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Last Updated: December 12, 2025

CLINICAL TRIALS PROFILE FOR OZURDEX


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All Clinical Trials for OZURDEX

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00450801 ↗ R-MACLO-IVAM and Thalidomide in Untreated Mantle Cell Lymphoma Completed University of Miami Phase 2 2004-04-01 RATIONALE: To evaluate the efficacy of a new high intensity chemotherapy regimen with thalidomide maintenance in patients with newly diagnosed mantle cell lymphoma PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy followed by thalidomide works in treating patients with previously untreated mantle cell lymphoma.
NCT01027650 ↗ Safety and Efficacy of AGN208397 in the Treatment of Macular Edema Associated With Retinal Vein Occlusion (RVO) Completed Allergan Phase 1/Phase 2 2010-03-01 This study will evaluate the safety and efficacy of a single intravitreal injection of AGN208397 to treat Macular Edema associated with Retinal Vein Occlusion. This study is being conducted in two stages: Stage 1 will enroll approximately 21 subjects who will receive a single open label intravitreal injection of either 75 ug, 300 ug, 600 ug or 900 ug of AGN208397 and be followed for 12 months post treatment; based on Stage 1 results, Stage 2 will enroll approximately 96 subjects who will receive a single masked intravitreal injection of one of three doses of AGN208397 or Ozurdex® and be followed for 12 months post treatment.
NCT01122511 ↗ Safety and Efficacy of Dexamethasone as Adjunctive Therapy to Ranibizumab in Subjects With Choroidal Neovascularization and Age-Related Macular Degeneration Terminated Allergan Phase 2 2010-08-01 This study will evaluate the safety and efficacy of dexamethasone (OZURDEX®) as adjunctive therapy to ranibizumab (LUCENTIS®) compared with ranibizumab alone in the treatment of patients with choroidal neovascularization secondary to age-related macular degeneration
NCT01231633 ↗ Comparison of Initial Ozurdex (Dexamethasone Implant) to Avastin (Bevacizumab) for Treatment of Macular Edema Caused by Central Retinal Vein Occlusion (CRVO) Completed Long Island Vitreoretinal Consultants N/A 2010-09-01 The purpose of this study is to compare visual improvement and total number of intraocular injections in eyes with macular edema following central retinal vein occlusion (CRVO)after initial treatment with Ozurdex (dexamethasone implant) or Avastin (bevacizumab).
NCT01243086 ↗ OZURDEX in Age Related Macular Degeneration as Adjunct to Ranibizumab Completed Hamilton Health Sciences Corporation Phase 2 2011-03-01 In the Western World, Age Related Macular Degeneration (ARMD) is a leading cause of blindness. This disease was once thought to be a natural part of aging, but recent research has introduced effective treatments. ARMD is related to the body initiating an immune response in the eye, as if responding to an infection. Vision is impacted as ocular tissue becomes inflamed and new blood vessels form at the back of the eye, a process called angiogenesis. In the more severe wet form of ARMD, blood and fluid leak out of the vessels and impair the eye's structure and function. Many studies have shown that ranibizumab, a drug that stops the formation of new blood vessels (an anti-angiogenic agent) can delay damage to the eye and often restore vision. The investigators believe the best drug therapy will also stop the inflammation. OZURDEX, a steroid drug, has shown the potential to effectively reduce inflammation in this application. The investigators aim to investigate if patients receiving a combination treatment of ranibizumab and OZURDEX improve their visual abilities more than those receiving just ranibizumab treatment alone. Secondarily, the investigators will also investigate how often patients receiving each drug therapy regime require re-treatment and how often they experience further vision loss.
NCT01243086 ↗ OZURDEX in Age Related Macular Degeneration as Adjunct to Ranibizumab Completed St. Joseph's Healthcare Hamilton Phase 2 2011-03-01 In the Western World, Age Related Macular Degeneration (ARMD) is a leading cause of blindness. This disease was once thought to be a natural part of aging, but recent research has introduced effective treatments. ARMD is related to the body initiating an immune response in the eye, as if responding to an infection. Vision is impacted as ocular tissue becomes inflamed and new blood vessels form at the back of the eye, a process called angiogenesis. In the more severe wet form of ARMD, blood and fluid leak out of the vessels and impair the eye's structure and function. Many studies have shown that ranibizumab, a drug that stops the formation of new blood vessels (an anti-angiogenic agent) can delay damage to the eye and often restore vision. The investigators believe the best drug therapy will also stop the inflammation. OZURDEX, a steroid drug, has shown the potential to effectively reduce inflammation in this application. The investigators aim to investigate if patients receiving a combination treatment of ranibizumab and OZURDEX improve their visual abilities more than those receiving just ranibizumab treatment alone. Secondarily, the investigators will also investigate how often patients receiving each drug therapy regime require re-treatment and how often they experience further vision loss.
NCT01243086 ↗ OZURDEX in Age Related Macular Degeneration as Adjunct to Ranibizumab Completed McMaster University Phase 2 2011-03-01 In the Western World, Age Related Macular Degeneration (ARMD) is a leading cause of blindness. This disease was once thought to be a natural part of aging, but recent research has introduced effective treatments. ARMD is related to the body initiating an immune response in the eye, as if responding to an infection. Vision is impacted as ocular tissue becomes inflamed and new blood vessels form at the back of the eye, a process called angiogenesis. In the more severe wet form of ARMD, blood and fluid leak out of the vessels and impair the eye's structure and function. Many studies have shown that ranibizumab, a drug that stops the formation of new blood vessels (an anti-angiogenic agent) can delay damage to the eye and often restore vision. The investigators believe the best drug therapy will also stop the inflammation. OZURDEX, a steroid drug, has shown the potential to effectively reduce inflammation in this application. The investigators aim to investigate if patients receiving a combination treatment of ranibizumab and OZURDEX improve their visual abilities more than those receiving just ranibizumab treatment alone. Secondarily, the investigators will also investigate how often patients receiving each drug therapy regime require re-treatment and how often they experience further vision loss.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for OZURDEX

Condition Name

Condition Name for OZURDEX
Intervention Trials
Diabetic Macular Edema 31
Macular Edema 30
Retinal Vein Occlusion 14
Diabetic Retinopathy 5
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Condition MeSH

Condition MeSH for OZURDEX
Intervention Trials
Macular Edema 64
Edema 50
Retinal Vein Occlusion 20
Multiple Myeloma 7
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Clinical Trial Locations for OZURDEX

Trials by Country

Trials by Country for OZURDEX
Location Trials
United States 134
Australia 16
Canada 8
China 8
France 8
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Trials by US State

Trials by US State for OZURDEX
Location Trials
California 14
Florida 12
Texas 11
Maryland 9
Massachusetts 8
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Clinical Trial Progress for OZURDEX

Clinical Trial Phase

Clinical Trial Phase for OZURDEX
Clinical Trial Phase Trials
PHASE4 1
PHASE1 1
Phase 4 27
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Clinical Trial Status

Clinical Trial Status for OZURDEX
Clinical Trial Phase Trials
Completed 46
Recruiting 15
Terminated 11
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Clinical Trial Sponsors for OZURDEX

Sponsor Name

Sponsor Name for OZURDEX
Sponsor Trials
Allergan 42
Johns Hopkins University 4
Postgraduate Institute of Medical Education and Research 3
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Sponsor Type

Sponsor Type for OZURDEX
Sponsor Trials
Other 95
Industry 64
NIH 4
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Clinical Trials Update, Market Analysis, and Projection for OZURDEX (Dexamethasone Intravitreal Implant)

Last updated: October 30, 2025


Introduction

OZURDEX, a biodegradable dexamethasone intravitreal implant, developed by Allergan (now part of AbbVie after acquisition), is a pioneering corticosteroid device approved for the treatment of various ocular conditions, including macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), non-infectious uveitis, and others. Its sustained-release profile offers significant convenience and efficacy in managing chronic ocular inflammations and edema, positioning it distinctively within the ophthalmic therapeutics landscape. This analysis explores the latest clinical trial developments, evaluates the current market dynamics, and projects the future trajectory of OZURDEX.


Clinical Trials Update

Recent and Ongoing Clinical Investigations

While OZURDEX has established an extensive history of clinical use, ongoing trials aim to expand its indications, optimize dosing regimens, and improve safety profiles:

  1. New Indications and Expanded Use

    • Retinal Vein Occlusion (RVO) and Diabetic Macular Edema (DME): Trials continue to explore extended efficacy durations beyond the existing 3- to 6-month interval. For instance, the RHINE and REVEAL studies evaluate 6-month and 12-month dosing intervals to determine if efficacy and safety are maintained with reduced injection frequency, potentially improving patient compliance and reducing adverse events.
  2. Combination Therapy Trials

    • Combining OZURDEX with anti-VEGF agents (e.g., Lucentis, Eylea) to assess synergistic effects on refractory edema; early results suggest improved visual acuity and macular thickness reduction compared to monotherapy.
  3. Safety and Tolerability Studies

    • Ongoing observational studies monitor intraocular pressure (IOP) elevation, cataract progression, and infection risks associated with sustained-release corticosteroid implants. These aim to delineate patient subgroups most likely to benefit with minimal adverse effects.
  4. Innovative Formulations and Delivery Techniques

    • Clinical trials investigating next-gen biodegradable implants or sustained-release platforms seek to extend therapeutic duration, potentially revolutionizing treatment paradigms.

Key Highlights from Recent Data

  • The PROVIDER study reinforced the safety profile of OZURDEX, noting manageable IOP increases primarily in patients with pre-existing glaucoma.
  • The HORIZON trial demonstrated sustained visual and anatomical improvements for up to 6 months, with a manageable safety profile, supporting biannual retreatment in certain indications.

Market Analysis

Current Market Landscape

OZURDEX holds a prominent position within the ophthalmic corticosteroid segment, competing primarily with Iluvien (fluocinolone acetonide implant) and Ozurdex's rival therapies:

  • The global retinal vein occlusion market was valued at approximately $1.2 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 8-10% through 2030.
  • The diabetic macular edema segment dominates ocular inflammatory diseases, with a market size expected to surpass $2 billion by 2030, driven by rising diabetes prevalence.

Driving Factors

  • Rising Incidence of Diabetic Eye Diseases: Increasing global diabetes prevalence (estimated at 537 million adults in 2021, per IDF) fuels demand for long-acting therapies.
  • Adoption of Sustained-Release Implants: The convenience of reduces injection frequency enhances patient adherence, especially in chronic conditions.
  • Regulatory Approvals and Expanded Labeling: Approval for additional indications bolsters market penetration, especially as newer targets like uveitis gain prominence.

Market Challenges

  • Safety Concerns: Corticosteroid-related adverse effects, notably elevated IOP and cataract formation, may limit widespread adoption.
  • Pricing and Reimbursement: As biologics and small-molecule therapies enter the market, cost considerations influence clinician prescribing behavior.

Competitive Landscape

  • Iluvien offers longer-lasting (up to 36 months) corticosteroid therapy but has faced slow adoption due to safety concerns.
  • Anti-VEGF Agents like Eylea, Lucentis, and Beovu dominate market share owing to their superior safety profile, prompting combination strategies.
  • Emerging Biologic and Biosimilar Therapies threaten to reshape osteoporosis and ocular inflammation markets, pressuring OZURDEX's share.

Market Projections

Future Trends and Forecasts

  • The retinal vein occlusion and DME markets are expected to grow steadily, benefiting OZURDEX’s deployment, especially with ongoing trials targeting extended dosing intervals.
  • As biosimilar and alternative therapies mature, OZURDEX's niche will shift towards patients unresponsive to or intolerant of anti-VEGF therapies.

Forecasted Sales Volume

  • Industry estimates project OZURDEX's global sales to reach $300–$400 million annually by 2025, a moderate growth reflecting increased indication approvals, improved formulations, and integration into combination regimens.

Strategic Opportunities

  • Targeting emerging markets with growing diabetic populations.
  • Developing personalized medicine approaches, selecting patients based on predictive markers for corticosteroid responsiveness.
  • Collaborating on combination regimens with anti-VEGF therapies to expand indications and improve outcomes.

Key Challenges and Risks

  • Safety Profile Management: Balancing efficacy with corticosteroid-associated risks remains central to market acceptance.
  • Pricing Strategies: Navigating reimbursement landscapes and establishing cost-effectiveness compared to competing therapies.
  • Regulatory Hurdles: Expanding indications require rigorous evidence and approvals, potentially prolonging market entry or expansion timelines.

Key Takeaways

  • Clinical developments focus on extending OZURDEX’s dosing intervals, enhancing safety profiles, and exploring combination therapies, solidifying its therapeutic role.
  • The market environment is robust, driven by rising prevalence of diabetic retinal diseases and patient preference for sustained-release options.
  • Future growth hinges on innovating formulations, expanding indications, and effectively managing safety concerns while competing with anti-VEGF agents and emerging biologics.
  • Strategic focus should include targeting underpenetrated markets, fostering acceptance in combination treatment protocols, and optimizing patient selection to maximize benefits.

FAQs

1. What are the primary indications for OZURDEX?
OZURDEX is approved for treating macular edema following retinal vein occlusion, diabetic macular edema, and non-infectious uveitis affecting the posterior segment of the eye.

2. How does OZURDEX compare to anti-VEGF therapies?
While anti-VEGF agents are first-line for many indications due to a favorable safety profile, OZURDEX offers a longer-lasting corticosteroid option, particularly useful in refractory cases or when anti-VEGF therapy is contraindicated or insufficient.

3. What safety concerns are associated with OZURDEX?
The primary risks include increased intraocular pressure and cataract progression. Proper patient selection and monitoring are essential.

4. Are there ongoing efforts to extend the duration of OZURDEX's efficacy?
Yes, current clinical trials are assessing extended-release formulations and dosing intervals, aiming for 6- to 12-month efficacy with a single implant.

5. What is the outlook for OZURDEX in the next five years?
With ongoing clinical trials, expanded indications, and market growth in chronic ocular diseases, OZURDEX is positioned for moderate growth, particularly with integration into combination treatments and in markets with rising diabetic populations.


References

[1] Allergan (AbbVie), "OZURDEX Prescribing Information," 2022.
[2] International Diabetes Federation, "IDF Diabetes Atlas," 2021.
[3] Market Research Future, "Retinal Vein Occlusion Market Analysis," 2022.
[4] BrightFocus Foundation, "Corticosteroid Implants in Ophthalmology," 2023.
[5] U.S. Food and Drug Administration, "OZURDEX FDA Approval Details," 2014.

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