Jetrea - Ocriplasmin

What is Jetrea Jetrea - Ocriplasmin and what is it used for?

Jetrea is a medicine that contains the active substance ocriplasmin. It is indicated in adults for the treatment of vitreomacular traction (VMT), an eye disease that can cause severe visual disturbances.

How is Jetrea - Ocriplasmin used?

Jetrea is a concentrate that is made up into a solution for ocular injection. The medicine can only be obtained with a prescription and must be prepared and administered by an ophthalmologist (specialist in eye diseases), with experience in intravitreal injections (injections in the vitreous body, the gelatinous mass located in the back of the eye) . The concentrate must be stored in a freezer and the procedure must take place under sterile conditions.

The recommended dose is 0.125 mg, administered by injection into the affected eye only once as a single dose. The other eye should not be treated with Jetrea for at least 7 days.

The ophthalmologist can prescribe antibiotic eye drops before and after treatment with Jetrea, in order to prevent eye infections. Patients should be monitored after injection to rule out any infection or increased intraocular pressure.

How does Jetrea - Ocriplasmin work?

Vitreomacular traction is caused by vitreomacular adhesion (VMA), whereby the vitreous body remains attached with abnormal force to the central part of the retina (the inner most sensitive membrane of the eye). Over the years, the size of the vitreous body is reduced and the area affected by the abnormal attachment can exert traction on the retina, which in turn causes swelling of the retina itself and symptoms such as blurred or distorted vision.

The active ingredient of Jetrea, ocriplasmin, is similar to human plasmin, an enzyme naturally present in the eye that can break down the proteins responsible for adhesion between the vitreous body and retina, thereby reducing swelling and improving eyesight.

The ocriplasmin present in Jetrea is produced by a method known as "recombinant DNA technology": that is, it is obtained from yeast cells into which a gene (DNA) has been introduced that allows them to produce ocriplasmin.

What benefit has Jetrea - Ocriplasmin shown during the studies?

During the studies, Jetrea has been shown to effectively resolve the adhesion between vitreous body and retina, reducing the need to resort to surgery.

In two main studies involving 652 adults with VMA and vision loss, patients were given a single dose of 0.125 mg Jetrea or placebo (a dummy treatment) by intravitreal injection.

After 28 days, adhesions were cured in 25% and 28% of patients treated with a Jetrea injection (61 out of 219 and 62 out of 245) compared to 13% and 6% of subjects treated with placebo (14 out of 107 and 5 out of 81). Effective treatment of VMA can help resolve vision disorders caused by VMT and prevent further visual impairment associated with progressive and untreated retinal traction.

What are the risks associated with Jetrea - Ocriplasmin?

The side effects observed with Jetrea affect the eye. The most common side effects of Jetrea are flying flies (dark spots and often irregularly shaped in the visual field), eye pain and photopsia (light sensation in the form of flashes in the visual field) as well as conjunctival hemorrhage (bleeding from the membrane covering the eyeball ). For the full list of all side effects reported with Jetrea, see the package leaflet.

Jetrea should not be used in patients with an established or suspected infection in the eye or around the eye. For the full list of limitations, see the package leaflet.

Why has Jetrea - Ocriplasmin been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Jetrea's benefits are greater than its risks and recommended that it be approved for use in the EU. Studies have shown that Jetrea has been effective in the treatment of vitreomacular adhesion and, therefore, the medicine is expected to be effective in preventing episodes of impaired vision, which can occur in the presence of untreated and progressive vitreomacular traction. Although modest (resolution of VMA in a quarter of patients), the benefits of the medicine have been considered significant since treatment with Jetrea can improve vision and avoid surgery. As for the safety of the medicine, the most common side effects, which have been short-lived and are considered manageable, are often secondary to the injection procedure or related to the resolution of the disease itself. The risk of more serious undesirable effects, such as an irreversible decrease in vision, other alterations in the function of the retina or crystalline support structures, appears reduced.

What measures are being taken to ensure the safe and effective use of Jetrea - Ocriplasmin?

A risk management plan has been developed to ensure that Jetrea is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Jetrea, including the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company that produces Jetrea must ensure that all health professionals who could use Jetrea receive an information package containing fundamental information on how to use the medicine as well as an information package to be transmitted to patients.