Medication Monitor



Generic Name (Trade Name—Company)
Notes
October 18, 2012

Ocriplasmin

(Jetrea—ThromboGenics)
First agent approved for serious eye condition

Uses:

Treatment of symptomatic vitreomacular adhesion

FDA and ThromboGenics announced the approval of ocriplasmin for the treatment of symptomatic vitreomacular adhesion, a progressive sight-threatening condition. This is the first pharmacological agent to be approved for this indication. Ocriplasmin is a proteolytic enzyme that breaks down proteins in the eye responsible for vitreomacular adhesion.

Vitreomacular adhesion can contribute to eye problems if the vitreous starts to move away from the macula, resulting in damage of the macula because of pulling or tugging. The breakdown of proteins responsible for this condition by ocriplasmin allows for a better separation between the vitreous and macula and can reduce the chances that tugging will occur. The alternative treatment for this condition is a surgical procedure called a vitrectomy.

Approval was based on data from two Phase III clinical studies involving 652 patients with symptomatic vitreomacular adhesion. Patients were randomly assigned to receive a single injection of ocriplasmin into the eye or placebo and were evaluated over the next 28 days for efficacy and over a 6-month period for safety. Results from the trials showed that ocriplasmin was superior to placebo for achieving resolution of symptomatic vitreomacular adhesion (26.5% vs. 10.1%, P < 0.01).

Treatment with ocriplasmin was associated with mainly transient ocular adverse events. The most common adverse events reported in patients treated with ocriplasmin were eye floaters, bleeding of the conjunctiva, eye pain, photopsia, blurred vision, unclear vision, vision loss, retinal edema, and macular edema.

The recommended dose of ocriplasmin is 0.125 mg (0.1 mL) of the diluted solution administered by intravitreal injection to the affected eye once as a single injection. The injection will be available in January 2013.