A new medication, Jetrea (ocriplasmin), has been approved by the FDA for VMA (symptomatic vitreomacular adhesion), an eye condition related to aging that can lead to complications and vision loss.

When the vitreous gel adheres too strongly to the retina, it can lead to VMT (vitreomacular traction), which may in the long-run affect vision significantly. The patient may eventually develop a range of eye disorders, including macular pucker, macular hole, AMD (age-related macular generation), retinal tears, detachment, and macular edema. Symptomatic VMA is not a disease or a problem in itself, but if left untreated can lead to eye conditions that may result in vision loss, and even total blindness.

There are proteins that cause VMA. Jetrea, an enzyme, breaks these proteins down, allowing for the vitrous and macula to separate properly, thus reducing the likelihood of “tugging”.

About 500,000 people in the Western world are affected by Symptomatic VMA.

Scientists say that “Jetrea is a selective proteolytic enzyme that cleaves fibronectin, laminin and collagen, three major components of the vitreoretinal interface that play an important role in vitreomacular adhesion.”

Surgically removing the vitreous from the eye is a possible option for treating VMA; the procedure is called a vitrectomy.

Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the Center for Drug Evaluation and Research, FDA, said:

“Today’s approval represents a significant advancement in treatment for patients with symptomatic VMA. Those with this sight-threatening disease now have a non-surgical treatment option.”

FDA experts examined the data from two human trials involving 652 patients, all of them with symptomatic VMA. They were randomly selected to receive either a single Jetrea injection, or a placebo injection.

The patients were closely monitored for 28 days for evidence of side effects, and then for a further six months.

The studies showed that:

  • VMA was resolved in 26% of the Jetrea patients
  • VMA was resolved in 10% of the placebo patients

The difference between 26% and 10% is a “statistically significant” one.

The most common side effects reported by the trial participants were:

  • bleeding of the conjunctiva
  • blurred vision
  • eye floaters
  • macular edema
  • pain in the eye
  • photopsia (seeing flashes of light)
  • retinal swelling (edema)
  • unclear vision
  • vision loss

ThromoboGenics Inc., the creators and makers of Jetrea, say it is the first pharmaceutical agent to be approved for this indication.

The recommended Jetrea dose is 0.1mL (0.12rmg) of the diluted solution administered by intravitreal injected to the affected eye. The treatment involves just one injection. Jetrea is provided as a single use glass vial which contains 0.5mg in 0.2mL solution for intravitreal inject (2.5mg/mL).

CEO of ThromboGenics, Dr. Patrik De Haes, said:

“Today’s FDA approval of JETREA® is a major milestone for the Company. We are extremely pleased that we will be able to meet a major unmet clinical need in ophthalmology when we make JETREA®, the first pharmacological agent for symptomatic VMA, available to the many thousands of U.S. patients who could benefit from treatment of this progressive, sight-threatening condition.

We are continuing to prepare for the planned launch of JETREA® in January 2013 through our own U.S. commercial organization. This is the biggest step in transforming ThromboGenics into a profitable biopharmaceutical company developing and commercializing innovative ophthalmic medicines.”

Written by Christian Nordqvist