CLINICAL TRIALS PROFILE FOR MAXIDEX

All Clinical Trials for Maxidex

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00258245 ↗	Arsenic Trioxide and Ascorbic Acid Combined With Bortezomib, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia	Completed	National Cancer Institute (NCI)	Phase 1	2005-05-01	RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Ascorbic acid may help arsenic trioxide work better by making cancer cells more sensitive to the drug. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. Giving arsenic trioxide and ascorbic acid together with bortezomib, thalidomide, and dexamethasone may stop the growth of and kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide when given together with ascorbic acid, bortezomib, thalidomide, and dexamethasone in treating patients with relapsed or refractory multiple myeloma or plasma cell leukemia.
NCT00258245 ↗	Arsenic Trioxide and Ascorbic Acid Combined With Bortezomib, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia	Completed	Barbara Ann Karmanos Cancer Institute	Phase 1	2005-05-01	RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Ascorbic acid may help arsenic trioxide work better by making cancer cells more sensitive to the drug. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. Giving arsenic trioxide and ascorbic acid together with bortezomib, thalidomide, and dexamethasone may stop the growth of and kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide when given together with ascorbic acid, bortezomib, thalidomide, and dexamethasone in treating patients with relapsed or refractory multiple myeloma or plasma cell leukemia.
NCT00266838 ↗	Prevention of Docetaxel Induced Dacryostenosis	Completed	Universitaire Ziekenhuizen Leuven	Phase 1	2006-07-01	The antineoplastic agent Docetaxel (Taxotere®) is approved for the treatment of patients with metastatic and locally advanced breast cancer and other malignancies. There are 2 frequently used schedules of treatment with Docetaxel. Docetaxel can be administered every 3 weeks or in a weekly regimen. The efficacy seems to be similar but the toxicity profile changes. In the standard 3-weekly Docetaxel regimen the dose-limiting side effect is myelosuppression, while in the weekly regimen there is only a mild myelosuppression. On the other hand, weekly Docetaxel has a side effect that is rare in the 3-weekly schedule: epiphora (= tearing eye) caused by dacryostenosis. The underlying mechanism of dacryostenosis induced by weekly Docetaxel is fibrosis of the lacrimal puncta and canaliculi. Docetaxel has been reported to be secreted in the lacrimal tears. Direct contact between Docetaxel containing tears and the epithelial lining causes chronic inflammation of the mucosa and ultimately fibrosis of the most narrow part of the lacrimal outflow system i.e. the lacrimal puncta and canaliculi. A surgical treatment is possible for dacryostenosis. In case of subtotal stenosis of the lacrimal canaliculi, silicone intubation of the canaliculi is performed in order to prevent further closure. In the case of complete stenosis, placement of a permanent pyrex glass tube of Jones is required. To our knowledge, there is no primary prevention for Docetaxel induced dacryostenosis. The rationale of this randomized double blind interventional study is to investigate the efficacy of corticosteroid versus artificial tears topical eye treatment in patients on a weekly Docetaxel regimen in prevention of dacryostenosis. The dacryotoxic agent Docetaxel in the lacrimal tears will be washed away by the repetitive use of eye drops. In addition, eye drops containing corticosteroids have an anti-inflammatory effect and may further prevent the formation of fibrosis. A new treatment protocol will be investigated. Two different commercially available eye drops will be compared: dexamethasone sodium phosphate (Maxidex®, Alcon) in one eye of the patient and artificial tears (Lacrystat®, Viatris) in the other eye of the same patient. The study period will start with topical eye treatment from day 1 of cycle 1 and will continue during the administration of chemotherapy, with a final analysis at 26 weeks.

Clinical Trial Conditions for Maxidex

Condition Name

Condition Name for Maxidex
Intervention	Trials
Multiple Myeloma	6
Allergic Conjunctivitis	3
Lymphoma	3

Condition MeSH

Condition MeSH for Maxidex
Intervention	Trials
Multiple Myeloma	12
Neoplasms, Plasma Cell	11
Leukemia	4

Clinical Trial Locations for Maxidex

Trials by Country

Trials by Country for Maxidex
Location	Trials
United States	74
Brazil	12
Belgium	3
Canada	2
Poland	2

Trials by US State

Trials by US State for Maxidex
Location	Trials
Michigan	9
Massachusetts	8
Florida	6
New York	5
Minnesota	5

Clinical Trial Progress for Maxidex

Clinical Trial Phase

Clinical Trial Phase for Maxidex
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	1
Phase 2	16

Clinical Trial Status

Clinical Trial Status for Maxidex
Clinical Trial Phase	Trials
Completed	12
Terminated	6
Recruiting	5

Clinical Trial Sponsors for Maxidex

Sponsor Name

Sponsor Name for Maxidex
Sponsor	Trials
Dana-Farber Cancer Institute	6
Alcon Research	5
Millennium Pharmaceuticals, Inc.	4

Sponsor Type

Sponsor Type for Maxidex
Sponsor	Trials
Other	39
Industry	25
NIH	4

MAXIDEX: Clinical Trials, Market Analysis, and Projections

Introduction to MAXIDEX

MAXIDEX, also known as dexamethasone ophthalmic suspension 0.1%, is a corticosteroid eye drop used to treat various inflammatory and allergic conditions of the eye. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Combined Formulations

A significant clinical trial compared the efficacy and safety of a combined moxifloxacin and dexamethasone formulation (Vigadexa) against conventional treatment using separate moxifloxacin (Vigamox) and dexamethasone (Maxidex) eye drops. The study, conducted in Brazil, involved 139 patients undergoing phacoemulsification and intraocular lens (IOL) implantation. The results showed that the combined formulation was as effective as the conventional treatment in preventing infection and controlling inflammation after surgery[1].

Other Clinical Studies

Another clinical trial, though not specifically focused on MAXIDEX alone, involved comparing eye drops of combined levofloxacin and dexamethasone. This international, multicenter, randomized study aimed to assess the efficacy and safety of these combined eye drops. While the details of this trial are not exclusively about MAXIDEX, it highlights the ongoing research into combined corticosteroid and antibiotic formulations, which can include dexamethasone[4].

Market Analysis

Current Market Size

The U.S. ophthalmic drugs market, which includes MAXIDEX, was estimated to be around USD 15.53 billion in 2023. This market is anticipated to grow at a CAGR of 7.4% from 2024 to 2030, driven by the increasing prevalence of eye-related disorders and the aging population[5].

Market Segments

The anti-VEGF agents segment currently holds a dominant revenue share in the ophthalmic drugs market, but corticosteroids like MAXIDEX remain crucial for treating inflammatory conditions. The release of MAXIDEX, along with other ophthalmic drugs like nepafenac ophthalmic suspension, has contributed to the market growth[3][5].

Key Players

Companies such as Alcon Laboratories (UK) Ltd., which markets MAXIDEX, play a significant role in the ophthalmic drugs market. These companies are continually innovating and expanding their product portfolios to meet the growing demand for ophthalmic treatments[4].

Market Projections

Growth Rate

The U.S. ophthalmic drugs market, including MAXIDEX, is projected to grow significantly over the next few years. With a CAGR of 7.4% from 2024 to 2030, the market is expected to reach around USD 33.51 billion by 2030[5].

Driving Factors

The growth of the market is driven by several factors, including:

• Aging Population: The steady increase in the aging population in the U.S. contributes to a higher incidence of eye-related disorders.
• Increasing Prevalence of Eye Disorders: Conditions such as diabetic macular edema, diabetic retinopathy, and wet age-related macular degeneration are becoming more prevalent, increasing the demand for ophthalmic drugs[5].

Competitive Landscape

The market for ophthalmic drugs is competitive, with various players introducing new products and formulations. For example, Regeneron Pharmaceuticals has presented positive long-term results for EYLEA HD (aflibercept) Injection 8 mg, which competes in the same therapeutic area as MAXIDEX[5].

Future Outlook

Innovations and Clinical Trials

The future outlook for MAXIDEX and similar ophthalmic drugs is promising, with ongoing clinical trials and innovations. Companies are planning to initiate new clinical trials, such as the dry eye chamber clinical trial mentioned, which could lead to new indications and expanded use of these drugs[3].

Regulatory and Reimbursement Scenario

The regulatory and reimbursement landscape is crucial for the market growth of ophthalmic drugs. Positive outcomes from clinical trials and favorable regulatory decisions can significantly impact the market share and revenue of MAXIDEX and other similar drugs[2].

Key Takeaways

• Efficacy and Safety: MAXIDEX has been shown to be effective and safe in clinical trials, especially when combined with antibiotics.
• Market Growth: The U.S. ophthalmic drugs market is projected to grow significantly, driven by the aging population and increasing prevalence of eye disorders.
• Competitive Landscape: The market is competitive, with several key players introducing new products and formulations.
• Future Outlook: Ongoing innovations and clinical trials are expected to expand the use and indications of MAXIDEX and similar drugs.

FAQs

What is MAXIDEX used for?

MAXIDEX, or dexamethasone ophthalmic suspension 0.1%, is used to treat various inflammatory and allergic conditions of the eye.

What were the findings of the clinical trial comparing combined moxifloxacin and dexamethasone formulations?

The trial found that the combined formulation was as effective as conventional treatment in preventing infection and controlling inflammation after cataract surgery[1].

What is the projected growth rate of the U.S. ophthalmic drugs market?

The U.S. ophthalmic drugs market is projected to grow at a CAGR of 7.4% from 2024 to 2030[5].

Who are the key players in the ophthalmic drugs market?

Key players include Alcon Laboratories (UK) Ltd., Regeneron Pharmaceuticals, and other companies involved in the development and marketing of ophthalmic drugs[3][5].

What are the driving factors for the growth of the ophthalmic drugs market?

The growth is driven by the aging population, increasing prevalence of eye disorders, and ongoing innovations in ophthalmic treatments[5].

Sources

1. Efficacy and tolerability of a combined moxifloxacin/dexamethasone eye drops: PubMed.
2. Dexamethasone Acetate Market to see Huge Growth by 2025: OpenPR.
3. US Ophthalmic Drugs Market Size and Growth: Nova One Advisor.
4. EU Clinical Trials Register: EU Clinical Trials Register.
5. U.S. Ophthalmic Drugs Market Size | Industry Report, 2030: Grand View Research.