CLINICAL TRIALS PROFILE FOR OZURDEX

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.

Clinical Trial Conditions for Ozurdex

Condition Name

Condition Name for Ozurdex
Intervention	Trials
Macular Edema	30
Diabetic Macular Edema	29
Retinal Vein Occlusion	14
Diabetic Retinopathy	5

Condition MeSH

Condition MeSH for Ozurdex
Intervention	Trials
Macular Edema	64
Edema	50
Retinal Vein Occlusion	20
Neoplasms, Plasma Cell	7

Clinical Trial Locations for Ozurdex

Trials by Country

Trials by Country for Ozurdex
Location	Trials
United States	133
Australia	16
Spain	8
Canada	8
France	8

Trials by US State

Trials by US State for Ozurdex
Location	Trials
California	14
Texas	11
Florida	11
Maryland	9
Massachusetts	8

Clinical Trial Progress for Ozurdex

Clinical Trial Phase

Clinical Trial Phase for Ozurdex
Clinical Trial Phase	Trials
Phase 4	27
Phase 3	6
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for Ozurdex
Clinical Trial Phase	Trials
Completed	46
Recruiting	14
Terminated	11

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

Sponsor Type

Sponsor Type for Ozurdex
Sponsor	Trials
Other	94
Industry	62
NIH	4

OZURDEX: Clinical Trials, Market Analysis, and Projections

Introduction

OZURDEX, a dexamethasone intravitreal implant, has been a significant player in the treatment of various ocular conditions, including diabetic macular edema (DME), macular edema following branch or central retinal vein occlusion (BRVO/CRVO), and noninfectious posterior segment uveitis. Here, we delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Efficacy and Trials

Diabetic Macular Edema (DME)

The Macular Edema: Assessment of Implantable Dexamethasone in Diabetes (MEAD) trial, a phase 3, multicenter, masked, randomized, sham-controlled study, demonstrated the efficacy of OZURDEX in DME patients. The study showed that OZURDEX sustained clinically significant vision improvements throughout the 3-year trial. Approximately 22% of patients treated with OZURDEX gained 15 or more letters in best-corrected visual acuity (BCVA) from baseline at month 39, compared to 12% in the sham group[1][4].

Macular Edema Following BRVO/CRVO

Clinical studies have also shown OZURDEX to be effective in treating macular edema associated with BRVO and CRVO. The drug demonstrated a statistically significant improvement in visual acuity, with approximately 20-30% of treated patients showing an improvement of three or more lines of vision within 60 days post-implantation[4].

Noninfectious Posterior Segment Uveitis

OZURDEX has been approved for the treatment of noninfectious posterior segment uveitis, further expanding its therapeutic indications. The drug's sustained-release mechanism provides prolonged anti-inflammatory effects, which are crucial in managing this condition[1].

Adverse Events and Safety Profile

While OZURDEX has shown significant efficacy, it is not without adverse effects. Common adverse events include increased intraocular pressure, cataracts, and conjunctival hemorrhage. However, these events are generally manageable, and the intraocular pressure typically returns to baseline levels between treatment cycles[4].

Market Analysis

Market Drivers

The market for OZURDEX is driven by several factors, including the increasing prevalence and incidence of diabetes, which significantly raises the risk of diabetic macular edema. The use of off-label drugs like Avastin (bevacizumab) and the emergence of new treatments also contribute to market growth[2].

Competitive Landscape

OZURDEX competes with other treatments such as Lucentis (ranibizumab) and Avastin (bevacizumab). However, its unique sustained-release mechanism and the potential for fewer injections make it an attractive option. Cost analyses have shown that OZURDEX can reduce overall treatment costs compared to anti-VEGF treatments like bevacizumab and ranibizumab, particularly due to lower administration costs[3].

Regulatory Approvals

OZURDEX has received regulatory approvals in several regions, including the FDA approval in the United States for DME in patients with artificial lens implants or scheduled for cataract surgery. In the European Union, it was approved for DME in September 2014[4][5].

Market Projections

Diabetic Retinopathy Market

The diabetic retinopathy market, which includes treatments for DME, is expected to expand significantly. Estimates suggest that the market will reach over USD 12 billion in annual revenue by 2025, driven by the increasing prevalence of diabetes and the need for effective treatments[5].

Geographic Trends

North America is expected to remain a promising market for OZURDEX, with service providers focusing on R&D activities, mergers, and acquisitions to enhance their global presence. Regulatory approvals for novel treatments, such as the FDA approval for Eylea (aflibercept) by Regeneron Pharmaceuticals, further support market growth[5].

Outpatient Treatments

The trend towards outpatient treatments in ambulatory surgical centers (ASCs) is also expected to boost the market. Outpatient procedures offer lower costs and shorter recovery times, making them more appealing to patients, especially in price-sensitive markets[5].

Cost-Effectiveness

Studies have shown that OZURDEX can be cost-effective compared to other treatments. A cost minimization analysis indicated that OZURDEX reduces overall costs to healthcare systems, such as the NHS, by saving £4,463 per patient over 3 years compared to bevacizumab and £14,994 per patient compared to ranibizumab[3].

Key Takeaways

• Clinical Efficacy: OZURDEX has demonstrated significant vision improvements in patients with DME, BRVO/CRVO, and noninfectious posterior segment uveitis.
• Market Drivers: Increasing prevalence of diabetes and the emergence of new treatments drive market growth.
• Competitive Landscape: OZURDEX offers a unique sustained-release mechanism, reducing the need for frequent injections and potentially lowering overall treatment costs.
• Regulatory Approvals: Approved in several regions, including the FDA approval for DME in patients with artificial lens implants.
• Market Projections: The diabetic retinopathy market is expected to reach over USD 12 billion by 2025, with North America remaining a key market.
• Cost-Effectiveness: OZURDEX is cost-effective compared to other treatments like bevacizumab and ranibizumab.

FAQs

What is OZURDEX used for?

OZURDEX is used for the treatment of diabetic macular edema (DME), macular edema following branch or central retinal vein occlusion (BRVO/CRVO), and noninfectious posterior segment uveitis.

How does OZURDEX work?

OZURDEX is a sustained-release, biodegradable dexamethasone intravitreal implant that gradually releases the steroid over an extended period, suppressing inflammation.

What are the common adverse events associated with OZURDEX?

Common adverse events include increased intraocular pressure, cataracts, and conjunctival hemorrhage.

Is OZURDEX cost-effective?

Yes, studies have shown that OZURDEX can reduce overall treatment costs compared to other treatments like bevacizumab and ranibizumab.

What is the market projection for OZURDEX?

The diabetic retinopathy market, which includes treatments for DME, is expected to reach over USD 12 billion in annual revenue by 2025.

Sources

1. OZURDEX® Clinical Efficacy in DME - hcp.ozurdex.com
2. Macular Edema Market - Allied Market Research
3. NICE STA of OZURDEX® - nice.org.uk
4. Dexamethasone Ophthalmic Implant (Ozurdex) and Insert (Dextenza) - aetna.com
5. Diabetic Retinopathy Market: Top 4 trends driving the industry - biospace.com