About ocriplasmin

Ocriplasmin, formerly known as microplasmin, is a truncated form of human plasmin. It is a small molecule designed for use in the eye that cleaves fibronectin, laminin and collagen, three major components of the vitreoretinal interface.

Under the JETREA® (ocriplasmin) brand name, ThromboGenics successfully developed ocriplasmin as the first and only pharmacological treatment indicated for symptomatic vitreomacular adhesion and vitreomacular traction. 

From thrombolytic agents to vitreo-retinal treatment

In the early 1970s, research groups in the US experimented with proteins to soften the vitreous. Exact dosage and purity proved to be the most significant obstacles. In 1979, professor Désiré Collen and his research team at the University of Leuven made a breakthrough discovery when they discovered thrombolytic agents based on tissue plasminogen activator (tPA).

In the decades that followed, ThromboGenics shifted its focus to another thrombolytic agent, ocriplasmin. Research initially focused on the treatment of a range of vascular diseases, but this scope soon expanded to include ophthalmic indications as well, eventually leading to the completion of a pivotal phase III program in 2010. Ocriplasmin was used in two trials in the US and Europe in a total of 652 patients suffering from vitreomacular adhesion (VMA).

Up till recently, the only treatment option for patients with symptomatic vitreomacular adhesion (VMA) and vitreomacular traction (VMT) was the surgical separation of the vitreous (jelly-like material in the center of the eye) from the retina (light-sensitive layer at the back of the eye) called a vitrectomy.

This is an invasive procedure which holds several risks and can lead to complications such as bleeding, pain, post-operative inflammation or irritation. Because of this, it is usually only undertaken when the patient’s vision has deteriorated significantly or they are at risk of central blindness.

Patients therefore undergo a period of ‘observation’ or ‘watchful waiting’ during which the patients’ symptoms go untreated until the symptoms become severe enough to warrant surgical treatment and repair of the retina. However, for many patients this is not a suitable option, as irreversible damage to the retina may have already occurred.

Introducing a new standard of care

JetreaThe intravitreal application of pharmacologic agents for the induction of vitreous liquefaction and/or vitreoretinal separation, an approach termed pharmacologic vitreolysis, offers a new treatment option next to watchful waiting or vitrectomy.

JETREA® is the first such drug for treating symptomatic VMA and VMT. It is administered as an injection into the eye: a unique mechanism of action. When injected into the vitreous, JETREA® dissolves the proteins that cause the vitreous to adhere to the retina. In many patients, this is enough to release the vitreous cortex from the retina and relieve the symptoms, making surgery unnecessary.

 

Ocriplasmin is currently approved and commercialized
under the brand name JETREA®

JETREA® is a welcome alternative to ‘watchful waiting’ and can be offered as an option to patients who present to the clinic with symptoms arising from VMA/VMT. Although the idea of having an injection into the eye may seem horrid, the procedure is generally painless and less invasive and disruptive to your life than surgery would be.

 

Indication

JETREA® (ocriplasmin) Intravitreal Injection, 2.5 mg/mL, is a proteolytic enzyme indicated for the treatment of symptomatic vitreomacular adhesion.

Important Safety Information
Warnings and Precautions
  • A decrease of ≥ 3 lines of best-corrected visual acuity (BCVA) was experienced by 5.6% of patients treated with JETREA and 3.2% of patients treated with vehicle in the controlled trials. The majority of these decreases in vision were due to progression of the condition with traction and many required surgical intervention. Patients should be monitored appropriately.
  • Intravitreal injections are associated with intraocular inflammation/infection, intraocular hemorrhage and increased intraocular pressure (IOP). Patients should be monitored and instructed to report any symptoms without delay. In the controlled trials, intraocular inflammation occurred in 7.1% of patients injected with JETREA vs 3.7% of patients injected with vehicle. Most of the post-injection intraocular inflammation events were mild and transient. If the contralateral eye requires treatment with JETREA, it is not recommended within 7 days of the initial injection in order to monitor the post-injection course in the injected eye.
  • Potential for lens subluxation.
  • In the controlled trials, the incidence of retinal detachment was 0.9% in the JETREA group and 1.6% in the vehicle group, while the incidence of retinal tear (without detachment) was 1.1% in the JETREA group and 2.7% in the vehicle group. Most of these events occurred during or after vitrectomy in both groups.
  • Dyschromatopsia (generally described as yellowish vision) was reported in 2% of all patients injected with JETREA. In approximately half of these dyschromatopsia cases there were also electroretinographic (ERG) changes reported (a- and b-wave amplitude decrease).
Adverse Reactions
  • The most commonly reported reactions (≥ 5%) in patients treated with JETREA were vitreous floaters, conjunctival hemorrhage, eye pain, photopsia, blurred vision, macular hole, reduced visual acuity, visual impairment, and retinal edema.