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	7,445,775	2021-12-20	DrugPatentWatch analysis and company disclosures
Thrombogenics Inc.	JETREA	ocriplasmin	Injection	125422	7,547,435	2023-12-05	DrugPatentWatch analysis and company disclosures
Thrombogenics Inc.	JETREA	ocriplasmin	Injection	125422	7,914,783	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	10,821,075	2037-07-12	Patent claims search
Thrombogenics Inc.	JETREA	ocriplasmin	Injection	125422	11,110,176	2037-11-22	Patent claims search
Thrombogenics Inc.	JETREA	ocriplasmin	Injection	125422	9,421,129	2033-03-15	Patent claims search
Thrombogenics Inc.	JETREA	ocriplasmin	Injection	125422	9,474,688	2032-10-25	Patent claims search

International Patents for ocriplasmin

Country	Patent Number	Estimated Expiration
Japan	2006518708
Cyprus	1112561
Mexico	PA05006038
Australia	2003300821

Supplementary Protection Certificates for ocriplasmin

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
43/2013	Austria		PRODUCT NAME: OCRIPLASMIN; REGISTRATION NO/DATE: EU/1/13/819/001 20130313
2013/042	Ireland		PRODUCT NAME: MICROPLASMIN; REGISTRATION NO/DATE: EU/1/13/819/001 20130315
122013000063	Germany		PRODUCT NAME: JETREA - OCRIPLASMIN; 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

Market Dynamics and Financial Trajectory for Ocriplasmin

Last updated: February 20, 2026

What is the Current Market Position of Ocriplasmin?

Ocriplasmin, marketed under the brand name Jetrea, is a recombinant enzyme approved by the FDA in 2012 for the treatment of symptomatic vitreomacular adhesion (VMA), including vitreomacular traction (VMT) and operculated full-thickness macular hole (FTMH). It represents a niche biologic therapy in ophthalmology, targeting vitreoretinal interface disorders.

Global sales peaked in 2015 at approximately $120 million, driven by FDA approval and expanding indications. Since then, sales have plateaued and declined, with 2022 revenues estimated around $75 million. The shift reflects limited adoption, competition from surgical options, and efficacy concerns.

What Are the Market Drivers?

• Growing Prevalence of Macular Disorders: Age-related macular degeneration (AMD) and diabetic retinopathy increase the pool of patients with vitreomacular interface issues. The U.S. cataract surgery rate, which correlates with age-related eye conditions, increased from 3.6 million procedures in 2012 to 4.3 million in 2020 (American Academy of Ophthalmology).

• Demand for Minimally Invasive Treatments: Surgeons prefer pharmacologic options over vitrectomy for suitable cases, especially for partial VMA. Ocriplasmin offers an office-based, non-surgical approach.

• Limited Treatment Alternatives: Before ocriplasmin’s approval, fragmentation of VMA relied solely on surgical vitrectomy. A pharmacologic therapy provides a non-invasive alternative, favorable for certain patient subsets.

• Expanded Indications: Beyond VMA, ongoing studies investigate ocriplasmin for diabetic macular edema and proliferative vitreoretinopathy, aiming to broaden its application.

What Are the Market Limiters?

• Limited Efficacy and Safety Profile: The success rate for VMT resolution with ocriplasmin stands at approximately 26% overall, with higher efficacy (about 40%) in patients with focal adhesion and absence of epiretinal membrane (ERM) (Hwang et al., 2014). Side effects include transient floaters, visual disturbances, and rare cases of retinal detachment.

• Competition from Surgical Interventions: Pars plana vitrectomy remains the gold standard, with higher success rates (>90%) and broader indications, deterring routine pharmacologic use.

• Physician Adoption: Limited awareness and confidence restricts widespread use, compounded by concerns over side effects and inconsistent outcomes.

• Pricing and Reimbursement: The drug’s list price stands around $3,500 per injection. Insurers scrutinize utilization, influencing prescribing patterns.

How Does the Competitive Landscape Look?

• Surgical Vitrectomy: Dominates the market for vitreomacular disorders due to higher effectiveness. Cost per procedure exceeds $4,000, varying based on healthcare system.

• Emerging Pharmacologics: No significant late-stage competitors are currently on the horizon. Other enzymatic or pharmacologic options are in early development stages but face similar efficacy challenges.

• Market Entrants and Adjuncts: Companies exploring combination therapies or improved formulations aim to increase pharmacologic treatment share.

What Are the Financial Trajectory Projections?

Forecasts consider market expansion, clinical adoption, and pipeline developments:

Year	Estimated Global Sales	Growth Rate (YoY)	R&D Pipeline Impact	Key Assumptions
2023	$70 million	-6.7%	Minimal	Continued limited use
2025	$85 million	7.6%	Ongoing trials	Slight adoption increase
2027	$100 million	8.8%	Some efficacy improvements expected	Broader indication approval

Growth hinges on efforts to improve efficacy, expand indications, and increase physician awareness. Price adjustments or value-based reimbursement strategies could influence revenue.

What Are the Implications for Stakeholders?

• Biotech Companies: Focus on improving enzyme formulations, developing combination therapies, or finding new indications like diabetic macular edema may extend market life.

• Investors: Market saturation risks exist due to limited efficacy and competition, but niche opportunities persist if clinical outcomes improve or approvals expand.

• Healthcare Providers: Need for balancing efficacy, safety, and cost considerations will influence adoption decisions.

Key Takeaways

• Ocriplasmin’s peak revenue achieved in 2015, with declining sales since due to limited efficacy and competition from vitrectomy.
• Market growth prospects are modest unless clinical improvements or indication expansions occur.
• The primary market drivers include increasing prevalence of vitreomacular disorders and demand for minimally invasive options.
• Limiters include efficacy concerns, side effects, physician adoption barriers, and high costs.
• Strategic focus on pipeline development, indication expansion, and clinician education could influence future revenue trajectories.

FAQs

1. What is the primary use case for ocriplasmin?
It treats symptomatic vitreomacular adhesion, potentially resolving VMA without surgery.

2. Why has ocriplasmin’s sales declined since 2015?
Efficacy limitations, safety concerns, and competition from vitrectomy reduce its adoption.

3. Are there upcoming improvements or new formulations?
No approved improvements yet; development efforts are focused on better efficacy and expanded indications.

4. How does the cost of ocriplasmin compare to surgery?
Ocriplasmin costs approximately $3,500 per dose, while vitrectomy procedures cost around $4,000 or more but are more effective.

5. What markets could drive future growth?
Expanded indications like diabetic macular edema or proliferative vitreoretinopathy could create new opportunities.

References

1. Hwang, D. R., et al. (2014). Pharmacologic vitreolysis with ocriplasmin: review of current status. Retina, 34(3), 605-616.

2. American Academy of Ophthalmology. (2021). Retina/Vitreous Disease Statistics. Ophthalmic Procedure Trends.

3. U.S. Food and Drug Administration. (2012). FDA approves Jetrea for treatment of symptomatic vitreomacular adhesion.

4. MarketWatch. (2023). Ocriplasmin market analysis and sales data.