Last Updated: May 14, 2026

CLINICAL TRIALS PROFILE FOR OCRIPLASMIN


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All Clinical Trials for ocriplasmin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00412451 ↗ A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin Versus Sham Injection for Treatment of Patients With Diabetic Macular Edema (DME) Completed ThromboGenics Phase 2 2006-12-01 A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with DME.
NCT00435539 ↗ A Study to Compare Multiple Doses Intravitreal Microplasmin for Treatment of Patients With Vitreomacular Traction (MIVI-IIt) Completed ThromboGenics Phase 2 2007-02-01 A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with vitreomacular traction.
NCT00913744 ↗ Safety and Efficacy Study of Intravitreal Ocriplasmin in Subjects With AMD With Focal Vitreomacular Adhesion Completed ThromboGenics Phase 2 2010-01-01 This study will evaluate the safety and efficacy of Ocriplasmin intravitreal injection, in subjects diagnosed with exudative AMD with focal vitreomacular adhesion. Ultimately, it is believed that intravitreal ocriplasmin may offer physicians a safe agent for pharmacologic vitreolysis and nonsurgical resolution of focal vitreomacular adhesion in AMD subjects where this adhesion may be causally associated with worse prognosis).
NCT00986362 ↗ Clinical Trial of Intravitreal Microplasmin in Infants and Children Scheduled for Vitrectomy Completed ThromboGenics Phase 2 2010-02-01 To evaluate the safety and preliminary efficacy of intravitreal microplasmin as an adjunct to conventional vitrectomy for the treatment of pediatric patients.
NCT01159665 ↗ The Purpose of This Study is to Evaluate the Pharmacokinetic Properties of Intravitreal Ocriplasmin Prior to Planned Primary Pars Plana Vitrectomy (PPV) Completed ThromboGenics Phase 2 2010-07-01 To evaluate the pharmacokinetic properties of intravitreal ocriplasmin 125 µg dose when administered at different time-points prior to planned primary pars plana vitrectomy (PPV)
NCT01287988 ↗ Follow-up Study to Assess Visual Function in Subset of Patients Who Have Previously Participated in the TG-MV-006 and TG-MV-007 Ocriplasmin Studies Completed ThromboGenics 2011-05-01 The primary objective of this study is to assess visual function in up to 44 patients who have previously participated in either of the placebo controlled, ocriplasmin Phase III studies (TG-MV-006 or TG-MV-007).
NCT01429441 ↗ Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole Completed ThromboGenics Phase 3 2011-10-01 The purpose of this study is to evaluate the treatment of symptomatic vitreomacular adhesion / (VMT) including macular hole with ocriplasmin.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ocriplasmin

Condition Name

Condition Name for ocriplasmin
Intervention Trials
Vitreomacular Traction 4
Symptomatic Vitreomacular Adhesion 2
Vitrectomy 2
Vitreomacular Adhesion 2
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Condition MeSH

Condition MeSH for ocriplasmin
Intervention Trials
Tissue Adhesions 6
Vitreous Detachment 3
Edema 1
Retinal Perforations 1
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Clinical Trial Locations for ocriplasmin

Trials by Country

Trials by Country for ocriplasmin
Location Trials
United States 35
Belgium 6
Germany 6
United Kingdom 5
Italy 3
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Trials by US State

Trials by US State for ocriplasmin
Location Trials
Texas 5
California 3
Michigan 3
Florida 3
Virginia 2
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Clinical Trial Progress for ocriplasmin

Clinical Trial Phase

Clinical Trial Phase for ocriplasmin
Clinical Trial Phase Trials
Phase 4 2
Phase 3 2
Phase 2 7
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Clinical Trial Status

Clinical Trial Status for ocriplasmin
Clinical Trial Phase Trials
Completed 11
Terminated 2
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Clinical Trial Sponsors for ocriplasmin

Sponsor Name

Sponsor Name for ocriplasmin
Sponsor Trials
ThromboGenics 9
Alcon Research 3
Katholieke Universiteit Leuven 1
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Sponsor Type

Sponsor Type for ocriplasmin
Sponsor Trials
Industry 12
Other 4
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Ocriplasmin (Jetrea) Clinical Trials Update, Market Analysis and Projection

Last updated: April 26, 2026

What is ocriplasmin and what products compete in its indication?

Ocriplasmin is a vitreolytic agent used to treat symptomatic vitreomacular adhesion (VMA) and to support treatment of vitreomacular traction (VMT) (including cases where VMT is associated with macular edema or a macular hole). The marketed product in the U.S. is Jetrea (ocriplasmin).

Competitive set (by mechanism and payer “substitute” behavior)

Ocriplasmin is not a direct molecule-for-molecule substitute; it is the only approved enzymatic vitreolytic option in this space in many markets. Clinical practice often uses:

  • Intravitreal anti-VEGF for edema-driven outcomes rather than enzymatic adhesion release (for patients with concomitant neovascular or edema components).
  • Vitrectomy as the definitive mechanical approach when traction or holes persist or when rapid anatomic resolution is needed.
Decision driver Ocriplasmin (enzymatic) Vitrectomy (surgical) Anti-VEGF (medical)
Target Vitreomacular interface separation Mechanical removal/relief Neovascularization and edema
Typical payer logic Product reimbursed for VMA/VMT indications Procedure reimbursed under surgical benefits Drug reimbursed under ophthalmology pathways
Key risk profile Procedure-related ocular events Surgical/anesthesia risks; higher utilization intensity Chronic dosing burden

What is the clinical trial landscape for ocriplasmin?

Core evidence base (late-stage and pivotal)

Ocriplasmin’s key clinical validation was built around randomized controlled trials assessing anatomic release (VMA/VMT resolution) and clinically meaningful endpoints such as visual acuity in treated populations.

Pivotal trial program (historical anchor)

  • MIVI-TRUST and MIVI-OPS (phase 3) established efficacy for VMA/VMT release and supported initial approvals. These trials demonstrated higher rates of vitreomacular separation and traction resolution with ocriplasmin versus sham. (Source: clinical trial registry records and regulatory documentation summarized in literature.)

Post-approval clinical development (current read-through)

Post-approval, the emphasis has largely shifted from new primary efficacy demonstrations in the same labeled populations to:

  • Real-world outcome characterization (treatment patterns, retreatment needs, utilization barriers such as rapid availability and patient selection).
  • Reframing of endpoints to align with routine ophthalmic practice (anatomic separation as the primary operational metric).
  • Broader adoption assessments for earlier treatment, adjunctive strategies, and observational comparisons against surgery.

The absence of a major, new phase 3 “label expansion” program dominating recent years is consistent with the mature status of the Jetrea product category. Clinical activity in the space continues, but the center of gravity remains the already-validated indication and market access rather than new pivotal efficacy claims.

What this means for pipeline-driven volatility

  • Near-term market upside for ocriplasmin is more dependent on uptake dynamics (referral and treatment conversion, guideline alignment, payer coverage stability) than on a step-function clinical re-approval or a new indication that changes the TAM substantially.

How does the labeled indication define addressable volume?

Ocriplasmin is positioned for symptomatic VMA and VMT (including VMT with macular edema or macular hole components depending on label language and jurisdictional specifics). The addressable population comes from patients diagnosed with:

  • VMA: symptomatic vitreomacular adhesion
  • VMT: vitreomacular traction, with label-consistent subgroups

In practice, the TAM depends on how quickly OCT identifies traction and how frequently ophthalmologists elect enzymatic release versus surgery.

Market analysis: What does the Jetrea opportunity look like?

Commercial reality: niche, conversion-driven market

Ocriplasmin sits in a vitreoretinal niche with:

  • Relatively low prevalence compared with broader retinal therapeutic categories.
  • High selectivity: not every VMA/VMT patient proceeds to treatment, and not every eligible patient chooses ocriplasmin versus surgery.
  • Operational constraints: enzymatic treatment requires appropriate setting, dosing workflow, and follow-up imaging.

Primary market levers

  1. Detection and referral conversion
    • Increased OCT utilization improves VMA/VMT diagnosis rates and supports earlier treatment decision-making.
  2. Treatment preference shift
    • Ophthalmologists balance traction severity, macular edema, macular hole status, and patient risk tolerance.
  3. Payer and reimbursement stability
    • Jetrea reimbursement and pharmacy benefit design influence adoption speed and clinic utilization.
  4. Availability and inventory
    • Supply consistency affects clinic ability to treat on schedule, which matters for traction cases with tighter intervention windows.

What are the pricing and access dynamics that shape revenue?

Jetrea revenue dynamics are sensitive to:

  • WAC and net price (rebates/discounts are payer and geography-dependent)
  • Dosing unit economics (single administration per episode is typical, with management of outcomes determining repeat interventions or surgery crossover)
  • Procedural substitution
    • When providers lean toward earlier vitrectomy, the enzymatic market contracts.

Without a new major label expansion, revenue growth typically comes from higher eligible conversions rather than expanded eligible populations.

Market projection: What growth path is most plausible for ocriplasmin?

Base-case framework

A reasonable projection approach for ocriplasmin uses a three-stage model:

  1. Diagnosed VMA/VMT population growth (driven by OCT adoption and screening intensity)
  2. Eligible treatment conversion (share of diagnosed patients who receive ocriplasmin)
  3. Retention and substitution (share that avoid early vitrectomy)

Given the mature label and competition from surgery for unresolved traction, the most plausible growth path is modest, driven by conversion and practice pattern inertia rather than clinical breakthrough.

Projection ranges (qualitative-to-quantitative mapping)

Because no current annual commercial revenue series is provided in the prompt, the projection below is structured as scenario bands anchored to uptake dynamics rather than to an explicit starting revenue figure.

Scenario Diagnosed volume trend Conversion to ocriplasmin Cross-over to vitrectomy Net market outcome
Conservative Flat to low growth Stable or slight decline Higher Flat-to-low single-digit CAGR
Base case Moderate growth Gradual increase in uptake Stable Low to mid single-digit CAGR
Upside Strong OCT-driven diagnosis and referral Larger uptake gains Lower cross-over Mid single-digit CAGR with occasional step-ups after guideline or coverage updates

Time horizon: 3 to 5 years is where practice patterns, payer behavior, and clinic operational readiness change enough to show sustained revenue effects without waiting for new phase 3 readouts.

Clinical adoption: where does ocriplasmin win in practice?

Ocriplasmin wins when clinicians prioritize:

  • Rapid enzymatic release of vitreomacular traction without surgery
  • Patient preference to avoid invasive procedures
  • Cases where anatomic resolution probability is high and vitrectomy risk is judged unfavorable

It loses when:

  • Traction is severe or complicated by macular pathology that makes surgery the more reliable anatomic endpoint
  • Patients present late in the traction timeline and are more likely to require surgical management

What endpoints matter for payer and hospital formulary decisions?

Formulary value is tied to:

  • Anatomic separation / traction resolution rate
  • Time-to-resolution
  • Requirement for rescue interventions
  • Safety profile in real-world use
  • Follow-up imaging burden and downstream utilization

Ocriplasmin’s product value proposition is typically expressed through outcomes that can be observed on OCT after treatment rather than long-term systemic outcomes.

Key Takeaways

  • Ocriplasmin is a mature, niche vitreolytic therapy for symptomatic VMA/VMT; near-term performance is driven more by adoption and substitution dynamics than by new pivotal clinical expansions.
  • The competitive set is dominated by vitrectomy for definitive traction management, with anti-VEGF used for edema-related components rather than traction resolution.
  • Market growth is most likely to remain modest (low to mid single-digit CAGR in a base case) and depends on OCT-driven diagnosis rates and the share of eligible patients converting to enzymatic treatment.

FAQs

1) Is ocriplasmin a first-line alternative to vitrectomy?

It is used as an alternative to surgery in labeled VMA/VMT populations where anatomic resolution potential supports enzymatic release and where clinicians judge surgery risk higher than enzymatic intervention.

2) What is the main measurable outcome after ocriplasmin?

OCT-based anatomic release of the vitreomacular interface, reflected in traction resolution and/or separation rates used in pivotal and label-linked endpoints.

3) Does anti-VEGF compete directly with ocriplasmin?

Not directly. Anti-VEGF addresses edema and other retinal vascular drivers; ocriplasmin targets the vitreomacular interface mechanism.

4) What factors most influence ocriplasmin uptake?

Referral conversion, OCT diagnostic practices, clinician selection for enzyme treatment versus surgery, and reimbursement coverage design.

5) What could shift ocriplasmin market growth upward?

Improved diagnosis-to-treatment conversion and reduced cross-over to vitrectomy through better patient selection and consistent clinic execution.


References (APA)

[1] U.S. National Library of Medicine. (n.d.). ClinicalTrials.gov: Studies of ocriplasmin in vitreomacular adhesion/traction. https://clinicaltrials.gov/
[2] Food and Drug Administration. (n.d.). Jetrea (ocriplasmin) prescribing information and regulatory review materials. https://www.accessdata.fda.gov/
[3] European Medicines Agency. (n.d.). Jetrea (ocriplasmin) product information and assessment history. https://www.ema.europa.eu/

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