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FDA approves ocriplasmin for treatment of symptomatic vitreomacular adhesion
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The U.S. Food and Drug Administration has approved ocriplasmin to treat symptomatic vitreomacular adhesion, according to a news release from ThromboGenics.
The approval follows a phase 3 program in which Jetrea (ocriplasmin) was superior to placebo for the treatment of symptomatic vitreomacular adhesion. In two trials, 26.5% of patients who received ocriplasmin had resolution of vitreomacular adhesion compared with 10.1% of patients who received placebo (P < .01). Most adverse events with ocriplasmin were mild and transient, according to the release.
The recommended dose of ocriplasmin is 0.125 mg (0.1 mL) of the diluted solution delivered to the affected eye by intravitreal injection.
The agent is a selective proteolytic enzyme that cleaves fibronectin, laminin and collagen, three important parts of the vitreoretinal interface that are involved with vitreomacular adhesion, the release said.
ThromboGenics intends to launch Jetrea in the United States in January, CEO Patrik De Haes, MD, said in the release.
“The FDA approval is undoubtedly a major milestone for ThromboGenics,” De Haes said in a follow-up press conference.