CLINICAL TRIALS PROFILE FOR TRIESENCE

All Clinical Trials for TRIESENCE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00853905 ↗	Will the Use of Triesence During Glaucoma Surgery Provide Lower Eye Pressure and Improve the Results of the Surgery?	Completed	Alcon Research	Phase 2/Phase 3	2009-02-01	The investigators hypothesize that intracameral Triesence during glaucoma surgery will provide lower intraocular pressure through better control of ocular inflammation, thus leading to a more successful filtering procedure.
NCT00853905 ↗	Will the Use of Triesence During Glaucoma Surgery Provide Lower Eye Pressure and Improve the Results of the Surgery?	Completed	Wills Eye	Phase 2/Phase 3	2009-02-01	The investigators hypothesize that intracameral Triesence during glaucoma surgery will provide lower intraocular pressure through better control of ocular inflammation, thus leading to a more successful filtering procedure.
NCT01572350 ↗	Safety and Efficacy of Triamcinolone Acetonide Combined With Laser, Bevacizumab Combined With Laser Versus Laser Alone for the Treatment of Diffuse Non-tractional Diabetic Macular Edema	Completed	Hospital Universitario de Canarias	Phase 3	2010-10-01	This clinical trial is designed to investigate differences in terms of efficacy (mean change in best corrected visual acuity obtained after 12 months of treatment) and safety, of 3 therapeutic estrategies for non-tractional macular edema in diabetic patients: a) laser alone; b) laser plus tiramcinolon; and c) laser plus bevacizumab.
NCT01789320 ↗	Safety Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle to Treat Uveitis	Completed	Clearside Biomedical, Inc.	Phase 1/Phase 2	2013-02-01	This study is designed to determine the safety and tolerability of a single microinjection of triamcinolone acetonide (TRIESENCE®) into the suprachoroidal space (SCS) of patients who have non-infectious uveitis.
NCT02221453 ↗	Cytokine Levels in Patients With Persistent Diabetic Macular Edema Treated With Triamcinolone Acetonide	Completed	St. Michael's Hospital, Toronto	Phase 2	2015-09-01	Diabetic macular edema refers to swelling (fluid accumulation) in the center of the retina. The retina is like the film of a camera and is located in the back of the eye. This condition can develop in diabetics where swelling results from leaking of fluid from the blood vessels of the eye, into the center of the retina, the macula. If left untreated, this can affect central vision. The current standard treatment for diabetic macular edema includes medications injected directly into the eye (intravitreal injections) and laser eye treatment. The drugs that are injected directly into the eye are known as anti-Vascular Endothelial Growth Factor (anti-VEGF) agents which help to reduce the leaking. This includes bevacizumab (Avastin®) and ranibizumab (Lucentis®). However, some patients do not respond well to these anti-VEGF treatments will be given the option of switching to an another class of medications, called steroids. Triamcinolone acetonide is one of these steroids and is also injected directly into the eye. These steroids will help reduce inflammation and possibly as a consequence, reduce swelling in the eye. The purpose of this study is to determine what cellular factors affect a patient's treatment response (amount of swelling reduction) following triamcinolone acetonide intravitreal injections for diabetic macular edema.
NCT02221453 ↗	Cytokine Levels in Patients With Persistent Diabetic Macular Edema Treated With Triamcinolone Acetonide	Completed	Unity Health Toronto	Phase 2	2015-09-01	Diabetic macular edema refers to swelling (fluid accumulation) in the center of the retina. The retina is like the film of a camera and is located in the back of the eye. This condition can develop in diabetics where swelling results from leaking of fluid from the blood vessels of the eye, into the center of the retina, the macula. If left untreated, this can affect central vision. The current standard treatment for diabetic macular edema includes medications injected directly into the eye (intravitreal injections) and laser eye treatment. The drugs that are injected directly into the eye are known as anti-Vascular Endothelial Growth Factor (anti-VEGF) agents which help to reduce the leaking. This includes bevacizumab (Avastin®) and ranibizumab (Lucentis®). However, some patients do not respond well to these anti-VEGF treatments will be given the option of switching to an another class of medications, called steroids. Triamcinolone acetonide is one of these steroids and is also injected directly into the eye. These steroids will help reduce inflammation and possibly as a consequence, reduce swelling in the eye. The purpose of this study is to determine what cellular factors affect a patient's treatment response (amount of swelling reduction) following triamcinolone acetonide intravitreal injections for diabetic macular edema.
NCT02294656 ↗	Acute Pseudophakic Cystoid Macular Edema Treatment Trial: Intravitreal Ranibizumab Versus Triamcinolone Acetonide	Completed	Genentech, Inc.	Phase 1	2014-11-01	This is an open-label, Phase I/II study evaluating intravitreal ranibizumab (R) vs. intravitreal Triesence (triamcinolone acetonide) (T) in subjects with acute pseudophakic cystoid macular edema (CME). Twenty consented patients with acute CME after phacoemulsification cataract surgery with posterior chamber intraocular lens implantation (PE/PCIOL) will be randomized 1:1 to treatment with R or T. R patients will receive three monthly R injections, followed by PRN dosing. T patients will receive PRN injections every 3 months. Clinical CME is defined as clinically evident CME, with visual acuity (VA) typically in the 20/40 to 20/200 range. Re-treatment criteria will include clinically evident worsening of CME, combined with any of the following: - Any increase in spectral domain ocular coherence tomography (OCT) central macular thickness (CMT) - Any observable fluid on OCT - Any qualitatively increased perifoveal leakage/pooling on fluorescein angiography (FA). Patients will be followed monthly through 12 months.

Clinical Trial Conditions for TRIESENCE

Condition Name

Condition Name for TRIESENCE
Intervention	Trials
Uveitis	3
Diabetic Macular Edema	3
Cystoid Macular Edema	2
Glaucoma	1

Condition MeSH

Condition MeSH for TRIESENCE
Intervention	Trials
Macular Edema	6
Edema	6
Uveitis	3
Wet Macular Degeneration	2

Clinical Trial Locations for TRIESENCE

Trials by Country

Trials by Country for TRIESENCE
Location	Trials
United States	23
Canada	2
Spain	1
United Kingdom	1
Australia	1

Trials by US State

Trials by US State for TRIESENCE
Location	Trials
North Carolina	3
Pennsylvania	3
Illinois	2
Washington	1
Utah	1

Clinical Trial Progress for TRIESENCE

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for TRIESENCE
Clinical Trial Phase	Trials
Completed	6
Withdrawn	2
Recruiting	1

Clinical Trial Sponsors for TRIESENCE

Sponsor Name

Sponsor Name for TRIESENCE
Sponsor	Trials
Clearside Biomedical, Inc.	1
Oxular Limited	1
St. Michael's Hospital, Toronto	1

Sponsor Type

Sponsor Type for TRIESENCE
Sponsor	Trials
Other	9
Industry	5
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Triesence

Last updated: October 28, 2025

Introduction

Triesence (triamcinolone acetonide injectable suspension) is a corticosteroid used primarily in the treatment of ocular inflammatory conditions. Approved by the FDA in 2011, Triesence serves as an alternative to off-label use of other corticosteroids in ophthalmology, notably for macular edema and uveitis. As the demand for advanced therapies in retinal and ocular inflammatory diseases grows, understanding Triesence's clinical development, market positioning, and future outlook becomes increasingly vital for pharmaceutical and healthcare stakeholders.

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Clinical Trials Overview and Updates

Current Clinical Landscape

Triesence's clinical development has primarily involved confirming its safety and efficacy within ophthalmic indications, especially in retinal diseases such as diabetic macular edema (DME), age-related macular degeneration (AMD), and uveitis. While no recent large-scale clinical trials on Triesence itself are prominently reported, the drug's approval and use are supported by pivotal studies on corticosteroids for ocular inflammation.

Notable Clinical Evidence and Research

• Efficacy in Macular Edema: Multiple studies indicate that intravitreal triamcinolone acetonide reduces macular edema and improves visual acuity, particularly in cases resistant to anti-VEGF therapy. A landmark trial published in Ophthalmology demonstrated significant reduction in edema and visual gains, though with caution due to adverse effects like increased intraocular pressure (IOP) and cataracts [1].

• Safety and Tolerability: Post-marketing surveillance indicates Triesence is well-tolerated with manageable adverse events. Elevated IOP remains the most significant concern, necessitating regular monitoring.

Recent Clinical Trials and Innovations

• Combination Therapy Trials: Ongoing research explores combining Triesence with anti-VEGF agents to enhance treatment efficacy, particularly in refractory cases. These trials aim to determine if combination therapy can lower corticosteroid-related side effects while maintaining therapeutic benefits.

• Extended-Release Formulations: Although not directly involving Triesence, innovative sustained-release corticosteroid devices are in development, potentially reducing the frequency of injections and improving patient compliance.

Regulatory Environment

While no recent FDA approvals or extensive new clinical trials have directly involved Triesence, its off-label use and ongoing research on similar corticosteroid formulations influence its clinical standing. Marketed primarily as an off-label product, the lack of new clinical trial data is a notable gap, which may impact future development efforts.

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Market Analysis

Market Overview

The global ophthalmology drug market is projected to reach USD 25 billion by 2025, expanding at a CAGR of approximately 4-6%. Within this, corticosteroids like Triesence primarily address niche segments—retinal inflammation and edema—where their efficacy complements or substitutes anti-VEGF therapies.

Drivers

• Rising prevalence of diabetic retinopathy, AMD, and uveitis drives demand for corticosteroid options.
• Increasing use of intravitreal injections for retinal conditions boosts demand for corticosteroids like Triesence.
• Growing off-label applications and clinician familiarity bolster sales.

Limitations

• Safety Concerns: Adverse events (IOP elevation, cataract formation) limit widespread use.
• Competitive Landscape: Existence of newer corticosteroids and sustained-release implants, such as dexamethasone implants (Ozurdex), offers more sustained effects and fewer injections.
• Regulatory Challenges: Lack of recent FDA approval extensions limits marketing claims and expansion.

Competitive Positioning

Triesence distinguishes itself as a cost-effective, well-established corticosteroid for ophthalmic inflammation, with an extensive off-label footprint. However, newer formulations with longer duration and improved delivery methods pose significant competition.

Market Segmentation

• By Indication: Uveitis, diabetic macular edema, post-surgical inflammation.
• By Distribution Channel: Hospitals, ophthalmic clinics, specialized retail pharmacies.

Regional Trends

• North America: Largest market due to high prevalence of diabetic retinopathy, advanced healthcare infrastructure, and regulatory environment.
• Europe: Similar growth with regulatory acceptance extends applications.
• Asia-Pacific: Rising diabetic populations and expanding healthcare access present significant growth opportunities despite regulatory heterogeneity.

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Market Projections

Short-term Outlook (2023-2025)

• The market for corticosteroid intravitreal products is expected to grow at a CAGR of approximately 3-5%. Triesence's sales are likely to be stable, driven by existing clinician familiarity and off-label use. However, growth may be tempered by competition from sustained-release devices.
• The ongoing exploration of combination therapies may open new indications, slightly boosting market opportunities.

Long-term Outlook (2025-2030)

• Adoption of new corticosteroid delivery systems could displace traditional formulations like Triesence.
• Clinician shift toward newer, longer-acting implants and gene therapies could reduce injectable corticosteroid use.
• Nonetheless, Triesence may maintain niche relevance owing to its proven efficacy, affordability, and widespread availability, especially in areas lacking advanced infrastructure.

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Future Opportunities and Challenges

Opportunities

• Development of Extended-Release Formulations: Opportunities exist for licensing or development collaboration to enhance longevity and reduce injection frequency.
• New Indications: Expansion into inflammatory ocular diseases and postsurgical prophylaxis, pending clinical validation.
• Strategic Partnerships: Collaborations with biotech firms innovating sustained-release technologies could revitalize Triesence's market position.

Challenges

• Market Entrenchment of Newer Therapies: The growing adoption of dexamethasone implants and other sustained-release options limits Triesence’s growth.
• Safety Profile Management: Elevated IOP remains a barrier; better patient selection or combination strategies are necessary.
• Regulatory Limitations: Lack of recent approvals curtails marketing assertions and international expansion.

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Key Takeaways

• Clinical Data & Safety: Triesence’s clinical utility is well-established in managing ocular inflammation, but safety concerns necessitate careful patient monitoring.
• Market Position: It remains a cost-effective corticosteroid option, especially in resource-limited settings, but faces competition from longer-acting formulations.
• Growth Prospects: Future growth depends heavily on innovation—particularly extended-release delivery systems—and expanding indications.
• Strategic Focus: Collaborations with biotech firms and investment in lifecycle management could revitalize its market presence.
• Regulatory Engagement: Active dialogue with regulators for potential label expansions could open new revenue streams.

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FAQs

Q1: What are the key indications for Triesence?
A1: Triesence is primarily used off-label for ocular inflammatory conditions such as uveitis, macular edema, and post-surgical inflammation. Its approved label includes treatment of intraocular inflammation associated with uveitis.

Q2: How does Triesence compare with newer corticosteroid implants?
A2: Triesence is a short-acting injectable suspension requiring multiple frequent administrations, whereas newer implants like Ozurdex provide sustained drug release over several months, reducing injection frequency and possibly enhancing patient compliance.

Q3: What are the main safety concerns associated with Triesence?
A3: Elevated intraocular pressure and cataract formation are the primary safety concerns, necessitating vigilant monitoring and patient selection.

Q4: Are there ongoing clinical trials to expand Triesence’s indications?
A4: No recent large-scale trials directly involving Triesence have been announced. Most ongoing research explores combination therapies or novel formulations that could influence its future role.

Q5: What is the outlook for Triesence in emerging markets?
A5: In resource-limited regions, Triesence's affordability and established track record support steady demand, though growth may be constrained by local regulatory and healthcare infrastructure limitations.

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References

[1] Ophthalmology, “Efficacy of intravitreal triamcinolone in macular edema,” 2010.