Ocriplasmin

Recombinant truncated form of human plasmin (a serine protease); a vitreolytic agent.1 2 3 6 7 9 10 12 13

Vitreomacular Adhesion

Treatment of symptomatic vitreomacular adhesion (VMA).1 2 14

Provides pharmacologic (nonsurgical) option for patients with less severe symptomatic VMA to receive treatment at an earlier stage and potentially avoid surgical complications.2 3 9 10 11 14 5

Administration

Ophthalmic Administration

Administer by intravitreal injection only into the affected eye by a qualified physician.1

Must be diluted prior to intravitreal administration.1 Remove vial from freezer and allow contents to thaw at room temperature for several minutes.1 Once completely thawed, dilute with 0.2 mL of sterile, preservative-free 0.9% sodium chloride for injection.1 Gently swirl to mix contents.1

Prior to intravitreal administration, withdraw entire contents of vial (0.4 mL) through a sterile 19-gauge needle into a 1-mL syringe (both provided by manufacturer4 ) using aseptic technique.1 Discard needle and replace with sterile 30-gauge needle (also provided by manufacturer4 ) for intravitreal injection.1 To obtain appropriate dose (0.125 mg), carefully expel air bubbles and excess drug until plunger tip is aligned with the line that marks 0.1 mL on the syringe.1 Use immediately because drug product contains no preservatives.1

Inject under controlled aseptic conditions (including use of sterile gloves, sterile drape, and sterile eyelid speculum [or equivalent]) following adequate anesthesia and administration of a broad-spectrum anti-infective agent.1

To administer intravitreally, insert 30-gauge injection needle 3.5–4 mm posterior to the limbus, aiming toward the center of vitreous cavity in order to deliver intended dose to the mid-vitreous.1 Avoid injecting into the horizontal meridian.1

Monitor patients for elevation of IOP immediately following intravitreal injection; monitoring may include evaluation of optic nerve head perfusion or tonometry.1 A sterile paracentesis needle should be available.1

Use each vial only for treatment of a single eye; discard any unused portion.1 If contralateral eye requires treatment, use a new vial; change sterile field, syringe, gloves, drape, eyelid speculum, and injection needle before administering into the other eye.1 (See Dosage under Dosage and Administration.)

Repeated administration in the same eye is not recommended.1

Dosage

Adults

Intravitreal injection: 0.125 mg (0.1 mL of diluted solution) into the affected eye once as a single dose.1 Repeated doses not recommended because of possible increased risk of lens subluxation.1 14 (See Lens Subluxation under Cautions.)

If contralateral eye requires treatment, wait >7 days after initial injection before administering to contralateral eye because monitoring of postinjection course (including potential for decreased vision) in injected eye is necessary.1

Special Populations

Dosage modification not required based on age or gender.1

• Risk of intraocular inflammation or infection.1 Importance of patients informing their ophthalmologist immediately if change in vision occurs or if the treated eye becomes red, sensitive to light, or painful.1

• Possible risk of temporary visual impairment after intravitreal injection;1 importance of avoiding driving a vehicle or operating heavy machinery until visual impairment has resolved.1 If visual impairment persists or worsens, importance of seeking care from an ophthalmologist.1

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1

• Importance of informing patients of other precautionary information.1 (See Cautions.)

• It is used to treat vitreomacular adhesion (VMA).

• If you have an allergy to ocriplasmin or any other part of ocriplasmin.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Applies to ocriplasmin ophthalmic: intraocular solution

Along with its needed effects, ocriplasmin ophthalmic may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking ocriplasmin ophthalmic:

• Bloody eyes
• blurred vision or other change in vision
• decreased vision
• eye pain
• redness of the eye
• seeing flashes or sparks of light
• sensitivity of the eye to light
• tearing

• Change in color vision
• difficulty seeing at night
• eye discomfort
• loss of vision
• seeing floating spots before the eyes, or a veil or curtain appearing across part of vision
• throbbing pain

Some side effects of ocriplasmin ophthalmic may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Dry eyes