Science Corp, an Alameda-based company, is actively working to commercialize its PRIMA retinal implant, a device initially developed by Dr. Daniel Palanker and his team at Stanford University. The company is currently targeting European regulatory clearance, specifically the CE Mark, and anticipates a decision regarding their application next year. This approval would allow Science Corp to market PRIMA across over 30 European countries, a significant market for medical devices. The CE Mark indicates compliance with European Union health and safety standards.
In Europe, clinical trials have shown promising results. A major European clinical trial demonstrated that some patients with central vision loss due to macular degeneration were able to intuitively read again, recognize playing cards, and complete crossword puzzles. Results from a trial published in the New England Journal of Medicine, involving 32 participants, indicated that 26 of them experienced meaningful vision improvement after one year, with patients gaining an average of five lines on a standard eye chart. One participant reportedly improved by 12 lines, with some patients who could previously only perceive the largest letter now able to read large print and perform daily tasks independently.
For the U.S. market, PRIMA received FDA Breakthrough Device status in 2023. Science Corp has also requested Humanitarian Use Device Designation to bring this technology to American patients sooner, with ongoing discussions with the FDA to determine the appropriate translational pathway. While U.S. FDA approval is expected to take longer, the humanitarian device exemption is a strategic route to ensure earlier access for patients in need. The PRIMA implant is a 2mm, 370-pixel chip powered by near-infrared light, designed to stimulate surviving retinal cells in individuals with severe central vision loss due to advanced age-related macular degeneration (AMD) with geographic atrophy.
