Brief: GenSight Biologics Provides Update On European Medicines Agency Scientific Advice For LUMEVOQ®

Gensight Biologics SA

27/09/2023 06:55

Sept 27 (Reuters) - Gensight Biologics SA  SIGHT.PA :
    * GENSIGHT BIOLOGICS PROVIDES UPDATE ON EUROPEAN MEDICINES
AGENCY
SCIENTIFIC ADVICE FOR LUMEVOQ®
    * TWO-ARM PHASE III TRIAL WITH SHAM CONTROL ARM VERSUS.
LUMEVOQ®
BILATERAL INJECTION CONSIDERED ACCEPTABLE FOR ASSESSING EFFICACY
    * OPEN-LABEL PROVISION TO PROVIDE LUMEVOQ® BILATERAL
TREATMENT TO
SHAM SUBJECTS AFTER POSITIVE PRIMARY ANALYSIS
    * GENSIGHT TO CONTINUE DISCUSSIONS WITH EMA AND OTHER
REGULATORY
AUTHORITIES TO DEFINE OPTIMAL PATH TO MARKETING AUTHORIZATION
FOR LUMEVOQ®

Source text for Eikon: [ID: nBwc0LbM0a]
Further company coverage:  SIGHT.PA 

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