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Comparison of ocriplasmin efficacy and treatment guidance as determined by European regulatory agencies
Author(s) -
KOROBELNIK J
Publication year - 2014
Publication title -
acta ophthalmologica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.534
H-Index - 87
eISSN - 1755-3768
pISSN - 1755-375X
DOI - 10.1111/j.1755-3768.2014.4673.x
Subject(s) - medicine , macular hole , health authority , optometry , epiretinal membrane , visual acuity , vitrectomy , ophthalmology , nursing
Purpose Ocriplasmin, a truncated form of human plasmin, has proteolytic activity against components of the vitreous body and the vitreoretinal interface. Methods Results from placebo‐controlled trials designed to determine efficacy and safety of ocriplasmin for the treatment of VMT were used in the determination by the French National Health Authority (Haute Autorité de Santé, or HAS), the National Institute for Health and Care Excellence (NICE), and the Isntitute for Quality and Efficiency in Healthcare (Institut fur Qualitat und Wirtschaftlichkeit im Gesundheitswesen, or IQWiG). Different subgroups according to presence or absence of anatomic features and visual acuity (VA) were analysed. Results All 3 regulatory agencies recommend ocriplasmin for the treatment of VMT including when associated with MH less than or equal to 400 microns. The HAS recommends ocriplasmin for the treatment of adult patients with VMT for whom symptomatology does not require immediately a vitrectomy, at the earlier stage of disease. IQWiG reported indication of an added benefit for patients with mild (VA >60 ETDRS letters) to moderate visual impairment (VA 35‐60 ETDRS letters). According to the NICE guidance, ocriplasmin is recommended as an option for treating VMT in adults only if an epiretinal membrane is absent, with or without severe symptoms. Conclusion The benefit of ocriplasmin for the treatment of VMT including when associated with FTMH of 400 microns or less has been evaluated and confirmed by Europe’s leading regulatory agencies. Minor differences exist in the recommendations from each country, based on anatomic features (absence of ERM), visual acuity, and severity of symptoms.