Ocriplasmin: Long-Awaited Relief for Vitreomacular Adhesion

Brianne N. Hobbs, OD


March 06, 2013

Enzymatic Vitreolysis With Ocriplasmin for Vitreomacular Traction and Macular Holes

Stalmans P, Benz MS, Gandorfer A, et al; MIVI-TRUST Study Group
N Engl J Med. 2012;367:606-615

A New Agent for Vitreomacular Adhesion

Ocriplasmin (Jetrea®; ThromboGenetics, Inc.; Iselin, New Jersey) recently burst onto the scene to aid in the treatment of vitreomacular adhesion (VMA). Ocriplasmin gained US Food and Drug Administration approval in October 2012. It is formulated as an intravitreal injection, and the first patients received ocriplasmin injections in the United States in January 2013.

VMA can cause visual distortion or reduced acuity, but in some cases it is asymptomatic. VMA can also lead to the development of sight-threatening conditions, such as macular holes. Traditionally, the treatment for symptomatic VMA was vitrectomy, an invasive procedure that carried the risk for retinal detachment and vitreous hemorrhage. The ability to treat VMA before it progresses and begins applying traction to the retina is attractive because it increases the likelihood of a positive outcome while minimizing risks.

Study Summary

Stalmans and colleagues conducted a trial to compare the efficacy of ocriplasmin with sham injection in the treatment of symptomatic VMA. The primary endpoint was resolution of VMA as determined by optical coherence tomography. Ocriplasmin fared better than sham injection; 26.5% of patients receiving ocriplasmin achieved VMA resolution, compared with 10.1% of the sham injection group. Secondary endpoints included achievement of complete vitreous detachment, resolution of macular hole, and improved best-corrected visual acuity by 3 or more lines.

Ocriplasmin was approximately 4 times more likely than sham injection to promote closure of macular holes and to encourage a total vitreal detachment (P < .001). The most relevant endpoints from the patient's perspective, however, are improved visual function and minimal adverse outcomes. Visual acuity gains of 3 lines or more were experienced by 12.3% of patients in the ocriplasmin group compared with 6.3% of the sham injection group. Many patients with VMA have only mild to moderate reductions in visual acuity, so a 3-line gain can be difficult to achieve.

The rate of adverse events was slightly higher in the ocriplasmin group than in the control group (68.4% vs 53.5%), but ocriplasmin was associated with a slightly lower risk for serious adverse events, such as retinal detachment. According to the drug's package insert, a minimal number of patients also experienced lens dislocation and dyschromatopsia after treatment.[1]