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 ]
[ 1 ] . ThromboGenics and Alcon internal estimates[ 2 ] . Idiopathic macular hole. American Academy of Ophthalmology; 2008 [ 3 ] . Stalmans P. Management and intervention strategies for symptomatic vitreomacular adhesions. Retinal Physician 2011 [ 4 ] . Koerner F & Garweg J. Vitrectomy for macular pucker and vitreomacular traction syndrome. Doc Ophthalmol 1999;97:449-458 [ 5 ] . Dugel PU, Brown DM, Humayun MS et al. Symptomatic vitreomacular adhesion: diagnosis, pathologic implications, and management. Retina Today 2011;(Suppl):1-14 [ 6 ] . Stalmans P, Benz MS, Gandorfer A et al. Enzymatic vitreolysis with ocriplasmin for vitreomacular traction and macular holes. N Engl J Med 2012;367:606-615 About JETREA ® (ocriplasmin) JETREA ®(ocriplasmin) is a truncated form of human plasmin. In the US, JETREA ® is indicated for the treatment of symptomatic VMA. In Europe, JETREA ® is indicated for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter ≤ 400 microns. JETREA ® is a selective proteolytic enzyme that cleaves fibronectin, laminin and collagen, three major components of the vitreoretinal interface that play an important role in vitreomacular adhesion. JETREA ® has been evaluated in two multi-center, randomized, double-masked Phase III trials conducted in the U.S. and Europe involving 652 patients with vitreomacular adhesion. Both studies met the primary endpoint of resolution of VMA at day 28. JETREA's Phase III program found that 26.5% of patients treated with ocriplasmin saw resolution of VMA, compared with 10.1% of patients receiving placebo (p<0.01). The Phase III program also showed that JETREA was generally well tolerated with most adverse events being transient and mild in severity.