ocriplasmin

ocriplasmin

(ok-plas-min) ,

Jetrea

(trade name)

Classification

Therapeutic: ocular agents
Pharmacologic: enzymes
Pregnancy Category: C

Indications

Symptomatic treatment of vitreomacular adhesion (VMA).

Action

A proteolytic enzyme that dissolves the protein matrix present in vitreomacular adhesions.

Therapeutic effects

Dissolution of vitreomacular adhesion with improved vision.

Pharmacokinetics

Absorption: Minimal absorption
Distribution: Action is primarily local
Metabolism and Excretion: Rapidly degraded following administration
Half-life: Unknown.

Time/action profile (VMA resolution)

ROUTEONSETPEAKDURATION
Intravitrealwithin 1 wk3 wk6 mos or more

Contraindications/Precautions

Contraindicated in: None noted.
Use Cautiously in: Lactation: Effects are not know, use caution Obstetric: Use during pregnancy only if clearly needed Pediatric: Safe and effective use in children has not been established

Adverse Reactions/Side Effects

May be due to procedure

Ear, Eye, Nose, Throat

  • blurred vision (most frequent)
  • conjunctival hemorrhage (most frequent)
  • ↓ visual acuity (most frequent)
  • eye pain (most frequent)
  • macular hole (most frequent)
  • vitreous floaters (most frequent)
  • retinal edema (most frequent)
  • anterior chamber cell
  • cataract
  • conjunctival hyperemia
  • dry eye
  • dyschromatopsia (yellow vision)
  • ↑ intraocular pressure
  • intraocular inflammation/infection
  • intraocular hemorrhage
  • iritis
  • lens subluxation
  • macular edema
  • metamorphopsia (distorted vision)
  • photophobia
  • photopsia (perceived light flashes)
  • retinal degeneration
  • retinal detachment
  • vitreous detachment

Interactions

Drug-Drug interaction

None noted.

Route/Dosage

Intravitreal (Adults) 0.125 mg injected as a single dose

Availability

Solution for intravitreal injection: 0.5 mg/0.2 mL

Nursing implications

Nursing assessment

  • Monitor for elevation in intraocular pressure following injection.
  • Monitor visual acuity periodically following injection; may lead to decrease in vision.

Potential Nursing Diagnoses

Deficient knowledge, related to medication regimen (Patient/Family Teaching)

Implementation

  • Ocriplasmin must be administered by a qualified physician.
  • Intravitreal: Remove vial from freezer and allow to thaw for few min at room temperature. Add 0.2 mL of preservative free 0.9% NaCl. Swirl gently until mixed. Solution is clear and colorless without particles; do not administer solutions that are discolored or contain particulate matter. Withdraw all solution from vial with a 19 gauge needle. Replace needle with 30 gauge needle and expel excess air and solution to 0.1 mL. Discard unused solution. Administer adequate anesthesia and a broad spectrum antibiotic as per protocol. Intravitreal injection is done via aseptic technique. Repeat administration in same eye is not recommended.
    • Wait 7 days before treating other eye if necessary.

Patient/Family Teaching

  • Explain procedure for intravitreal injection to patient.
  • Advise patient to notify health care professional immediately if signs and symptoms of intraocular inflammation/infection (eye redness, sensitivity to light, eye pain, change in vision) occurs.
  • May cause visual changes. Advise patient to avoid driving and other activities requiring good vision until response to medication is known.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

  • Improved vision in patients with vitreomacular adhesions.
References in periodicals archive ?
During the EURETINA meeting, Oxurion will also be delivering further podium and poster presentations related to its other advanced clinical candidates, THR-687 and THR-317, as well as Ocriplasmin real world clinical and health economics evidence.
It also owns the global rights to JETREA (ocriplasmin), the only pharmacological vitreolysis drug approved for the treatment of symptomatic vitreomacular adhesion (in the US) and vitreomacular traction (outside the US).
Since 2012, ocriplasmin has been approved as a non-surgical, pharmacologic agent for the treatment of symptomatic VMT, but vitreolysis is only achieved in 25%-50% (8,9), with a high incidence of side effects (8) and at a high cost.
For an aperture size of less than 250 microns in IMH, intravitreal injection of ocriplasmin may prevent some patients from requiring surgical treatment [13].
ThromboGenics is conducting the CIRCLE study, a Phase II clinical trial evaluating multiple doses of THR-409 (ocriplasmin) to induce a total Posterior Vitreous Detachment in patients with Non-Proliferative Diabetic Retinopathy (NPDR).
No human eye data were found for ocriplasmin (Jetrea), an agent given as an intravitreal injection.
The company will use available Phase IIa data demonstrating the potential of Jetrea (ocriplasmin) to treat peripheral arterial occlusions.
Among the interchangeable enzymes are, for example, recombinant tissue plasminogen activator (rTPA), hyaluronidase, urokinase, plasmin, ocriplasmin, dyspase, chondroitinase ABC, and collagenase.
Travel Business Review-August 17, 2012--ALCON -Phase III Results Published in NEJM Show Ocriplasmin Could Be First Pharmacological Eye Treatment for Vitreomacular Adhesion Patients(C)2012] ENPublishing - http://www.enpublishing.co.uk
The Phase II study is designed to evaluate the safety and efficacy of up to three intravitreal injections of THR-409 (ocriplasmin) to induce complete vitreous detachment (total PVD) in NPDR patients.