CLINICAL TRIALS PROFILE FOR LOTEMAX SM

All Clinical Trials for LOTEMAX SM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00705159 ↗	Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis	Completed	Bausch & Lomb Incorporated	Phase 4	2008-06-01	The objective of this study is to evaluate the safety and effectiveness of Zylet in comparison with Lotemax, Tobramycin and the vehicle of Zylet for the treatment of blepharoconjunctivitis in pediatric subjects.
NCT00407043 ↗	Multicenter, Randomized, Controlled Study of the Effect of Lotemax on Initiation of Dry Eye Treatment With Restasis	Completed	Bausch & Lomb Incorporated	Phase 4	2006-11-01	To evaluate the impact of Lotemax on the initiation of Restasis therapy in patients with dry eye. It is hypothesized that the anti-inflammatory activity of Lotemax may help mitigate the stinging with cyclosporine administration and the dry eye signs and symptoms experienced during the initiation of therapy.
NCT00407043 ↗	Multicenter, Randomized, Controlled Study of the Effect of Lotemax on Initiation of Dry Eye Treatment With Restasis	Completed	Ophthalmic Consultants of Long Island	Phase 4	2006-11-01	To evaluate the impact of Lotemax on the initiation of Restasis therapy in patients with dry eye. It is hypothesized that the anti-inflammatory activity of Lotemax may help mitigate the stinging with cyclosporine administration and the dry eye signs and symptoms experienced during the initiation of therapy.
NCT00366691 ↗	Comparison of Acular LS With Lotemax to Prevent Inflammation After Cataract Surgery and Intraocular Lens Implantation	Completed	Medical University of South Carolina	Phase 4	2006-02-01	The purpose of this study is to compare the effectiveness of Acular LS® and Lotemax® in the prevention of inflammation in the eye after cataract surgery. Acular LS is made by Allergan, Inc. It is a nonsteroidal anti-inflammatory drug (NSAID) and is approved by the Food and Drug Administration (FDA) for use following cataract surgery. Lotemax is made by Bausch & Lomb. It is a steroid and is also approved by the FDA for use following cataract surgery.
NCT00560638 ↗	Loteprednol Etabonate Opthalmic Suspension for the Treatment of Dry Eye	Completed	Bausch & Lomb Incorporated	Phase 2	2005-11-01	This was a single-center, randomized, double-masked, placebo-controlled, parallel-group, 4-visit, CAE (Controlled Adverse Environment) study lasting approximately 4 weeks. Subjects were randomized to receive loteprednol etabonate ophthalmic suspension, 0.5% or placebo (vehicle of loteprednol etabonate ophthalmic suspension, 0.5%) and instructed to dose bilaterally either TID or QID according to randomization.

Clinical Trial Conditions for LOTEMAX SM

Condition Name

Condition Name for LOTEMAX SM
Intervention	Trials
Dry Eye Disease	4
Inflammation	4
Dry Eye	3
Keratoconjunctivitis Sicca	2

Condition MeSH

Condition MeSH for LOTEMAX SM
Intervention	Trials
Dry Eye Syndromes	8
Keratoconjunctivitis Sicca	7
Inflammation	6
Eye Diseases	5

Clinical Trial Locations for LOTEMAX SM

Trials by Country

+

−

Trials by Country for LOTEMAX SM
Location	Trials
United States	19
Brazil	1
Israel	1
Korea, Republic of	1

Trials by US State

+

−

Trials by US State for LOTEMAX SM
Location	Trials
Massachusetts	5
New York	3
New Jersey	2
California	2
Ohio	1

Clinical Trial Progress for LOTEMAX SM

Clinical Trial Phase

Clinical Trial Phase for LOTEMAX SM
Clinical Trial Phase	Trials
Phase 4	12
Phase 3	2
Phase 2	2

Clinical Trial Status

Clinical Trial Status for LOTEMAX SM
Clinical Trial Phase	Trials
Completed	16
Unknown status	3
Enrolling by invitation	1

Clinical Trial Sponsors for LOTEMAX SM

Sponsor Name

Sponsor Name for LOTEMAX SM
Sponsor	Trials
Bausch & Lomb Incorporated	11
Massachusetts Eye and Ear Infirmary	3
Tufts Medical Center	2

Sponsor Type

Sponsor Type for LOTEMAX SM
Sponsor	Trials
Other	18
Industry	14

LOTEMAX SM: Clinical Trials, Market Analysis, and Projections

Introduction to LOTEMAX SM

LOTEMAX SM, formulated as loteprednol etabonate ophthalmic gel 0.38%, is a recent advancement in the treatment of postoperative inflammation and pain following ocular surgery. Developed by Bausch + Lomb, this drug has garnered significant attention for its efficacy and safety profile.

Clinical Trials Overview

The FDA approval of LOTEMAX SM was based on data from two randomized, multicenter, double-masked, parallel-group, vehicle-controlled studies involving 742 patients with postoperative inflammation following cataract surgery[3][4].

Study Design and Outcomes

• These studies evaluated the safety and efficacy of LOTEMAX SM administered three times daily to the affected eye, starting the day after surgery.
• Primary efficacy endpoints included the resolution of anterior chamber cells (ACC) and the absence of pain (Grade 0) at day 8.
• Secondary endpoints included inflammation and pain assessments at different visits, such as day 3[3][4].

Efficacy Results

• The pooled analysis showed that LOTEMAX SM was significantly more effective than the vehicle in resolving ocular inflammation and pain. At day 8, 73% and 76% of patients in the two studies, respectively, achieved complete resolution of ACC compared to 48% and 50% in the vehicle groups[1][3].
• Similarly, 74% and 72% of patients treated with LOTEMAX SM were pain-free at day 8 and day 3, respectively, compared to 49% and 50% in the vehicle groups[3].

Safety Profile

• The studies demonstrated a favorable safety profile for LOTEMAX SM. Only one patient experienced significant intraocular pressure (IOP) elevations ≥10 mm Hg, and there were no treatment-emergent adverse drug reactions occurring in more than 1% of patients[1][3].

Mechanism of Action and Formulation

LOTEMAX SM is formulated using SubMicron technology, which enhances ocular penetration and residence time in anterior segment tissues. This technology allows for a lower concentration of loteprednol etabonate (0.38%) compared to previous formulations, while maintaining or improving efficacy[3][4].

Market Analysis

Current Market Scenario

• LOTEMAX SM has been approved for use in several major markets, including the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. The drug has been positioned as a key treatment option for postoperative inflammation and pain following ocular surgery[2][5].

Market Forecast

• The market for LOTEMAX SM is expected to grow significantly from 2023 to 2032, driven by increasing healthcare spending and the need for effective treatments for acute ocular pain. Forecasted sales data indicate a robust market outlook, with the drug expected to remain a dominant player in the ophthalmic anti-inflammatory market[2][5].

Competitive Landscape

• The competitive landscape for LOTEMAX SM includes other marketed therapies and late-stage emerging therapies. While LOTEMAX SM has a strong position due to its proven efficacy and safety, it will face competition from new therapies focusing on novel approaches to treat ocular pain and inflammation[5].

SWOT Analysis

• Strengths: Proven efficacy, efficient penetration due to SubMicron technology, and a favorable safety profile.
• Weaknesses: Potential for IOP elevations, though rare, and the need for regular monitoring if used for extended periods.
• Opportunities: Growing demand for effective postoperative care, expanding into new markets, and potential applications in other ocular conditions.
• Threats: Emerging competitors, regulatory challenges, and market competition from other anti-inflammatory ophthalmic products[5].

Regulatory Milestones and Developmental Activities

• The FDA approval of LOTEMAX SM in February 2019 marked a significant regulatory milestone. The approval was based on comprehensive clinical trials that demonstrated the drug's efficacy and safety[3][4].
• Ongoing developmental activities include continuous monitoring of safety and efficacy in real-world settings and potential expansion into other ocular indications.

Analysts' Views and Market Projections

Analysts predict that LOTEMAX SM will continue to be a leading treatment for postoperative inflammation and pain due to its clinical benefits and patient compliance. The market is expected to expand as more patients undergo ocular surgeries and as healthcare spending increases globally[2][5].

Forecasted Sales Data

• The forecasted sales data from 2023 to 2032 indicate a steady growth trajectory for LOTEMAX SM, driven by its strong clinical profile and market demand. This growth will be supported by the increasing prevalence of ocular surgeries and the need for effective postoperative care[5].

Key Takeaways

• Clinical Efficacy: LOTEMAX SM has demonstrated significant efficacy in resolving postoperative inflammation and pain following cataract surgery.
• Safety Profile: The drug has a favorable safety profile with minimal adverse effects.
• Market Outlook: Strong market projections indicate continued growth and dominance in the ophthalmic anti-inflammatory market.
• Regulatory and Developmental Activities: Ongoing monitoring and potential expansion into new indications will further solidify LOTEMAX SM's position.

FAQs

Q: What is LOTEMAX SM used for?

A: LOTEMAX SM is used for the treatment of postoperative inflammation and pain following ocular surgery.

Q: What is the formulation of LOTEMAX SM?

A: LOTEMAX SM is a loteprednol etabonate ophthalmic gel 0.38%, formulated using SubMicron technology.

Q: What were the key findings of the clinical trials for LOTEMAX SM?

A: The clinical trials showed that LOTEMAX SM was significantly more effective than the vehicle in resolving ocular inflammation and pain, with a favorable safety profile.

Q: What is the expected market growth for LOTEMAX SM?

A: The market for LOTEMAX SM is expected to grow significantly from 2023 to 2032, driven by increasing healthcare spending and demand for effective postoperative care.

Q: Are there any potential side effects of LOTEMAX SM?

A: While rare, LOTEMAX SM can cause intraocular pressure (IOP) elevations, and patients should be monitored if the drug is used for extended periods.

Sources

1. Proven Efficacy - LOTEMAX SM: Pooled analysis of phase 3 clinical studies.
2. LOTEMAX SM Market Size, Forecast, and Market Insight - 2032: DelveInsight report.
3. Bausch + Lomb Announces FDA Approval Of LOTEMAX SM: PR Newswire.
4. Summary Review - accessdata.fda.gov: FDA Summary Review.
5. United States LOTEMAX SM (Loteprednol Etabonate Ophthalmic Gel) Drug Insights and Market Forecasts Report: GlobeNewswire.