CLINICAL TRIALS PROFILE FOR RETISERT

All Clinical Trials for RETISERT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00570479 ↗	Prophylactic Anecortave Acetate in Patients With a Retisert Implant	Completed	Alcon Research	Phase 1	2006-09-01	Retisert implant is an effective therapy for controlling inflammation in patients with non-infectious posterior uveitis. One of the major complications of this device is the development of elevated intraocular pressure (IOP) following implantation in 60% of patients. Glaucoma filtering is required in over 30% of patients at 2 years. Anecortave acetate (AA) has been shown to reduce steroid induced elevated IOP. The purpose of this study was to evaluate the ability of prophylactic anterior juxtascleral depot administration of AA to prevent this Retisert induced elevated IOP.
NCT00570479 ↗	Prophylactic Anecortave Acetate in Patients With a Retisert Implant	Completed	Texas Retina Associates	Phase 1	2006-09-01	Retisert implant is an effective therapy for controlling inflammation in patients with non-infectious posterior uveitis. One of the major complications of this device is the development of elevated intraocular pressure (IOP) following implantation in 60% of patients. Glaucoma filtering is required in over 30% of patients at 2 years. Anecortave acetate (AA) has been shown to reduce steroid induced elevated IOP. The purpose of this study was to evaluate the ability of prophylactic anterior juxtascleral depot administration of AA to prevent this Retisert induced elevated IOP.
NCT00543296 ↗	Re-implantation of a Fluocinolone Acetonide Implant for Non-infectious Uveitis Affecting the Posterior Segment	Completed	Bausch & Lomb Incorporated	Phase 4	2004-03-01	The purpose of this study is to collect data on patients with severe uveitis that have required re-implantation of the sustained-release fluocinolone drug delivery device due to depletion of study drug in their previous implanted device.
NCT00543296 ↗	Re-implantation of a Fluocinolone Acetonide Implant for Non-infectious Uveitis Affecting the Posterior Segment	Completed	Duke University	Phase 4	2004-03-01	The purpose of this study is to collect data on patients with severe uveitis that have required re-implantation of the sustained-release fluocinolone drug delivery device due to depletion of study drug in their previous implanted device.
NCT00032396 ↗	A Study to Evaluate Retisert in the Treatment of Patients With the "Wet" Form of Age-Related Macular Degeneration	Unknown status	Bausch & Lomb Incorporated	Phase 2	2001-11-01	A study evaluating Retisert in patients with age-related macular degeneration
NCT00032396 ↗	A Study to Evaluate Retisert in the Treatment of Patients With the "Wet" Form of Age-Related Macular Degeneration	Unknown status	Control Delivery Systems	Phase 2	2001-11-01	A study evaluating Retisert in patients with age-related macular degeneration
NCT00502541 ↗	Efficacy of Fluocinolone Acetonide Intravitreal Implant in Diabetic Macular Edema	Completed	Bausch & Lomb Incorporated	Phase 2/Phase 3	2001-09-01	This was a multi-center, randomized, masked, parallel-group, controlled study in patients with diabetic macular edema, comparing RetisertTM (0.59 mg) with control therapy (standard of care (SOC) - repeat macular grid laser or observation). The objective was to evaluate the safety and efficacy of the intravitreal fluocinolone acetonide implant in the treatment of patients with diabetic macular edema.

Clinical Trial Conditions for RETISERT

Condition Name

Condition Name for RETISERT
Intervention	Trials
Diabetic Macular Edema	3
Uveitis, Posterior	2
Ocular Behcet's Disease,	1
Refractory Uveitis	1

Condition MeSH

Condition MeSH for RETISERT
Intervention	Trials
Uveitis	5
Macular Edema	3
Edema	3
Uveitis, Posterior	2

Clinical Trial Locations for RETISERT

Trials by Country

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Trials by Country for RETISERT
Location	Trials
United States	5
Korea, Republic of	1
India	1
China	1

Trials by US State

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−

Trials by US State for RETISERT
Location	Trials
North Carolina	2
Maryland	1
Texas	1
Massachusetts	1

Clinical Trial Progress for RETISERT

Clinical Trial Phase

Clinical Trial Phase for RETISERT
Clinical Trial Phase	Trials
Phase 4	3
Phase 2/Phase 3	1
Phase 2	3

Clinical Trial Status

Clinical Trial Status for RETISERT
Clinical Trial Phase	Trials
Completed	6
Unknown status	2
Withdrawn	1

Clinical Trial Sponsors for RETISERT

Sponsor Name

Sponsor Name for RETISERT
Sponsor	Trials
Bausch & Lomb Incorporated	4
Texas Retina Associates	1
Kyunghee University Medical Center	1

Sponsor Type

Sponsor Type for RETISERT
Sponsor	Trials
Other	11
Industry	7

Clinical Trials, Market Analysis, and Projections for RETISERT

Introduction

RETISERT, a fluocinolone acetonide intravitreal implant, is a significant advancement in the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye. Here, we delve into the clinical trials, market analysis, and future projections for this innovative drug.

Clinical Trials and Efficacy

Trial Outcomes

RETISERT has undergone rigorous clinical trials to establish its efficacy and safety. Two randomized, double-masked, multi-center clinical studies demonstrated that RETISERT significantly reduces the recurrence rates of uveitis. In these trials, uveitis recurrence rates dropped dramatically from 53.7% to 1.8% in one trial and from 39.7% to 12.9% in another, 34 weeks post-implantation. This control was maintained over a 3-year period[1][4].

Visual Acuity and Adjunctive Therapy

The trials also showed that RETISERT stabilized or improved visual acuity in a significant number of patients. Approximately 20% to 30% of patients experienced an improvement of three lines in visual acuity between baseline and 3 years post-implantation. Additionally, the need for adjunctive therapy, including periocular injections and systemic medications, was significantly reduced[1][4].

Specific Conditions

RETISERT has been studied in various specific conditions, including sympathetic ophthalmia and cystoid macular edema (CME) resulting from immune recovery uveitis (IRU) in AIDS patients. These studies have shown that RETISERT can effectively control inflammation and reduce the dependence on systemic immunosuppression[4].

Market Analysis

Current Market Position

RETISERT is approved by the FDA for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye, a condition that affects an estimated 175,000 people in the United States. It was granted fast-track status and Orphan Drug designation by the FDA, highlighting its importance in addressing a rare and serious condition[4].

Market Size and Growth

The ophthalmic therapeutic drugs market, which includes treatments for uveitis, is growing steadily. The global market for ophthalmic therapeutic drugs is influenced by factors such as increasing prevalence of eye diseases, advancements in drug delivery technologies, and expanding prescription therapies to rural communities. While specific market size data for RETISERT alone is not readily available, the overall ophthalmic therapeutic drugs market is projected to grow, driven by the increasing need for effective treatments for various eye diseases[5].

Competitive Landscape

RETISERT is part of a broader landscape of ophthalmic treatments that include other intravitreal implants and drug delivery systems. Companies like EyePoint Pharmaceuticals, which licenses the Durasert technology to Bausch and Lomb, are actively developing and marketing similar products. The competitive landscape is characterized by a focus on sustained drug delivery technologies, which are seen as the future of retinal care[2][5].

Market Projections

Future Growth

The market for ophthalmic therapeutic drugs, including treatments like RETISERT, is expected to grow significantly. The increasing prevalence of eye diseases such as uveitis, age-related macular degeneration, and diabetic retinopathy, coupled with advancements in drug delivery technologies, will drive this growth. The global ophthalmic therapeutic drugs market is projected to continue its upward trend, with sustained drug delivery systems like RETISERT playing a crucial role[5].

Technological Advancements

Advancements in drug delivery technologies, such as the Durasert platform used by RETISERT, will continue to shape the market. These technologies offer benefits such as prolonged drug release, reduced need for frequent injections, and improved patient compliance. As these technologies evolve, they are likely to further enhance the market position of RETISERT and similar products[2].

Regulatory and Reimbursement Environment

The regulatory and reimbursement environment will also influence the market for RETISERT. With the FDA's fast-track status and Orphan Drug designation, RETISERT has already navigated significant regulatory hurdles. However, ongoing changes in global reimbursement environments may impact the drug's adoption and revenue growth. Manufacturers will need to navigate these changes to ensure continued access to this critical treatment[4][5].

Key Takeaways

• Efficacy: RETISERT has demonstrated significant efficacy in reducing uveitis recurrence rates and improving or stabilizing visual acuity.
• Market Position: It holds a unique position in the treatment of chronic noninfectious uveitis, with FDA approval and Orphan Drug designation.
• Market Growth: The ophthalmic therapeutic drugs market is projected to grow, driven by increasing prevalence of eye diseases and advancements in drug delivery technologies.
• Technological Advancements: Continued innovation in sustained drug delivery systems will enhance the market position of RETISERT and similar products.
• Regulatory Environment: Navigating regulatory and reimbursement changes will be crucial for the continued success of RETISERT.

FAQs

What is RETISERT used for?

RETISERT is used for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye.

How effective is RETISERT in reducing uveitis recurrence?

RETISERT significantly reduces uveitis recurrence rates, dropping from 53.7% to 1.8% in one trial and from 39.7% to 12.9% in another, over a 3-year period[1][4].

Does RETISERT improve visual acuity?

Yes, RETISERT has been shown to stabilize or improve visual acuity in a significant number of patients, with approximately 20% to 30% experiencing an improvement of three lines in visual acuity[1][4].

What are the potential side effects of RETISERT?

Common side effects include the development of cataracts in nearly all phakic eyes and potential increases in intraocular pressure. However, these are managed through appropriate medical care[1][4].

Is RETISERT approved by regulatory authorities?

Yes, RETISERT was approved by the FDA in April 2005 for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye[4].

What is the market outlook for RETISERT and similar ophthalmic treatments?

The market for ophthalmic therapeutic drugs, including treatments like RETISERT, is projected to grow due to increasing prevalence of eye diseases and advancements in drug delivery technologies[5].

Sources

1. Bausch and Lomb: "Long-term control is possible with Retisert" - Bausch and Lomb.
2. EyePoint Pharmaceuticals: "Investor Presentation" - EyePoint Pharmaceuticals.
3. Biospace: "Clinical Trial Management Systems Market Size to Worth USD 5.5 Billion by 2031".
4. Aetna: "Fluocinolone Acetonide Intra-vitreal Implant (Retisert, Yutiq ...)" - Aetna.
5. Fierce Pharma: "Reportlinker Adds Ophthalmic Therapeutic Drugs - Fierce Pharma".