ocriplasmin intravitreal (Rx)

>10%

Conjunctival hemorrhage (17.4%)

Vitreous floaters (16.6%)

Eye pain (12.3%)

1-10%

Photopsia (9%)

Increased IOP (8.8%)

Macular hole (7.6%)

Intraocular inflammation (7.1%)

Blurred vision (6.7%)

Macular edema (4.3%)

Decreased vision acuity (5.7%)

Retinal edema (4.3%)

Photophobia (3.4%)

Intraocular hemorrhage (2.4%)

Dyschromatopsia (2%)

Vitreous detachment (1.9%)

Retinal tear (without detachment) (1.1%)

Electroretinographic changes (1%)

<1%

Lens subluxation

Retinal detachment

Postmarketing Reports

Night blindness

Contraindications

None

Cautions

Decrease of ≥3 line BCVA; these decreases in vision were due to progression of the condition and many required surgical intervention

Intravitreal injections are associated with intraocular inflammation/infection, intraocular hemorrhage and increased IOP

Potential for lens subluxation

Retinal breaks (eg, detachment, tear) reported

Dyschromatopsia (yellowish vision) and electroretinographic changes (a- and b-wave amplitude decreases) reported

Pregnancy Category: C

Lactation: Unknown whether distributed in breast milk; caution advised

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Elicits proteolytic activity against protein components within the vitreous body and vitreoretinal interface (eg, laminin, fibronectin, collagen), thereby dissolving the protein matrix responsible for vitreomacular adhesion

Absorption

0.125 mg dose corresponds to 29 mcg/mL vitreous volume

Detectable systemic levels not expected

Vitreous levels: 12 mcg/mL (within 30 min post injection); 0.5 mcg/mL (24 hr post injection)

Metabolism

Enters endogenous protein catabolism pathway and is rapidly inactivated via interactions with protease inhibitor alpha2-antiplasmin or alpha2-macroglobulin

Intravitreal Injection Preparation

Note: Solution reformulated as of February 2017; reformulated solution does NOT require further dilution

Remove vial (1.25 mg/mL corresponding to 0.375 mg ocriplasmin) from the freezer and allow to thaw to room temperature (within a few minutes)

Once completely thawed, remove the protective flip-off cap from vial and disinfect vial top with alcohol wipe

Unopened vials in the original carton protected from light can be stored up to 8 hr when stored <77°F (25°C); do not refreeze a vial once it has been thawed

Visually inspect vial for particulate matter; use only if clear, colorless solution without visible particles

Withdraw all diluted solution using 19-gauge needle and discard needle after vial contents withdrawn (do not use needle used to withdraw drug for intravitreal injection)

Replace need with 30-gauge needle, carefully expel air bubbles and excess drug from the syringe and adjust the dose to the 0.1 mL mark on the syringe (ie, 0.125 mg ocriplasmin)

Use solution immediately (contains no preservatives)

Discard vial and any unused portion of the diluted solution after single use

Intravitreal Administration

For single use ophthalmic intravitreal injection only

Each vial should only be used to provide a single injection for the treatment of a single eye; if contralateral eye requires treatment, a new vial should be used and the sterile filed, syringe, gloves, drapes, eyelid speculum, injection needles should be changed

Repeated injection in the same eye not recommended Procedure should be carried out under controlled aseptic conditions, which include the use of sterile gloves, a sterile drape, and a sterile eyelid speculum

Adequate anesthesia and a broad spectrum microbiocide should be administered according to standard medical practice

The injection needle should be inserted 3.5-4 mm posterior to the limbus aiming towards the center of the vitreous cavity, avoiding the horizontal meridian

The injection volume of 0.1 mL is then delivered into the mid-vitreous

Immediately following the intravitreal injection, monitor patient for elevated intraocular pressure

Appropriate monitoring may consist of a check for perfusion of the optic nerve head or tonometry; if required, a sterile paracentesis needle should be available

Storage

Store frozen at or below -4°F (-20°C)

Protect the vials from light by storing in the original package until time of use

If not used immediately after thawed, store at ≤77°F and use within 8 hr; do not refreeze