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
Lymphoma	3
Allergic Conjunctivitis	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

Last updated: July 27, 2026

MAXIDEX (dexamethasone ophthalmic) clinical trials update, market analysis, and projection

MAXIDEX is a topical ophthalmic corticosteroid product containing dexamethasone. It is used for steroid-responsive inflammatory conditions of the eye, including postoperative inflammation and other ocular inflammatory disorders. Public clinical-trials reporting for “MAXIDEX” specifically is limited; the product’s market position is therefore driven more by regulatory status, generic competition in dexamethasone ophthalmics, and channel mix than by an identifiable late-stage development program under the MAXIDEX brand.

Because “MAXIDEX” is a brand name applied to multiple dexamethasone ophthalmic presentations, a complete, citation-grade clinical-trials update and forward revenue projection cannot be produced from sufficient reliable sources in a way that isolates the brand-specific product, its strength and dosage form, and the current FDA and Orange Book landscape.

Are there current clinical trials for MAXIDEX (dexamethasone ophthalmic)?

Featured-answer: No independently verifiable, brand-isolated late-stage clinical trial program can be confirmed from the available public record for “MAXIDEX” as a distinct study sponsor-driven development asset.

What clinical-trials registry entries exist for “MAXIDEX”

• Public listings for “MAXIDEX” tend to reflect:
  • Generic use in comparator arms, background therapy, or historical standard-of-care references
  • Older studies predating current registry completeness
  • Non-brand-specific “dexamethasone ophthalmic” research that does not map cleanly to today’s MAXIDEX formulations or strengths

Which endpoints typically appear in dexamethasone ophthalmic studies

Where trials exist for dexamethasone eye drops, studies commonly track:

• Conjunctival hyperemia and anterior chamber cells
• Corneal staining or anterior segment inflammation scores
• Inflammation resolution timing post-surgery (cataract or refractive procedures)
• Intraocular pressure changes and steroid response risks

What is the current market size for dexamethasone ophthalmic products and how does MAXIDEX fit?

Featured-answer: MAXIDEX competes within the broader dexamethasone ophthalmic and corticosteroid eye-drop segment, which is shaped by generic availability, payer preference, and formulary tendering. Brand-level market share for MAXIDEX cannot be produced from sufficient source material here without risk of mixing strength/dosage-form segments.

Market drivers

• High volume of cataract and other anterior segment surgeries in markets with large Medicare/managed-care populations
• Steroid demand for postoperative inflammation control
• Ongoing use of topical corticosteroids for noninfectious ocular inflammation

Market constraints

• Generic penetration in dexamethasone ophthalmics
• Substitution at the pharmacy level for therapeutically equivalent dexamethasone products
• Formulary dynamics that favor WAC compression and multi-source tendering

What is the revenue projection for MAXIDEX through 2030?

Featured-answer: A brand-isolated revenue projection through 2030 for MAXIDEX cannot be produced in a citation-grade manner from sufficient source data that ties:

1. the MAXIDEX brand label,
2. the specific dexamethasone ophthalmic presentation (solution versus suspension, strength),
3. and the brand’s current U.S. net revenue base versus category-level demand.

Projection logic used for dexamethasone ophthalmics (category-level framework)

Where investors model these categories, projections typically follow:

• Surgical procedure growth (cataract volume)
• Share of prescriptions routed to topical steroid regimens
• Price compression due to generic competition
• Switching and formulary retention cycles

How does MAXIDEX compare with other ophthalmic corticosteroids?

Featured-answer: MAXIDEX is a dexamethasone corticosteroid. It competes against:

• Other corticosteroids (prednisolone acetate, loteprednol etabonate, fluorometholone, rimexolone)
• Combination products where applicable (steroid plus antibiotic for postoperative settings)

Differentiation dimensions that affect uptake

• Steroid potency and dosing frequency tolerance
• Ocular surface tolerability and viscosity-related drop comfort
• Prescriber familiarity and pharmacy supply contracts

What formulations are used for MAXIDEX and what does that mean for competitive risk?

Featured-answer: MAXIDEX is dexamethasone ophthalmic used in steroid-responsive ocular inflammation. Competitive risk is highest where:

• Generic dexamethasone ophthalmic equivalents are available at scale
• Multiple strengths or presentations are substituted interchangeably within formularies

Formulation and substitution

• Solutions and suspensions can differ in:
  • Suspension settling and dosing technique requirements
  • Perceived onset characteristics
  • Patient adherence impacts
• In tendered formularies, courts and pharmacy buyers often treat equivalent corticosteroid regimens as substitutable unless differences are clinically mandated

What patents protect MAXIDEX and when do they expire?

Featured-answer: A MAXIDEX-specific patent estate cannot be produced here because the brand-to-Orange-Book mapping requires authoritative listing data by NDA and presentation (strength/dosage form). Without that, expiration timelines would be incomplete and risk mixing unrelated dexamethasone ophthalmic entries.

Why patent mapping matters for ophthalmic generics

Dexamethasone eye products often have:

• Multiple patents across formulation, method-of-treatment, and packaging
• Multiple NDA/BLA presentations and corresponding listing differences
• Separate exclusivities and patent-tail effects by submission pathway

What is the Orange Book status of MAXIDEX (dexamethasone ophthalmic)?

Featured-answer: Orange Book status for MAXIDEX cannot be stated here without presentation-level identification of the relevant NDA(s). Generic substitution and Paragraph IV risk both depend on the exact listing(s).

What generic entry risks exist for MAXIDEX?

Featured-answer: Dexamethasone ophthalmics face ongoing generic substitution risk. Brand-level incremental risk depends on the remaining exclusivity and listed patents for each specific MAXIDEX presentation. A brand-specific assessment cannot be produced without Orange Book/NDA mapping.

What FDA regulatory milestones affect MAXIDEX demand?

Featured-answer: Demand is mainly influenced by:

• Ongoing supply stability
• Any label updates affecting steroid response warnings, dosing regimens, or postoperative indications
• Drug pricing and coverage tier placement

A citation-grade milestone timeline for MAXIDEX brand requires NDA-level FDA actions tied to the specific presentation.

Commercial outlook: how prescription and channel dynamics shape MAXIDEX

Featured-answer: In dexamethasone ophthalmics, commercial performance is less tied to branded clinical differentiation and more tied to:

• Formulary placement and pharmacy substitution
• Contract pricing
• Availability continuity
• Competitive intensity from multi-source dexamethasone generics

Key commercial levers

• Managed care formulary strategy for postoperative steroid courses
• Hospital and ambulatory surgery center tendering
• Wholesale distribution continuity and backorder risk management

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Key Takeaways

• MAXIDEX is a dexamethasone ophthalmic corticosteroid used for steroid-responsive ocular inflammation.
• Brand-isolated, current clinical-trials updates for “MAXIDEX” cannot be produced in a citation-grade way from the available public material because studies often reference dexamethasone ophthalmics without mapping to the MAXIDEX brand presentation.
• Market outlook for dexamethasone ophthalmics is primarily driven by generic competition, procedure volume, and formulary/channel dynamics rather than brand-specific late-stage development.
• A definitive patent, Orange Book status, and brand-specific revenue projection cannot be produced without exact NDA/presentation mapping for MAXIDEX.

FAQs

1. Is MAXIDEX the same as generic dexamethasone eye drops?
2. Do dexamethasone ophthalmic products have differences in safety for intraocular pressure increases?
3. Which ophthalmic steroid is most commonly substituted for MAXIDEX on formularies?
4. How does cataract surgery volume translate into demand for topical corticosteroids?
5. What role do hospital formularies and ambulatory surgery center contracts play in ophthalmic steroid sales?

References (APA)

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. (Accessed via FDA database).