Introduction

Ocriplasmin (trade name: Jetrea) has been approved in Germany since March 2013 for the treatment of vitreomacular traction (VMT) in adults, an eye disorder that is usually age-related. The drug is also an option if the condition has caused a small hole to form in the retina.

As people age, the vitreous body of the eye (the clear gel that fills the space between the lens and the retina) shrinks and starts to detach from the retina (the lining of the back of the eye). This usually goes unnoticed, without vision being affected.

In vitreomacular traction, the retina near the point of sharpest vision (macula) remains only partly attached to the vitreous body. The retina becomes deformed as a result, which sometimes causes it to rip. This leads to blurred or distorted vision, or even loss of vision.

If visual impairment is too severe, a certain type of eye surgery (vitrectomy) is an option. This involves removing the vitreous body and repairing the retina as much as possible.

Ocriplasmin is an enzyme that can dissolve the “glue” between the vitreous body and the retina. This is done to reduce the “pulling force” on the retina – allowing it to return to a normal shape – and to avoid the need for vitrectomy.

Application

Ocriplasmin is injected once into the vitreous body of the eyeball by an ophthalmologist (eye doctor). One injection contains 0.125 mg of the drug. After the injection, patients should be monitored for one hour to check for any side effects.

If both eyes are to be treated, the second injection should be given at least seven days later.

Other treatments

For people with vitreomacular traction who have severe symptoms, surgery to remove the vitreous body (vitrectomy) is an option. Problems such as increasingly blurred vision or the changes in the retina progressing are considered to be severe symptoms.

If the symptoms are mild, such as slightly impaired vision, and if the condition doesn’t progress, regular eye check-ups are usually enough (watchful waiting).

Assessment

In 2018, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into whether ocriplasmin has any advantages or disadvantages compared with the current standard treatments for people with vitreomacular traction. The manufacturer provided five studies involving a total of 1,066 patients with mild symptoms.

Four of the five studies only lasted 6 months. In these, 592 people had treatment with ocriplasmin and 254 had injections with a placebo (fake medication). However, in order to draw any conclusions about long-term advantages or disadvantages of ocriplasmin compared with watchful waiting, longer studies are needed. Only one study monitored participants for 2 years: Here, 146 people had treatment with ocriplasmin and 74 received a placebo injection. All groups had regular check-up examinations. For people with mild symptoms, the following results were found:

What are the advantages of ocriplasmin?

  • Improvement of visual acuity (sharpness of vision): After 6 months, all studies suggested that ocriplasmin has an advantage over the placebo injection here. Visual acuity improved in 36 out of 100 people who had treatment with ocriplasmin, compared to only 23 out of 100 people who were given the placebo. The longer study didn't show this advantage after 2 years, though.
  • Surgical removal of the vitreous body (vitrectomy): After 6 months, all studies suggested that ocriplasmin has an advantage here: Surgery to remove the vitreous body was carried out in 26 out of 100 people who had treatment with ocriplasmin and in 33 out of 100 people in the placebo group. But the study didn't show this advantage any more after two years.

What are the disadvantages of ocriplasmin?

  • Eye conditions: All of the studies suggest that ocriplasmin has a disadvantage here after 6 months: Eye conditions occurred in 71 out of 100 people in the ocriplasmin group and in only 53 out of 100 people in the placebo group. These eye conditions included:
    • Seeing flashes, sparks or flares: All of the studies suggest that ocriplasmin has a disadvantage in terms of this side effect: It occurred in 6 out of 100 people who had treatment with ocriplasmin, compared to only about 1 out of 100 people who had the placebo. After 2 years, the longer study still suggests that ocriplasmin has a disadvantage here compared with the placebo.
    • Changes in vision: After 6 months the studies suggested that ocriplasmin has a disadvantage here too. Changes in vision occurred in 12 out of 100 people who had treatment with ocriplasmin, compared to only 6 out of 100 people who were given the placebo.
    • Vitreous opacities: Vitreous opacities, or “floaters,” appear as black dots, specks or threads seemingly dancing in front of the eyes. 3 of the 5 studies compared ocriplasmin with a placebo injection. The data suggests that ocriplasmin also has a disadvantage in terms of this side effect when compared with the placebo injection. Even after 2 years, the longer study still suggests that ocriplasmin has a disadvantage compared with the placebo.
  • Dyschromatopsia (defective color vision): The 2-year study suggests that ocriplasmin has a disadvantage regarding this side effect as well. About 40 out of 100 people who had treatment with ocriplasmin had dyschromatopsia, compared to only 20 out of 100 people who were given the placebo.
  • Sensitivity to light: Here too, the same study suggests that ocriplasmin has a disadvantage after 2 years: This side effect only occurred in the ocriplasmin group – in 13 out of 100 people.

No differences

  • Health-related quality of life: For the purposes of this assessment, only the study data after 6 and 12 months was suitable for analysis. No difference was found between ocriplasmin and the placebo after either of these time periods.
  • Severe side effects: No difference was found here between ocriplasmin and the placebo injections, either. In both groups, 14 out of 100 people had severe side effects. These severe side effects include a hole in the macula and retinal detachment. There was no difference here after 2 years, either.
  • Cataracts: No difference was found after either 6 months or 2 years in terms of this side effect, either.

What remains unanswered?

Blurry vision: The manufacturer didn’t provide any suitable data with which to look into this.

More information

This information summarizes the main results of reviews produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The reviews were commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the reviews and the hearings received, the G-BA passed a resolution on the added benefit of ocriplasmin (Jetrea).