The EU MAA submission was based on data from two pivotal phase III clinical trials that evaluated the safety and efficacy of a single administration of JETREA ®. Both studies met their primary endpoint and demonstrated that JETREA ® successfully resolved VMT and macular holes compared to placebo.All adverse reactions were ocular. The most commonly reported were vitreous floaters, eye pain and photopsia, as well as conjunctival haemorrhage resulting from the injection procedure. Most of the adverse reactions occurred within the first week after the injection. The majority of these reactions were non-serious, mild in intensity and resolved within 2 to 3 weeks. [ 6 ]
ThromboGenics' JETREA® Granted EU Approval For Vitreomacular Traction (VMT), Including When Associated With Macular Hole Of Diameter Less Than Or Equal To 400 Microns
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