Brief: Pixium Vision Announces Reaching Its Enrollment Target In European Pivotal Trial Primavera

Pixium Vision SA

19/09/2022 06:04

Sept 19 (Reuters) - Pixium Vision SA  ALPIX.PA :
    * PIXIUM VISION ANNOUNCES REACHING ITS ENROLLMENT TARGET IN
THE
EUROPEAN PIVOTAL TRIAL PRIMAVERA AND IMPLANTATIONS PLANNED TO BE
COMPLETED BY END 2022
    * TARGET NUMBER OF 38 PATIENTS HAVE BEEN ENROLLED AT
CLINICAL
SITES IN FRANCE, GERMANY, UK, NETHERLANDS, AND ITALY
    * IMPLANTATIONS DUE TO BE COMPLETED BY END OF 2022;
PRIMAVERA
READ-OUT EXPECTED AROUND END OF 2023
    * WAITING LIST FOR ADDITIONAL PATIENTS INITIATED TO REPLACE
POTENTIAL PRE-IMPLANTATION DROP-OUTS AND INELIGIBILITY
    * PRIMARY EFFICACY ENDPOINT OF PRIMAVERA STUDY IS PROPORTION
OF
SUBJECTS WITH AN IMPROVEMENT OF VISUAL ACUITY OF LOGMAR 0.2 OR
MORE FROM BASELINE AFTER 12 MONTHS
    * PRIMARY SAFETY ENDPOINT IS NUMBER AND SEVERITY OF DEVICE
AND
PROCEDURE-RELATED SERIOUS ADVERSE EVENTS AT 12 MONTHS FOLLOW-UP

Source text for Eikon:  ID:nGNE1CDKhy 
Further company coverage:  ALPIX.PA 

 (Gdansk Newsroom)
 ((gdansk.newsroom@thomsonreuters.com; +48 58 769 66 00;))