatment of Inflammation After Cataract Surgery	Completed	Alcon Research	Phase 3	2005-09-01	The purpose of this study is to compare the effectiveness of Nepafenac Ophthalmic Suspension, 0.1% eye drops to Acular LS eye drops, used before and after cataract surgery, for treating inflammation in the eye.
NCT00335439 ↗	Effect of Prophylactic Ketorolac on CME After Cataract Surgery	Completed	Queen's University	N/A	2006-06-01	The study will evaluate the efficacy of prophylactic administration of the topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac tromethamine 0.5% (Acular®) on cystoid macular edema (CME) in patients having undergone cataract surgery. CME is the most frequent cause of decreased vision after uncomplicated cataract surgery and can result in irreversible sight reduction. The investigation will involve a comparison arm and a treatment arm with both sets of patient populations being evaluated for CME with ophthalmologic examinations and optical coherence tomography (OCT) measurements. The objective is to elucidate the role of NSAID drops in preventing CME after cataract surgery.
NCT00347204 ↗	Comparison of Acular LS Versus Nevanac for Pain Control in Eyes Undergoing PRK	Completed	Allergan	Phase 4	2006-01-01	To determine the ability of two topical Nonsteroidal Anti-inflammatory drops (Acular LS & Nevanac) to help control pain following Photorefractive Keratectomy (PRK).
NCT00347204 ↗	Comparison of Acular LS Versus Nevanac for Pain Control in Eyes Undergoing PRK	Completed	Center For Excellence In Eye Care	Phase 4	2006-01-01	To determine the ability of two topical Nonsteroidal Anti-inflammatory drops (Acular LS & Nevanac) to help control pain following Photorefractive Keratectomy (PRK).
NCT00348244 ↗	Ketorolac vs. Steroid in the Prevention of CME	Completed	Innovative Medical	Phase 4	1969-12-31	Evaluate if the incidence of sub clinical CME can be significantly reduced by use of peri-operative Acular LS plus Pred Forte when compared with Pred Forte alone in normal cataract patients.
NCT00348582 ↗	Acular LS vs. Nevanac in Post op Inflammation Following Cataract Surgery	Completed	Innovative Medical	Phase 4	1969-12-31	The purpose of this study is to compare the clinical outcomes, safety and efficacy in patients randomized to receive either ketorolac or nepafanac following cataract surgery.

Clinical Trial Conditions for Acular Ls

Condition Name

Condition Name for Acular Ls
Intervention	Trials
Cataract	8
Pseudoexfoliation Glaucoma	1
Laparoscopic Donor Nephrectomy	1
Renal Calculus	1

Condition MeSH

Condition MeSH for Acular Ls
Intervention	Trials
Cataract	10
Inflammation	3
Glaucoma, Open-Angle	2
Glaucoma	2

Clinical Trial Locations for Acular Ls

Trials by Country

Trials by Country for Acular Ls
Location	Trials
United States	13
Canada	2
Croatia	2
Brazil	2
Greece	1

Trials by US State

Trials by US State for Acular Ls
Location	Trials
Arizona	2
Massachusetts	2
Texas	2
Georgia	1
Minnesota	1

Clinical Trial Progress for Acular Ls

Clinical Trial Phase

Clinical Trial Phase for Acular Ls
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	3
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Acular Ls
Clinical Trial Phase	Trials
Completed	18
Terminated	2
Unknown status	1

Clinical Trial Sponsors for Acular Ls

Sponsor Name

Sponsor Name for Acular Ls
Sponsor	Trials
Mayo Clinic	3
Innovative Medical	3
Alcon Research	2

Sponsor Type

Sponsor Type for Acular Ls
Sponsor	Trials
Other	20
Industry	7

Clinical Trials, Market Analysis, and Projections for Acular LS

Clinical Trials and Efficacy of Acular LS

Indications and Usage

Acular LS (ketorolac tromethamine ophthalmic solution) is specifically indicated for the reduction of ocular pain and burning/stinging following corneal refractive surgery, such as photorefractive keratectomy[1][3].

Clinical Studies

In two double-masked, multi-centered, parallel-group studies, 313 patients who underwent photorefractive keratectomy were treated with either Acular LS 0.4% or its vehicle four times a day for up to 4 days. These studies showed significant differences favoring Acular LS for the reduction of ocular pain and burning/stinging post-surgery[1][3].

Adverse Reactions

The most frequently reported adverse reactions in clinical trials included conjunctival hyperemia, corneal infiltrates, headache, ocular edema, and ocular pain, occurring in approximately 1 to 5% of the study population. Transient stinging and burning on instillation were reported by up to 40% of patients[3].

Combination Therapy

A study evaluating the use of ketorolac (Acular LS) during the induction phase of cyclosporine A (Restasis) therapy for dry eye disease found that the combination improved ocular comfort and reduced corneal staining compared to cyclosporine A monotherapy. This combination may enhance patient compliance and reduce discomfort during the initial weeks of cyclosporine therapy[4].

Market Analysis for Ophthalmic Drugs

Global Market Size and Growth

The global ophthalmic drugs market is projected to reach USD 62.55 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 7.4% during the forecast period from 2024 to 2032. This growth is driven by the increasing prevalence of eye diseases, the availability of various medications, and strategic actions by market participants[2].

Regional Market Dynamics

• North America: Currently the largest market, driven by high consumer awareness and the presence of key international companies.
• Europe: Expected to grow significantly due to increasing drug approvals and launches, as well as regulatory support from the European Medicines Agency.
• Asia-Pacific: Forecasted to grow at a CAGR of 5.65%, driven by a large patient pool, high illness prevalence, and the rise of local businesses[2].

Market Segmentation

The ophthalmic drugs market is segmented by disease type, including dry eye, allergies, glaucoma, infections, retinal disorders, uveitis, and others. The topical segment is the highest contributor, expected to grow at a CAGR of 6.4% during the forecast period. Prescription medications, which include treatments for ocular diseases caused by germs, viruses, dry eye syndrome, glaucoma, and post-surgical inflammations, are also significant contributors, growing at a CAGR of 6.2%[2].

Market Projections for Acular LS

Market Position

Acular LS, as a topical ophthalmic solution, fits into the growing topical segment of the ophthalmic drugs market. Its efficacy in reducing ocular pain and burning/stinging post-surgery positions it as a valuable treatment option within this segment.

Competitive Landscape

The market for ophthalmic drugs is competitive, with various players such as Otsuka Pharmaceutical Co., Ltd., Senju Pharmaceutical Co., Ltd., and Aerie Pharmaceuticals, Inc. launching new products. Acular LS, with its established clinical efficacy, remains a strong contender in the market for post-surgical ocular pain management[2].

Import and Export Trends

According to import data, the global demand for Acular LS has seen a growth rate of 4% over the past year, with 226 shipments imported between March 2023 and February 2024. This indicates a steady demand for the product, although there was a year-on-year decline in February 2024 imports[5].

Key Takeaways

• Clinical Efficacy: Acular LS is effective in reducing ocular pain and burning/stinging following corneal refractive surgery.
• Market Growth: The global ophthalmic drugs market is growing at a CAGR of 7.4%, with the topical segment being a significant contributor.
• Regional Dynamics: North America, Europe, and Asia-Pacific are key regions driving market growth, each with unique drivers and challenges.
• Market Position: Acular LS is well-positioned within the topical ophthalmic segment, with a strong competitive landscape.
• Import Trends: Global demand for Acular LS shows steady growth, though with some fluctuations.

FAQs

What is Acular LS used for?

Acular LS is used for the reduction of ocular pain and burning/stinging following corneal refractive surgery[1][3].

What are the common adverse reactions associated with Acular LS?

Common adverse reactions include conjunctival hyperemia, corneal infiltrates, headache, ocular edema, and transient stinging and burning on instillation[3].

How does Acular LS compare to other treatments in clinical trials?

Acular LS has shown significant efficacy in reducing ocular pain and burning/stinging compared to its vehicle in clinical trials. It also improves ocular comfort when used in combination with cyclosporine A for dry eye disease[1][4].

What is the projected growth rate of the global ophthalmic drugs market?

The global ophthalmic drugs market is projected to grow at a CAGR of 7.4% from 2024 to 2032[2].

Which regions are driving the growth of the ophthalmic drugs market?

North America, Europe, and Asia-Pacific are the key regions driving the growth of the ophthalmic drugs market, each with different growth rates and drivers[2].

What is the significance of the topical segment in the ophthalmic drugs market?

The topical segment is the highest contributor to the ophthalmic drugs market, expected to grow at a CAGR of 6.4% during the forecast period, driven by the availability of various medications administered via the topical route[2].

Sources

1. ACULAR LS™ - accessdata.fda.gov
2. Ophthalmic Drugs Market Size to Grow at a CAGR of 7.4% by 2030 - Straits Research
3. Acular LS (Ketorolac Tromethamine Ophthalmic Solution) - RxList
4. Evaluation of Ketorolac (Acular LS) During the Induction Phase of Cyclosporine a (Restasis) Therapy to Improve Patient Comfort - IOVS
5. Acular Imports in World - Volza.com

Last updated: 2024-12-31