Dermatologic and Ophthalmic Drugs
Advisory Committee
NDA# 21-414, Vitráse
(hyaluronidase for intravitreal
injection)
D R A F T
Are additional
analyses of the data needed to understand the safety or efficacy of Vitráse for the
treatment of
vitreous hemorrhage?
Are additional
studies needed to establish the efficacy of this product?
Has sufficient
evidence been submitted to support the efficacy of Vitráse
for the treatment of
vitreous hemorrhage?
Is there concern
about the death rate observed in these studies?
What additional
clinical studies would be helpful in further evaluating the potential benefits
of
Vitráse therapy?
Are there adverse
experiences that are of particular concern for this product?
Does the committee
recommend approval of Vitráse for the treatment of
vitreous hemorrhage?