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Vitreomacular traction resolved in one-third of patients treated with ocriplasmin (Jetrea, ThromboGenics) within 28 days in a phase IV study of the new medication, according to Dr David Steel.
By Laird Harrison
Nice, France-Vitreomacular traction resolved in one-third of patients treated with ocriplasmin (Jetrea, ThromboGenics) within 28 days in a phase IV study of the new medication, according to Dr David Steel.
Vitreomacular traction can reduce visual acuity and cause metamorphopsia and central field defect, he reminded the audience. It is believed that ocriplasmin treats this condition by cleaving fibronectin, laminin and collagen in the vitreous body and vitreoretinal interface, explained Dr Steel, a consultant ophthalmologist and vitreoretinal surgeon at Sunderland Eye infirmary in the United Kingdom. Dr Steel presented the finding at the European Society of Retina Specialists 15th EURETINA Congress.
In two phase III controlled trials, ocriplasmin resolved vitreomacular adhesion and vitreomacular traction in 26.5% of cases within 28 days. By comparison, only 10.1% of cases treated with a placebo resolved in that amount of time (N. Engl. J. Med. 2012;367(7):606-615). Based on these trials, the US Food and Drug Administration approved ocriplasmin for vitreomacular traction and symptomatic vitreomacular holes in October 2012. The European Medicines Agency approved it in March 2012 for the treatment of vitreomacular traction, including cases associated with a macular hole of less than 400µm.
Researchers wanted to know how safe and effective the treatment would be in the ‘real-world’ of clinical practice. To answer that question, they followed 105 patients at multiple centers in Europe. Sixty-four of these patients had vitreomacular traction only and 41 had vitreomacular traction with macular holes. The patients each received one intravitreal injection of 0.125mg ocriplasmin. The population was 61.9% female, and had an average age of 72.2 years. Ninety-seven per cent were white.
At baseline, 7.3% of participants had epiretinal membranes. The researchers classified 97.4% of vitreomacular adhesion cases as focal (less than 1500 µm), and the rest as broad (greater than 1500µm). The sizes of the macular holes were broken down into small (less than 250µm, 33.3%), medium (between 250 and 400µm, 64.1%) and large (greater than 400µm, 2.6%).
After 28 days of follow-up, vitreomacular traction resolved in 30% of the total cohort of patients. None of the cases of broad vitreomacular adhesion resolved, but 32% of the focal vitreomacular adhesion cases resolved. Similarly, none of the cases with epiretinal membrane resolved, but 39% of those without epiretinal membrane did.
More than 2% of patients experienced treatment-related emergency adverse events. Of these, eight patients reported that the drug was ineffective, seven experienced photopsia, seven had vitreous floaters and five said they had reduced visual acuity. Six treatment-emergent adverse events were deemed serious. Four patients developed macular holes, four developed retinal detachment and two developed retinal tears (one of the tears occurred alone and one occurred in combination with retinal detachment).
“This is just an interim report,” Dr Steel concluded. “One-year results will be available next autumn, and that will give us more information on the safety aspects and the clinical efficacy in the real world.”
In the question-and-answer period, session moderator Marc D de Smet, who invented ocriplasmin, asked whether the researchers had broken out results in patients with adhesion areas of 400µm or less. Dr Steel responded that the information was not available for this study. This result could be important, Dr de Smet explained later to Ophthalmology Times Europe, because some other post-market studies have suggested resolution rates as high as 70% in cases with such small adhesion areas.
The treatment costs about €4,000, which is close to the cost of surgery, said Dr de Smet, who currently practices at Microinvasive Ocular Surgery – retina and inflammation in Lausanne, Switzerland. If physicians can only offer a 30% rate of resolution, that may not be an attractive proposition to many patients, he pointed out.
Dr de Smet added that it would be helpful to know whether patients’ eyesight improved in this study.
“There are cases – I’ve had some – where when you inject, you don’t get the complete separation of the vitreous, but you do get improvement in vision,” he said. “These studies are important to determine in the real world what are the real risks of visual loss due to the effects of the drug under the retina,” he added. “Those risks are apparently very small. I think it’s a drug that has its place if you avoid patients that have pathologies that are at risk of being complicated by a fairly fast vitreous detachment.”