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CME

FDA Approvals: Ocriplasmin for Vitreomacular Adhesions

  • Authors: News Author: Troy Brown
    CME Author: Laurie Barclay, MD
  • CME Released: 10/31/2012
  • THIS ACTIVITY HAS EXPIRED
  • Valid for credit through: 10/31/2013
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Target Audience and Goal Statement

This article is intended for primary care clinicians, pharmacists, ophthalmologists, and other specialists who care for patients with symptomatic vitreomacular adhesions.

The goal of this activity is to provide medical news to primary care clinicians and other healthcare professionals in order to enhance patient care.

Upon completion of this activity, participants will be able to:

  1. Describe efficacy data leading to FDA approval of ocriplasmin intravitreal injection for the treatment of vitreomacular adhesions.
  2. Describe adverse effects of ocriplasmin intravitreal injection.
  3. Describe other risk-benefit concerns related to use of ocriplasmin intravitreal injection.


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Author(s)

  • Troy Brown

    Troy Brown is a freelance writer for Medscape.

    Disclosures

    Troy Brown has disclosed no relevant financial relationships.

Editor(s)

  • Laurie E. Scudder, DNP, NP

    Nurse Planner, Continuing Professional Education Department, Medscape, LLC; Clinical Assistant Professor, School of Nursing and Allied Health, George Washington University, Washington, DC

    Disclosures

    Disclosure: Laurie E. Scudder, DNP, NP, has disclosed no relevant financial relationships.

CME Author(s)

  • Laurie Barclay, MD

    Freelance writer and reviewer, Medscape, LLC

    Disclosures

    Disclosure: Laurie Barclay, MD, has disclosed no relevant financial relationships.

CME Reviewer(s)

  • Sarah Fleischman

    CME Program Manager, Medscape, LLC

    Disclosures

    Disclosure: Sarah Fleischman has disclosed no relevant financial relationships.


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CME

FDA Approvals: Ocriplasmin for Vitreomacular Adhesions

Authors: News Author: Troy Brown CME Author: Laurie Barclay, MDFaculty and Disclosures
THIS ACTIVITY HAS EXPIRED

CME Released: 10/31/2012

Valid for credit through: 10/31/2013

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Clinical Context

The US Food and Drug Administration (FDA) has approved ocriplasmin intravitreal injection for the treatment of symptomatic vitreomacular adhesions (VMAs), providing the first nonsurgical treatment alternative. At its July 26 meeting, the advisory committee voted unanimously to recommend approval of ocriplasmin for the treatment of VMAs. Although the committee also voted 7 to 3 to recommend approval for the treatment of macular holes, the FDA announcement does not mention approval for this indication.

Study Synopsis and Perspective

The FDA approved ocriplasmin intravitreal injection (Jetrea) for the treatment of symptomatic VMAs, the agency announced.

"[The October 18] approval represents a significant advancement in treatment for patients with symptomatic VMA," said Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research. "Those with this sight-threatening disease now have a nonsurgical treatment option."

The decision follows a July 26 advisory committee meeting at which the committee voted unanimously to recommend approval of ocriplasmin for the treatment of VMAs and also voted 7 to 3 to recommend approval for the treatment of macular holes. The FDA announcement does not mention macular holes.

Richard Spaide, MD, a clinical correspondent for the American Academy of Ophthalmology and a retina-macular specialist with Vitreous-Retina-Macula Consultants of New York City, commented on the development for Medscape Medical News in an email interview.

"Ocriplasmin offers the opportunity to treat symptomatic vitreomacular adhesion and traction without the need for vitrectomy. There are a number of potential research opportunities to evaluate if release of vitreous adhesions would change the clinical course of a variety of diseases such as diabetic macular edema and choroidal neovascularization, and to evaluate if release of traction influences treatment response," Dr. Spaide said.

K. Bailey Freund, MD, a clinical correspondent for the American Academy of Ophthalmology, also commented on the approval in a telephone interview with Medscape Medical News. Dr. Freund is a retina specialist with Vitreous-Retina-Macula Consultants of New York City and a clinical associate professor of ophthalmology at New York University School of Medicine in New York City.

"I'm not aware of anything that's gone into late-phase clinical trials similar to ocriplasmin," said Dr. Freund.

The advisory committee relied on 2 studies that enrolled a combined total of 652 patients: 464 patients were randomly assigned to receive a single intravitreal injection of ocriplasmin 125 μg, and 188 patients received a placebo injection. Patient assessments were conducted at baseline, on injection day, and 7, 14, 28, 90, and 180 days postinjection. Investigators could recommend vitrectomy at any time if they felt the patient required it.

A total of 26.5% of the patients in the ocriplasmin group met the primary endpoint of nonsurgical VMA resolution at day 28 compared with 10.1% of those in the placebo group.

The percentage of patients with total posterior vitreous detachment was higher in the ocriplasmin group (13.4%) vs the placebo group (3.7%; odds ratio [OR], 4.27; 95% confidence interval [CI], 1.89 - 11.32; P < .001).

The percentage of eyes with nonsurgical closure of macular hole was higher in the ocriplasmin group (40.6%) vs the placebo group (10.6%; OR, 5.94; 95% CI, 20.9 - 21.01; P < .001).

The percentage of patients who required vitrectomy was lower in the ocriplasmin group (17.7%) vs the placebo group (26.6%; OR, 0.61; 95% CI, 0.40 - 0.94; P = .02).

Overall, the percentage of patients who experienced best-corrected visual acuity improvement of 3 or more lines on an eye chart was higher in the ocriplasmin group (12.3%) vs the placebo group (6.4%; OR, 2.09; 95% CI, 1.08 - 4.41; P = .02).

For patients who did not require vitrectomy, the corresponding values were 9.7% vs 3.7%.

Risk-Benefit Concerns

The incidence of ocular adverse events (conjunctival hemorrhage, vitreous floaters, photopsia, and injection-related pain) was higher in the ocriplasmin group (68.4%) vs the placebo group (53.5%; P < .001).

The incidence of more serious ocular adverse events including retinal tear or detachment was 7.7% in the ocriplasmin group vs 10.7% in the placebo group (P = .26).

"The majority of patients who receive this drug will not get benefit from the drug, and I think that that needs to be very clearly stated. If the drug is approved, it must be very clearly stated in labeling...even though there is efficacy benefit over risk," voting committee member Lynn Gordon, MD, PhD, a professor of ophthalmology at Jules Stein Eye Institute and associate dean of diversity affairs at David Geffen School of Medicine at the University of California, Los Angeles, said at the July 26 meeting.

"You'll have to be careful counseling patients and say that, 'this is definitely worth a try, and could potentially avoid a much more invasive procedure, but the chances are, based on the results of the trial...you're still going to need surgery,' " Dr. Freund said.

"The eyes that it worked best on were very specific types...eyes without epiretinal membrane, eyes with small holes. You should look at this data, and it's probably not appropriate to inject it on the other types of situations that were studied," Dr. Freund added.

Dr. Spaide said ocriplasmin is likely to be expensive. "The costs related to developing the drug and doing the clinical trials [have] to be covered. The costs of the drug are likely to temper the 'let's give the drug and see what happens' approach for certain diseases," said Dr. Spaide.

He believes insurance companies will approve reimbursement for treatment of VMAs and macular holes, but not for other uses like diabetic macular edema, where it might be helpful. "Insurance companies may hold off on approving the costs of the drug until better data is available. The drug labeling may be restricted to cover only a select list of conditions at first. I think the reimbursement issues are going to be interesting," Dr. Spaide noted.

More information on the ocriplasmin announcement is available on the FDA Web site.

Dr. Freund has disclosed no relevant financial relationships. Dr. Spaide receives royalties from Topcon and is a consultant to Topcon, Optos, and Thrombogenics.

Clinical Implications

  • In 2 studies leading to FDA approval of ocriplasmin intravitreal injection for the treatment of VMAs, superior outcomes with ocriplasmin vs placebo included a higher proportion of patients with nonsurgical resolution of VMA at day 28, a higher proportion of patients with nonsurgical closure of macular hole, a lower percentage of patients who required vitrectomy, and a higher percentage of patients who experienced best-corrected visual acuity improvement of at least 3 lines.
  • In these 2 studies leading to FDA approval of ocriplasmin, the overall incidence of ocular adverse events was significantly higher in the ocriplasmin group vs the placebo group. However, the incidence of more serious ocular adverse events, including retinal tear or detachment, was not significantly different between groups.
  • Clinicians should counsel their patients that most will not benefit from the drug, and those who do not will ultimately require surgery. However, use of the drug may spare some patients a much more invasive procedure. The likelihood of successful treatment with ocriplasmin is best for eyes without epiretinal membrane and those with small holes. Ocriplasmin is likely to be expensive.

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