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Macular degeneration

Landmark Clinical Trial Results Published in Peer-Review Journal Demonstrate Efficacy of PRIMA Brain-Computer Interface Retinal Implant

Strategic Insights

— 2 min read

A groundbreaking clinical trial has resulted in the publication of a peer-reviewed original paper in the New England Journal of Medicine, showcasing the effectiveness of Science Corporation's PRIMA brain-computer interface (BCI) retinal implant. The study demonstrated that PRIMA restored functional central vision to patients suffering from geographic atrophy (GA) due to age-related macular degeneration (AMD), a leading cause of blindness affecting over 5 million people worldwide. This innovative technology represents a paradigm shift in treating late-stage AMD, offering new hope to patients in need.

Key Takeaways:

  • The PRIMA implant system was evaluated in a multi-center clinical trial involving 38 patients across 17 clinical sites in five countries.
  • The study demonstrated a mean improvement of 25.5 letters (more than 5 lines) on the ETDRS letter chart, with 84% of patients able to read letters, numbers, and words, restoring functional central vision.
  • 80% of patients achieved significant prosthetic visual acuity improvements of at least logMAR 0.2 (equivalent to 10 letters on the ETDRS chart) at 12 months (p<0.01).
  • The implant was safely implanted under the atrophic macula, with no significant decline in mean existing peripheral natural vision observed.
  • "Serious adverse events" occurred primarily within the first two months post-implantation and 95% of these resolved within 2 months.
  • The Data Safety Monitoring Board for the study recommended PRIMA for European market approval, finding that the benefits to patients outweighed the risk of the implantation surgery.

Statistics:

  • 84% of patients reported the ability to read letters, numbers, and words, restoring functional central vision.
  • 80% of patients demonstrated significant prosthetic visual acuity improvements of at least logMAR 0.2 (equivalent to 10 letters on the ETDRS chart) at 12 months (p<0.01).
  • The PRIMA implant system was implanted in 38 patients across 17 clinical sites in five countries.
  • "Serious adverse events" occurred in 5% of patients, with 95% resolving within 2 months.

Sources:

  • New England Journal of Medicine
  • Science Corporation
  • Prof. Daniel Palanker at Stanford University
  • Dr. Frank Holz, lead author of the NEJM paper and Chair of the Department of Ophthalmology at the University Hospital of Bonn
  • Max Hodak, founder and CEO of Science Corporation
  • Prof. Jose-Alain Sahel, M.D, senior co-author of the paper from the Department of Ophthalmology, University of Pittsburgh School of Medicine, Pittsburgh; Sorbonne Universite, Paris; and Institut de la Vision, Paris
  • Mahi Muqit, PhD FRCOphth, a consultant vitreoretinal surgeon at Moorfields Eye Hospital in London and co-author of the paper

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