RETISERT Drug Patent Profile

When do Retisert patents expire, and when can generic versions of Retisert launch?

Retisert is a drug marketed by Bausch And Lomb and is included in one NDA.

The generic ingredient in RETISERT is fluocinolone acetonide. There are twelve drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Retisert

A generic version of RETISERT was approved as fluocinolone acetonide by FOUGERA PHARMS INC on December 16^th, 1982.

Summary for RETISERT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	9
Patent Applications:	4,804
Drug Prices:	Drug price information for RETISERT
What excipients (inactive ingredients) are in RETISERT?	RETISERT excipients list
DailyMed Link:	RETISERT at DailyMed

See drug prices for RETISERT

Recent Clinical Trials for RETISERT

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
St. Michael's Hospital, Toronto	Phase 2
Pradeepa Yoganathan	Phase 2
Unity Health Toronto	Phase 2

See all RETISERT clinical trials

Pharmacology for RETISERT

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for RETISERT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch And Lomb	RETISERT	fluocinolone acetonide	IMPLANT;INTRAVITREAL	021737-001	Apr 8, 2005		RX	Yes	Yes

Expired US Patents for RETISERT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb	RETISERT	fluocinolone acetonide	IMPLANT;INTRAVITREAL	021737-001	Apr 8, 2005	6,217,895
Bausch And Lomb	RETISERT	fluocinolone acetonide	IMPLANT;INTRAVITREAL	021737-001	Apr 8, 2005	6,548,078

International Patents for RETISERT

See the table below for patents covering RETISERT around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	0010869
Australia	2005200243
World Intellectual Property Organization (WIPO)	0056340

Supplementary Protection Certificates for RETISERT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2233112	132014902285293	Italy		PRODUCT NAME: FLUOCINOLONE ACETONIDE(ILUVIEN); AUTHORISATION NUMBER(S) AND DATE(S): 042616019, 20140530;PL27813/0001, 20120504

Market Dynamics and Financial Trajectory for RETISERT

Last updated: July 27, 2025

Introduction

RETISERT, an intravitreal implant developed for the management of chronic non-infectious posterior segment uveitis, presents a compelling case within the ophthalmic pharmaceutical landscape. Since its FDA approval in 2007, RETISERT has carved a niche in ocular pharmacotherapy, driven by the unmet need for sustained corticosteroid delivery in inflammation management. This analysis explores the current market dynamics, competitive positioning, growth drivers, challenges, and financial outlook of RETISERT, providing stakeholders with a comprehensive understanding of its trajectory.

Market Overview

Therapeutic Landscape

The global ophthalmic pharmaceutical market is projected to reach approximately USD 36 billion by 2026, expanding at a CAGR of around 4% [1]. Retinal diseases, including uveitis, diabetic retinopathy, and age-related macular degeneration, constitute a significant segment within this space. Uveitis affects an estimated 60,000 to 90,000 Americans annually, with non-infectious posterior uveitis comprising a substantial subset [2].

RETISERT occupies a specialized niche targeting these inflammatory conditions. Its mechanism involves sustained release of dexamethasone over a period of up to 36 months, positioning it as a preferred option for chronic cases requiring consistent corticosteroid levels.

Market Penetration and Adoption

Despite initial enthusiasm, RETISERT's market penetration remains limited relative to broader ophthalmic therapies. Factors influencing adoption include its invasive implantation procedure, potential for adverse events (e.g., elevated intraocular pressure, cataract formation), and competition from alternative therapies such as intravitreal corticosteroid injections, implants like Ozurdex (dexamethasone implant), and systemic immunomodulators.

Market Dynamics

Drivers

• High Unmet Medical Need: Persistent uveitis often requires prolonged corticosteroid therapy, which RETISERT offers through sustained release, reducing the frequency of intravitreal injections.
• Chronic Disease Management: The long-term delivery advantage aligns with clinical guidelines favoring sustained inflammation control, fostering clinician interest.
• Growing Awareness and Diagnosis: Advances in ophthalmic imaging and diagnostics increase detection rates of uveitis, expanding potential patient pools.

Constraints

• Invasive Delivery Method: The requirement for surgical implantation poses barriers, including procedural risks and patient discomfort.
• Adverse Events: Elevated intraocular pressure and cataract development necessitate vigilant monitoring and can impact long-term tolerability.
• Pricing and Reimbursement: High procedural and device costs affect uptake, especially in markets with limited reimbursement frameworks.

Competitive Landscape

RETISERT faces competition primarily from:

• Ozurdex (Allergan/Baxter): A biodegradable dexamethasone implant approved for various retinal diseases, including uveitis. Its less invasive administration via injection appeals to clinicians.
• Iluvien (Alimera Sciences): A fluocinolone acetonide implant, offering extended corticosteroid delivery, though with similar safety considerations.
• Systemic Immunosuppressants: Agents like methotrexate, mycophenolate mofetil, and ciclosporin provide systemic alternatives but with different safety profiles.

Emerging therapies, including biologics targeting specific inflammatory pathways, threaten to encroach upon traditional steroid-based interventions.

Financial Trajectory and Outlook

Revenue Generation and Market Share

Since its approval, RETISERT has seen modest sales, partly due to limited indications, invasive delivery, and competition. Estimated peak annual sales have historically hovered in the low hundreds of millions globally, but actual figures are constrained by its niche positioning.

Pipeline and Lifecycle Management

The prospect of expanding indications to conditions like diabetic macular edema or retinal vein occlusion remains theoretical, with no current approvals or advanced clinical trials publicly disclosed. Lifecycle management strategies, such as device enhancements or combination therapies, could influence future revenues.

Regulatory and Reimbursement Factors

Payers' acceptance hinges on demonstrating cost-effectiveness relative to alternatives. As clinical guidelines evolve and new therapies emerge, RETISERT's financial trajectory may face headwinds unless addressed through strategic value propositions.

Potential for Market Expansion

• Geographic Expansion: Emerging markets with rising ophthalmic disease burdens could offer growth opportunities, contingent on regulatory approvals.
• Clinician Education: Enhancing awareness about the safety profile and long-term benefits could improve adoption rates.

Challenges and Opportunities

Key Challenges

• High procedural morbidity concerns
• Competitive landscape favoring less invasive options
• Limited indication scope
• Reimbursement hurdles in certain healthcare systems

Opportunities

• Innovations in minimally invasive implantation techniques
• Combination therapies integrating RETISERT with other agents
• Expansion into related inflammatory or degenerative ocular conditions
• Strategic partnerships with healthcare providers and payers

Conclusion

RETISERT's market dynamics are shaped by its unique sustained-release profile, addressing a clear need in chronic uveitis management. However, its invasive administration, safety profile, and competition temper its growth trajectory. The financial outlook hinges on clinical advancements, strategic positioning, and evolving healthcare policies. Stakeholders must weigh these factors when considering investment or strategic development relating to RETISERT.

Key Takeaways

• RETISERT serves a niche role in chronic uveitis management, but faces market penetration barriers due to invasive delivery and safety concerns.
• Its competitive landscape is dominated by less invasive, similarly effective intravitreal implants and systemic therapies, constraining sales potential.
• Market growth hinges on innovations that mitigate procedural risks and demonstrate cost-effectiveness, as well as expanding indications.
• Geographic expansion to emerging markets offers potential upside amid rising prevalence of retinal inflammatory diseases.
• Strategic collaborations and pipeline enhancements are critical to improve its financial trajectory in a competitive and evolving ophthalmic landscape.

FAQs

1. What is RETISERT, and how does it differ from other corticosteroid implants?
RETISERT is a non-biodegradable, surgically implanted dexamethasone delivery device designed for sustained release over approximately three years. Unlike biodegradable injections such as Ozurdex, which are administered via outpatient procedures, RETISERT requires invasive surgery and offers longer-term therapy.

2. What are the primary safety concerns associated with RETISERT?
Key safety issues include elevated intraocular pressure, which may lead to glaucoma, and cataract progression. The implantation procedure also carries risks such as endophthalmitis and retinal detachment, impacting overall adoption.

3. How significant is the market opportunity for RETISERT?
While the global uveitis population is sizable, the drug's niche status and procedural limitations restrict its market share. Future growth depends on innovation, expanded indications, and improvements in delivery methods that facilitate broader use.

4. What are the main competitors to RETISERT, and how do they compare?
Ozurdex and Iluvien are key competitors, offering biodegradable implants administered via injection, avoiding surgical procedures. They have gained broader acceptance due to ease of use but may have shorter durations of action.

5. Will emerging biologic treatments impact RETISERT's future sales?
Yes. Biologics targeting specific inflammatory pathways may replace corticosteroid implants, especially if they offer improved safety profiles and systemic efficacy. However, corticosteroids remain preferred in certain cases, preserving some niche for RETISERT.

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Sources
[1] MarketWatch. "Ophthalmic Drugs Market Size, Share & Trends Analysis Report." 2022.
[2] Jaffe GJ, et al. "Diagnosis and treatment of uveitis." American Journal of Ophthalmology. 2021.