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. DrugPatentWatch analysis and 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 DrugPatentWatch Analysis and 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	DrugPatentWatch analysis and company disclosures
Thrombogenics Inc.	JETREA	ocriplasmin	Injection	125422		2023-12-05	DrugPatentWatch analysis and company disclosures
Thrombogenics Inc.	JETREA	ocriplasmin	Injection	125422		2027-04-11	DrugPatentWatch analysis and 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

International Patents for ocriplasmin

Country	Patent Number	Estimated Expiration
Australia	2003300821
Austria	E534400
European Patent Office	2327416

Supplementary Protection Certificates for ocriplasmin

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
47/2013	Austria		PRODUCT NAME: OCRIPLASMIN; REGISTRATION NO/DATE: EU/1/13/819/001 (MITTEILUNG) 20130315
2013/042	Ireland		PRODUCT NAME: MICROPLASMIN; REGISTRATION NO/DATE: EU/1/13/819/001 20130315
C01232252/01	Switzerland		PRODUCT NAME: OCRIPLASMINUM; REGISTRATION NO/DATE: SWISSMEDIC 63053 13.03.2014

Market Dynamics and Financial Trajectory for the Biologic Drug: Ocriplasmin

Last updated: July 28, 2025

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Introduction

Ocriplasmin, marketed under the brand name Jetrea, is a recombinant protease approved for the treatment of symptomatic vitreomacular adhesion (VMA) and vitreomacular traction (VMT). As a biologic agent aimed at addressing specific retinal disorders, its market trajectory reflects both clinical evolution and evolving healthcare economics. This analysis explores the key drivers shaping Ocriplasmin's market dynamics and forecasts its financial trajectory amid competitive, regulatory, and technological shifts.

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Overview of Ocriplasmin’s Pharmacology and Clinical Positioning

Ocriplasmin is a recombinant enzyme that enzymatically cleaves proteins within the vitreoretinal interface, promoting the separation of the posterior hyaloid from the retina. Its minimally invasive, pharmacologic approach offers an alternative to vitrectomy surgery, which historically has been the standard of care for VMA and VMT.

Clinically, Ocriplasmin demonstrated efficacy in resolving VMA and improving vision in selected patient populations, notably in those without epiretinal membrane (ERM). The pivotal MVI-600-101 trial established its utility, leading to FDA approval in 2012 (1). The drug’s non-surgical profile initially positioned it as a disruptive innovation in ophthalmology, but subsequent real-world data revealed variable response rates, impacting market penetration.

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Market Drivers

1. Clinical Efficacy and Patient Selection

The success of Ocriplasmin hinges on precise patient selection. Its efficacy is highest in patients aged under 65 with focal VMA and no ERM, reducing the potential market size. Variability in response rates—approximately 40-50% in clinical trials—limits widespread adoption and necessitates concomitant or alternative interventions (2).

2. Competition from Surgical and Conservative Treatments

Vitrectomy remains a definitive treatment for VMA/VMT, offering higher resolution rates but at the cost of invasiveness, risks, and longer recovery times. Pharmacologic alternatives are attractive but limited by variable efficacy and recalcitrant cases with ERM or other complicating factors. The emergence of other pharmacologic agents, such as ocriplasmin biosimilars or proprietary enzymes, could threaten market share.

3. Regulatory and Reimbursement Landscape

Regulatory authorities have maintained Ocriplasmin’s approval, but reimbursement policies influence uptake. In markets with restrictive coverage or high out-of-pocket costs, patient access and clinician preference may shift towards surgical options or emerging therapies. The pricing strategy and payer negotiations critically impact revenue generation.

4. Technological and Diagnostic Advances

Integrating advanced imaging technologies like OCT (Optical Coherence Tomography) enhances patient selection, potentially improving response rates and market penetration. Better diagnostics can enhance clinician confidence in prescribing Ocriplasmin and target suitable patients.

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Market Dynamics

1. Market Penetration and Adoption Trends

Following its approval, Ocriplasmin experienced initial rapid adoption driven by ophthalmologists seeking non-surgical options. Yet, subsequent data has tempered enthusiasm, especially in complex cases or those with ERM, leading to plateauing sales. The narrow indication spectrum constrains market expansion.

2. Evolving Clinical Guidelines

Updated ophthalmic guidelines increasingly recommend vitrectomy as the primary intervention in complex cases. Pharmacologic therapy remains reserved for specific subsets, cementing its niche market. Ongoing education and real-world evidence are vital for broader acceptance.

3. Geographic Variability

Market size dynamics differ internationally. In the U.S., regulatory clarity and reimbursement facilitate adoption, whereas in emerging markets, limited access and infrastructural constraints challenge uptake. Europe and Asia-Pacific also exhibit divergent trajectories influenced by healthcare systems and population demographics.

4. Patent and Commercial Strategies

Patent expirations and biosimilar developments could alter competitive landscapes over the next decade. Companies pursuing licensing or advanced formulations might influence market share and pricing structures.

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Financial Trajectory Forecast

1. Revenue Projections

Analysts project a gradual plateau in revenue growth, with estimates ranging from $50 million to $100 million annually globally over the next five years (3). The initial rapid growth phase, fueled by novel therapeutic positioning, is tempered by market saturation and clinical limitations.

2. Market Share Dynamics

Given its niche indication, Ocriplasmin's market share is expected to stabilize in low to mid-single digits of the overall retinal therapeutic market, which itself is projected to grow at approximately 4-6% annually due to aging populations and increasing AMD and diabetic retinopathy prevalence.

3. Cost Structure and Profitability

Manufacturing biologics like Ocriplasmin entails high R&D and production costs. The relatively limited size of the targeted patient cohort challenges profitability, especially if reimbursement policies tighten or if biosimilars emerge. However, optimized supply chains and expanded indications could enhance margins.

4. Impact of Emerging Therapies

Future innovations, such as gene therapy or novel pharmacologic agents with higher efficacy, could reduce Ocriplasmin’s market share. Conversely, its role may expand if formulations improve, reducing adverse effects or enhancing response rates.

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Strategic Implications and Industry Outlook

The long-term sustainability of Ocriplasmin hinges on strategic positioning. Pharmaceutical companies must leverage advanced diagnostics to identify suitable candidates, educate clinicians, and adapt pricing models to optimize access. Simultaneously, investment in pipeline advancements or combination therapies could fortify the product’s market relevance.

Furthermore, evolving regulatory policies favoring minimally invasive treatments can catalyze future opportunities, provided clinical efficacy improvements keep pace with competing innovations.

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Key Takeaways

• Limited but Stable Market: Ocriplasmin’s niche role in managing VMA/VMT is constrained by patient selection criteria and variable efficacy, leading to a stable but modest revenue trajectory.
• Competitive Landscape: Ongoing advances in surgical techniques and emerging pharmacologic options influence its adoption, with vitrectomy remaining dominant in complex cases.
• Reimbursement and Healthcare Policies: Payer policies significantly impact market penetration; optimizing clinical value and cost-effectiveness remains critical.
• Innovation and Diagnostics: Precision medicine approaches, including OCT-based patient selection, will bolster efficacy and expand its utilization.
• Future Outlook: A gradual plateau is anticipated, with growth dependent on biosimilar competition, pipeline innovations, and enhanced clinical strategies.

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FAQs

1. What are the main factors limiting Ocriplasmin’s market growth?
Limited efficacy in complex cases with epiretinal membranes, restrictive patient selection criteria, competition from surgical procedures, and payer reimbursement challenges inhibit broader adoption.

2. How does Ocriplasmin compare to vitrectomy in clinical outcomes?
While Ocriplasmin offers a minimally invasive option with approximately 40-50% success in selected patients, vitrectomy achieves higher anatomical resolution rates but involves surgical risks and longer recovery.

3. Are biosimilars or generic versions of Ocriplasmin expected to impact the market?
Potential biosimilar entries could reduce pricing and expand access, particularly in cost-sensitive markets, but depend on regulatory approval, patent landscape, and manufacturing complexities.

4. Which markets are most promising for Ocriplasmin?
The United States remains the primary market due to advanced healthcare infrastructure, while Europe and Asia-Pacific present significant growth potential with expanding ophthalmic indications and increasing disease prevalence.

5. What future innovations could influence the outlook of Ocriplasmin?
Advancements in gene therapy, combination pharmacologics, and improved imaging diagnostics could refine patient selection, enhance efficacy, and potentially extend indications, impacting its market trajectory.

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References

1. Stalmans P, et al. "Enzymatic vitreolysis with ocriplasmin for symptomatic vitreomacular adhesion." Lancet, 2012.
2. Schubert C, et al. "Real-world effectiveness of ocriplasmin for vitreomacular traction and macular holes." Retina, 2018.
3. market research reports, 2022-2023.

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