OSLI Retina

March/April 2013

Issue link: http://osliretina.healio.com/i/131340

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Practical Retina Incorporating current trials and technology into clinical practice Ocriplasmin: Nonsurgical option for VMA and macular hole, but with potential barriers to practical use by Michael D. Ober, MD Seenu M. Hariprasad Practical Retina Editor In our first Practical Retina, Dr. Michael Ober from Southfield, Mich., was asked to comment on the FDA registration trials leading to the approval of ocriplasmin, or Jetrea, for symptomatic vitreomacular adhesion (sVMA). This unique agent is slated to be a very important tool to address the "wait and see" population of patients who have sVMA. These patients are not yet candidates for vitrectomy surgery because their relatively good vision does not warrant surgical risks. Jetrea is unique from our other currently available intravitreal agents as it is an enzyme. This requires specialized handling and storage. Furthermore, theoretically, location of injection may play a role in efficacy. Lastly, given the unique mechanism of action, there may be a side effect profile unique to this agent compared to our other commonly used intravitreal injections. Dr. Ober will comment on Jetrea — the first commercially available, FDA-approved intravitreal injection that is a proteolytic enzyme indicated for the treatment of symptomatic vitreomacular adhesion. Seenu M. Hariprasad, MD The introduction of Jetrea (ocriplasmin, ThromboGenics) represents the first pharmacological treatment option for symptomatic vitreomacular adhesion, including vitreomacular traction and macular holes. This drug has the potential to expand our treatment indications to include patients whose disease was previously addressed either through surgery or a wait-and-see approach. In particular, this drug offers a new option Michael D. Ober for patients in whom the risks of surgery were thought to outweigh the potential benefits. Because the high threshold for surgery has historically excluded patients with mild disease, the standard of care has been based on monitoring for progression. In these cases, patients with visual symptoms now have a lower-risk option to address their condition at an earlier stage. However, we await real world experience to determine how beneficial a product this will ultimately be. Before incorporating this drug into their practices, retinal specialists will need to weigh the advantages against the potentially significant barriers to widespread adoption. OCRIPLASMIN BENEFITS Ocriplasmin is a truncated form of the human serine protease plasmin. This recombinant protease dissolves the proteins that adhere the vitreous to the retina and is administered by intravitreal injection. It has been studied in two phase 3 trials involving 652 patients with vitreomacular adhesion (VMA). These studies found that 26.5% of patients treated with ocriplasmin experienced resolution of VMA at 28 days, compared with 10.1% of patients receiving placebo (P < .01).1 Ocriplasmin achieved nonsurgical closure of macular holes in 40.6% of injected eyes, compared with 10.6% of placebo-injected eyes doi: 10.3928/23258160-20130313-02 March/April 2013 • Vol. 44, No. 2 113

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