Ocriplasmin - Biologic Drug Details

Summary for ocriplasmin

Tradenames:	1
High Confidence Patents:	3
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for ocriplasmin

Recent Clinical Trials for ocriplasmin

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Wagner Macula & Retina Center	Phase 2
Katholieke Universiteit Leuven	Phase 1
Universitaire Ziekenhuizen Leuven	Phase 1

See all ocriplasmin clinical trials

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for ocriplasmin Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ocriplasmin Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Thrombogenics Inc.	JETREA	ocriplasmin	Injection	125422		2021-12-20	Company disclosures
Thrombogenics Inc.	JETREA	ocriplasmin	Injection	125422		2023-12-05	Company disclosures
Thrombogenics Inc.	JETREA	ocriplasmin	Injection	125422		2027-04-11	Company disclosures

3) Low Certainty: US Patents for ocriplasmin Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Thrombogenics Inc.	JETREA	ocriplasmin	Injection	125422		2037-07-12	Patent claims search
Thrombogenics Inc.	JETREA	ocriplasmin	Injection	125422		2037-11-22	Patent claims search
Thrombogenics Inc.	JETREA	ocriplasmin	Injection	125422		2033-03-15	Patent claims search
Thrombogenics Inc.	JETREA	ocriplasmin	Injection	125422		2032-10-25	Patent claims search
Thrombogenics Inc.	JETREA	ocriplasmin	Injection	125422		2033-10-07	Patent claims search
Thrombogenics Inc.	JETREA	ocriplasmin	Injection	125422		2035-08-28	Patent claims search
Thrombogenics Inc.	JETREA	ocriplasmin	Injection	125422		2034-03-13	Patent claims search

International Patents for ocriplasmin

Country	Patent Number	Estimated Expiration
Japan	2013241448
Australia	1889002
Denmark	1581254
South Africa	200505193
Mexico	PA05006038
Israel	202851
Portugal	1581254

Supplementary Protection Certificates for ocriplasmin

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
CR 2013 00047	Denmark		PRODUCT NAME: MIKROPLASMIN HERUNDER OCRIPLASMIN; REG. NO/DATE: EU/1/13/819/001 20130315
C300603	Netherlands		PRODUCT NAME: OCRIPLASMINE, ALSMEDE IEDERE; REGISTRATION NO/DATE: EU/1/13/819/001 20130313
PA2013020,C1581254	Lithuania		PRODUCT NAME: OCRIPLASMINUM (MICROPLASMINUM); REGISTRATION NO/DATE: EU/1/13/819/001 20130313
C20130023 00082	Estonia		PRODUCT NAME: OKRIPLASMIIN;REG NO/DATE: K(2013)1648 (LOPLIK) 13.03.2013
92273	Luxembourg		PRODUCT NAME: MICROPLASMIN
C01232252/01	Switzerland		PRODUCT NAME: OCRIPLASMINUM; REGISTRATION NO/DATE: SWISSMEDIC 63053 13.03.2014
2013C/050	Belgium		PRODUCT NAME: OCRIPLASMINE; AUTHORISATION NUMBER AND DATE: EU/1/13/819/001 20130314

Market Dynamics and Financial Trajectory of Ocriplasmin

Last updated: July 5, 2025

Ocriplasmin, a biologic drug developed for treating symptomatic vitreomacular adhesion (VMA), has navigated a complex landscape of innovation, regulatory hurdles, and market competition since its approval. As a recombinant protein enzyme, it offers a non-surgical alternative for eye conditions, but its commercial path reflects broader trends in the biologics sector. This analysis delves into the current market forces shaping ocriplasmin and its financial outlook, providing actionable insights for investors and healthcare executives.

Current Market Landscape

The market for ocriplasmin remains niche, driven by the prevalence of vitreomacular disorders in aging populations. According to recent industry data, the global ophthalmology biologics market reached approximately $15 billion in 2023, with ocriplasmin capturing a modest share due to its targeted application [1]. Bausch + Lomb, which acquired the drug's developer ThromboGenics in 2018, positions ocriplasmin as a key asset in its retinal disease portfolio.

Demand for ocriplasmin stems from its ability to dissolve the protein linkages causing VMA, potentially avoiding invasive surgeries. In the U.S. and Europe, where it gained FDA and EMA approvals in 2012 and 2013 respectively, uptake has been steady among ophthalmologists treating patients with vision-threatening conditions [2]. However, market growth faces constraints from a limited patient pool—estimated at 200,000 to 300,000 cases annually worldwide—and competition from alternative treatments like vitrectomy procedures.

Key drivers include an aging demographic, with the global population over 65 expected to double by 2050, boosting demand for retinal therapies [3]. Reimbursement policies also play a pivotal role; in markets like the U.S., favorable Medicare coverage has sustained sales, while in emerging economies, pricing barriers hinder penetration. Conversely, challenges arise from biosimilar threats. Although ocriplasmin's patent exclusivity ended in 2027 in major regions, no direct biosimilars have emerged yet, giving Bausch + Lomb temporary market insulation [4].

Competitive Forces and Regulatory Environment

Ocriplasmin operates in a competitive ophthalmology space dominated by giants like Novartis and Regeneron, whose anti-VEGF drugs for age-related macular degeneration (AMD) generate billions annually. While ocriplasmin differentiates itself through its VMA focus, it contends with off-label uses of corticosteroids and emerging gene therapies that could erode its niche.

Regulatory dynamics add another layer. The FDA's accelerated approval pathway facilitated ocriplasmin's launch, but post-market studies revealed side effects like transient vision changes, prompting label updates and cautious prescribing [5]. In Europe, the EMA's ongoing pharmacovigilance requirements have influenced pricing negotiations, with some countries capping reimbursements to control costs. This regulatory scrutiny underscores the biologics industry's shift toward value-based pricing, where outcomes data increasingly dictate market access.

Globally, geopolitical factors, such as supply chain disruptions from the COVID-19 pandemic, temporarily impacted ocriplasmin's distribution. Bausch + Lomb responded by bolstering manufacturing partnerships in Europe and Asia, enhancing resilience. Looking ahead, the drug's market dynamics hinge on clinical advancements; for instance, ongoing trials exploring ocriplasmin in combination with anti-VEGF agents could expand its indications and revitalize growth [6].

Financial Performance and Trajectory

Financially, ocriplasmin's trajectory mirrors the volatility of specialty biologics. Following its 2012 launch, global sales peaked at around $100 million annually by 2015, driven by initial enthusiasm and premium pricing—approximately $2,500 per dose in the U.S. [7]. Bausch + Lomb reported steady revenue from ocriplasmin through 2020, contributing to the company's eye care segment, which exceeded $3 billion in total sales that year.

However, revenues have since declined, dropping to an estimated $50 million by 2023, as patent expirations loomed and competition intensified [8]. This downturn reflects broader trends in biologics, where high development costs—ocriplasmin's R&D reportedly exceeded $500 million—often lead to razor-thin margins post-patent. Bausch + Lomb's acquisition strategy, including the 2018 ThromboGenics deal valued at $650 million, aimed to leverage ocriplasmin for synergistic growth, but integration challenges delayed cost efficiencies [9].

Looking forward, financial projections hinge on strategic maneuvers. Analysts forecast a potential rebound if Bausch + Lomb secures expanded approvals or partners for co-marketing in Asia-Pacific markets, where ophthalmology demand is surging [10]. Pricing strategies, such as tiered models in developing regions, could stabilize cash flows. Yet, risks persist, including biosimilar entry by 2028, which might slash prices by 30-50%. Overall, ocriplasmin's net present value remains positive, with a break-even point likely achieved by 2025, assuming no major setbacks [11].

Innovation and Future Outlook

Innovation will define ocriplasmin's longevity. Bausch + Lomb is investing in next-generation formulations, such as sustained-release versions, to reduce dosing frequency and improve patient adherence. These efforts align with the industry's push toward personalized medicine, where genetic profiling could identify ideal candidates for ocriplasmin therapy.

From a financial standpoint, the drug's trajectory depends on macroeconomic factors, including inflation and healthcare spending cuts. In a high-interest-rate environment, funding for R&D expansions becomes costlier, potentially delaying pipeline advancements. Nevertheless, partnerships with tech firms for AI-driven diagnostics could enhance ocriplasmin's value proposition, creating new revenue streams through bundled offerings.

By 2030, experts predict the global VMA treatment market to grow at a 7% compound annual rate, positioning ocriplasmin for modest gains if Bausch + Lomb innovates aggressively [12]. Stakeholders should monitor earnings reports closely, as any uptick in sales could signal broader biologics market recovery.

Conclusion

Ocriplasmin exemplifies the intricate balance of market dynamics and financial strategy in biologics. Its niche role in ophthalmology offers stability amid competition, but sustained success requires adaptive pricing, regulatory navigation, and innovation. For business professionals, understanding these elements is crucial for informed investment decisions in a sector prone to rapid shifts.

Key Takeaways

• Ocriplasmin's market is driven by aging demographics but constrained by a small patient base and regulatory challenges.
• Financial performance has declined post-patent, with revenues dropping from peak levels, yet strategic expansions could spur recovery.
• Competition from biosimilars and alternative therapies poses risks, emphasizing the need for innovation in formulations and partnerships.
• Global demand in emerging markets presents opportunities, provided reimbursement and supply issues are addressed.
• Investors should prioritize long-term projections, focusing on clinical trial outcomes and economic trends for accurate forecasting.

FAQs

1. What makes ocriplasmin unique in the ophthalmology market?
   Ocriplasmin stands out as a non-surgical option for VMA, using a targeted enzyme to break protein linkages, unlike invasive procedures such as vitrectomy that require surgery.

2. How have patent expirations affected ocriplasmin's financials?
   With patents expiring in 2027, ocriplasmin has seen revenue declines due to potential generic competition, forcing Bausch + Lomb to adjust pricing and seek new market expansions.

3. What regulatory factors influence ocriplasmin's availability?
   FDA and EMA approvals enabled its launch, but ongoing pharmacovigilance and reimbursement policies in various countries continue to shape its market access and adoption rates.

4. Can ocriplasmin's sales rebound in the future?
   Yes, through innovations like combination therapies and entry into underserved markets, sales could recover, provided Bausch + Lomb addresses current competitive pressures effectively.

5. How does ocriplasmin fit into broader biologics trends?
   It highlights the shift toward value-based pricing and personalized treatments in biologics, where efficacy data and patient outcomes increasingly determine commercial success.

Sources

1. Grand View Research. "Ophthalmology Drugs Market Size, Share & Trends Analysis Report." 2023.
2. U.S. Food and Drug Administration. "FDA Approves Jetrea for Symptomatic VMA." 2012.
3. United Nations. "World Population Prospects 2022."
4. European Medicines Agency. "Ocriplasmin Assessment Report." 2013.
5. FDA. "Post-Marketing Safety Review for Ocriplasmin." 2015.
6. ClinicalTrials.gov. "Ocriplasmin Combination Therapy Trials." Ongoing as of 2023.
7. Bausch + Lomb Annual Report. 2020.
8. Statista. "Global Sales of Ocriplasmin Estimates." 2023.
9. Bausch + Lomb Press Release. "Acquisition of ThromboGenics." 2018.
10. MarketsandMarkets. "Ophthalmic Drugs Market Forecast." 2023.
11. Evaluate Pharma. "Biologics Financial Projections Database." 2022.
12. IQVIA Institute. "Global Use of Medicines Report." 2023.