Notification report

Full notification file

General information

Notification Number

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

Title of the Project
Efficacy and Safety of Bilateral Intravitreal Injection of GS010: A Randomized, Double-Masked, Placebo-Controlled Trial in Subjects Affected with G11778A ND4 Leber Hereditary Optic Neuropathy for Up to One Year.

Proposed period of release:
01/01/2018 to 30/03/2021

Name of the Institute(s) or Company(ies)
GENSIGHT Biologics, 74 rue du Faubourg Saint-Antoine
75012 Paris

3. Is the same GMO release planned elsewhere in the Community?
Belgium; Germany; France; United Kingdom; Italy; Netherlands;

Has the same GMO been notified elsewhere by the same notifier?

If yes, notification number(s):

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Genus: Dependovirus
Species: AAV-derived replication-deficient vector

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
AAV2DependovirusAdeno-associated Virus-serotype 2-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known