The Data Safety Monitoring Board for the PRIMAvera clinical trial announced on November 13, 2024 its unanimous conclusion that the Science PRIMA retina implant clinical trial results had met all the data safety monitoring standards necessary for it to receive a recommendation for European Union CE mark. The Board found that the benefits to patients of the device outweighed any adverse impact risks, thus helping to pave the way for its entry into the consumer market.
DSMB chair Sebastian Wolf said: “After carefully reviewing the data from the PRIMAvera trial, we are confident to recommend the PRIMA implant for CE mark submission. We are pleased to see this product make a future positive impact on patient lives.”
The Data Safety Monitoring Board for the PRIMA Implant is an independent body composed of three outstanding experts in the field of ophthalmology. They are:
- Sebastian Wolf, M.D., PhD – Managing Director, Bern Photographic Reading Center, Dept. Ophthalmology, University Hospital, University of Bern, Bern, Switzerland.
- Sophie J. Bakri, M.D. – Chair of Ophthalmology at Mayo Clinic in Rochester, Minnesota.
- Thomas Wolfensberger, M.D. – Director of the Vitreoretinal Department of the Jules Gonin Eye Hospital of the University of Lausanne, Switzerland
Science Director of Clinical Affairs Dr. Ralf Hornig said: “The DSMB has confirmed that the PRIMAvera data meets all the necessary requirements. We are thrilled that this brings us one major step closer to being able to get the PRIMA Implant to many patients who desperately need it.”
The next step for the company is to submit the full CE mark application to its notified body, DEKRA, for review. Consisting of over a thousand pages of regulatory documentation, the application is expected within the next two quarters.
