PRIMA (retinal implant)
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| Field | Value |
|---|---|
| Name | PRIMA (Photovoltaic Retina Implant Micro-Array) |
| Type | Wireless photovoltaic subretinal implant (visual prosthesis) |
| Indication | Geographic atrophy due to age-related macular degeneration (advanced dry AMD) |
| Developer | Daniel Palanker lab, Stanford University (origin); Pixium Vision (development); Science Corporation (current owner) |
| Current owner | Science Corporation (acquired April 2024) |
| Implant size | 2 mm x 2 mm, about 30 micrometers thick |
| Active array | 378 photovoltaic pixels, each 100 micrometers wide |
| Power source | Near-infrared light (880 nm) projected from camera glasses; no wires or battery in the eye |
| Pivotal trial | PRIMAvera (NCT04676854), 38 participants, 17 sites in 5 European countries |
| Key result | 81% of assessed patients gained at least 10 letters of visual acuity at 12 months |
| CE mark | Granted 22 July 2026 (DEKRA, EU Medical Device Regulation) |
| US status | FDA Breakthrough Device and Humanitarian Use Device designations |
PRIMA (Photovoltaic Retina Implant Micro-Array) is a wireless subretinal implant that partially restores central vision in people blinded by geographic atrophy, the advanced form of dry age-related macular degeneration (AMD). A silicon chip 2 mm on a side and about 30 micrometers thick is placed under the retina inside the atrophic lesion, where its 378 photovoltaic pixels convert pulsed near-infrared light into electrical current that stimulates the surviving inner retina. The near-infrared light is projected into the eye by camera-equipped glasses driven by a pocket processor. Developed from research in Daniel Palanker's laboratory at Stanford University, commercialized by the French company Pixium Vision, and acquired by Science Corporation in 2024, PRIMA received a CE mark on 22 July 2026, making it the first device of its kind cleared for commercial sale in Europe.[1][2][3]
What it is
Geographic atrophy is a late stage of dry AMD in which photoreceptors and retinal pigment epithelial cells in the central retina progressively die, leaving a central blind spot (a scotoma) while peripheral vision is usually spared. It affects roughly 5 million people worldwide and accounts for about 20% of all legal blindness in North America.[2] The complement-inhibitor drugs approved for geographic atrophy (pegcetacoplan and avacincaptad pegol) slow the growth of atrophy but do not restore lost vision, and they require repeated intravitreal injections.[2]
PRIMA takes a different approach: instead of protecting cells, it replaces the function of the dead photoreceptors. The implant acts as an array of tiny solar cells that sit in the space the photoreceptors used to occupy and feed electrical signals directly into the retina's remaining bipolar cells, which then relay the signal through the optic nerve to the brain.[2] Science Corporation and the trial investigators describe it as the first treatment shown in a clinical study to restore functional central vision (the ability to read letters, numbers, and words) in patients blinded by geographic atrophy.[1][2] Because it drives a nerve pathway rather than a chemical one, the company and press coverage describe PRIMA as a brain-computer interface; the New England Journal of Medicine, in an accompanying editorial, called it the first treatment to restore vision in advanced geographic atrophy.[4]
How it works
The PRIMA system has three parts: the implanted chip, a pair of glasses with a small camera and an infrared projector, and a handheld pocket processor.[1][2]
The sequence runs as follows. The camera on the glasses captures the scene in front of the patient. The pocket processor converts that image into a pattern of near-infrared light and lets the patient adjust zoom and brightness. A projector on the glasses beams the pattern, as pulsed 880 nm near-infrared light, through the pupil and onto the implant at the back of the eye. Each photovoltaic pixel converts the light that lands on it into a local electrical pulse, which stimulates the nearby inner retinal neurons (bipolar cells). Those cells process the signal and pass it along the optic nerve to the visual cortex, where it is interpreted as an image.[2]
Several design choices matter. The light is near-infrared rather than visible so that it drives the implant strongly without dazzling any residual light sensitivity, and the glasses' lenses are transparent, so patients keep their natural peripheral vision at the same time as the prosthetic central vision.[2] Because the pixels are powered by the projected light itself, the implant needs no wires or battery inside the eye; this is what the developers mean when they call it "wireless" and cite it as an advantage over earlier retinal prostheses that required transscleral cabling.[2] In the trial device the projector ran at a frame rate of 30 Hz, and the processor set the stimulation strength by varying the light pulse duration from 0.7 to 9.8 milliseconds at a peak irradiance of 3.5 milliwatts per square millimeter.[2]
The implant
The PRIMA chip is a thin crystalline silicon array with an area of 2 mm by 2 mm and a thickness of about 30 micrometers, roughly the size of a pinhead and, as the company puts it, about half the thickness of a human hair.[1][2] It carries 378 photovoltaic pixels, each 100 micrometers wide.[2] Each pixel contains an active electrode at its center, a hexagonal return-electrode mesh, and two photodiodes that fill the space between the active and return electrodes and convert the near-infrared light into the current that stimulates the retina.[2]
The 100-micrometer pixel pitch sets a physical ceiling on how fine the restored vision can be. In an implant-resolution test that bypassed the camera and zoom, the mean prosthetic visual acuity was 1.32 logMAR (Snellen equivalent about 20/417), which matches the theoretical limit for 100-micrometer pixels.[2] Researchers in Palanker's group have built and tested arrays with smaller pixels (down to the tens of micrometers) in rodents to probe how much finer the resolution could go, but the human PRIMA device used in the European program uses the 100-micrometer array.[2] Patients recover finer effective acuity than the raw pixel limit by using the glasses' digital zoom, which magnifies the scene before it is projected.[2]
The chip is implanted subretinally, meaning it is slipped into the space beneath the retina, inside the region of atrophy where the photoreceptors have already died. Surgeons place it under the atrophic macula so that it does not damage functioning tissue; in the pivotal trial the mean natural peripheral visual acuity after implantation was equivalent to baseline, indicating patients did not lose their remaining sight.[2]
Background and history
The photovoltaic subretinal approach was developed in the laboratory of Daniel Palanker, a professor of ophthalmology at Stanford University, over more than a decade of preclinical work, including studies in rodent, feline, and non-human primate models.[2] The technology was licensed to and commercialized by Pixium Vision SA, a bioelectronics company based in Paris, France.[3][5]
A first-in-human feasibility trial implanted PRIMA in five patients with geographic atrophy. Its primary endpoint was light perception, but three of the participants went further: after training and optimization they reliably recognized sequences of letters at an acuity close to the 20/420 limit set by the 100-micrometer pixels, and by four years they could read small fonts with a mean Snellen acuity of about 20/135 using zoom.[2] These results led to the larger PRIMAvera confirmatory study.
Pixium Vision ran into financial difficulty and entered court-supervised liquidation in France. In April 2024, Science Corporation, a neurotechnology company founded by former Neuralink co-founder and president Max Hodak, acquired Pixium's PRIMA assets, intellectual property, and ongoing clinical studies, including the 38-patient European pivotal trial (NCT04676854). The deal was announced on 25 April 2024 and cleared by the French commercial court and France's foreign-investment review.[3][5][6] Science said it acquired the program partly to avoid leaving already-implanted trial patients without support and to continue the path to market. Hodak described Pixium's implant as, to his knowledge, the first definitive demonstration of "form vision" in humans.[3][6] In March 2026, Science Corporation raised a $230 million Series C round at a reported valuation of about $1.5 billion, with the PRIMA program among its lead efforts.[7][8]
PRIMAvera pivotal trial
PRIMAvera was an open-label, multicenter, prospective, single-group, baseline-controlled confirmatory study conducted at 17 clinical sites across five European countries. Results were published in the New England Journal of Medicine on 20 October 2025, with Frank G. Holz of the University of Bonn as first author and Daniel Palanker and Jose-Alain Sahel as joint senior authors. The study was funded by Science Corporation and the Moorfields National Institute for Health and Care Research Biomedical Research Centre.[2]
The trial enrolled participants aged 60 or older who had geographic atrophy due to AMD in both eyes and a visual acuity of at least 1.2 logMAR (about Snellen 20/320) in the study eye, with an area of foveal atrophy larger than the implant. The PRIMA array was implanted in 38 participants (18 men, 20 women; mean age 78.9 years). Of these, 32 were assessed at 12 months; of the 6 who were not, 3 had died, 1 withdrew, and 2 were unavailable for testing.[2]
| Endpoint | Definition | Result at 12 months |
|---|---|---|
| Primary efficacy (observed) | Clinically meaningful gain, at least 0.2 logMAR (about 10 letters), baseline to month 12 | 26 of 32 patients (81%; 95% CI 64 to 93; P<0.001) |
| Primary efficacy (imputed) | Same, adjusted for the 6 missing patients | Estimated 80% of all participants (95% CI 66 to 94; P<0.001) |
| Mean acuity gain (PRIMA glasses) | Mean improvement in visual acuity | 0.49 logMAR (about 24.5 letters) |
| Mean acuity gain (patient's choice) | Better of with- or without-glasses reading | 0.51 logMAR (about 25.5 letters) |
| Maximum acuity gain | Best individual result | 1.18 logMAR (59 letters) |
| Prosthetic reading | Read letters, numbers, and words at home | 84% (27 of 32) |
| User satisfaction | Medium-to-high satisfaction with the system | 69% (22 of 32) |
The primary safety endpoint was the number and severity of serious adverse events related to the procedure or device. There were 26 serious adverse events in 19 of the 38 participants. Of these, 21 (81%) occurred within two months after surgery, and 20 (95%) resolved within two months of onset. Four events were classed as severe: a macular hole, ocular hypertension, retinal detachment, and proliferative vitreoretinopathy.[2] Patients could adjust the glasses' zoom and brightness at will during testing, and follow-up under the protocol is planned for up to 36 months after surgery.[2]
The investigators framed the outcome as the first demonstration that a device could restore central vision, not merely slow its loss, in geographic atrophy. The New England Journal of Medicine editorial that accompanied the paper called PRIMA the first treatment to restore vision in patients with advanced geographic atrophy due to AMD.[4]
Regulatory status and commercial launch
Science Corporation submitted its CE-mark application to the European notified body DEKRA on 23 June 2025. The company described the submission as tens of thousands of pages of technical specifications, clinical data, and quality-systems documentation, about 60 GB in digital form.[9] On 22 July 2026, DEKRA granted the CE mark under the EU Medical Device Regulation, authorizing commercial sale across roughly 30 European countries without further country-by-country approval.[1][10] Science says PRIMA is the first brain-computer interface device to receive a CE mark for restoration of detailed form vision.[1]
Chief executive Max Hodak said the company is "proud to be the first BCI company with a CE marked device for restoration of detailed form vision," and trial investigator Frank Holz said that "with PRIMA, we can restore functional central vision in patients blinded by geographic atrophy."[1] According to TechCrunch and Bloomberg, the first commercial procedure is expected in Germany in September 2026, the device is expected to cost in the hundreds of thousands of dollars, and reimbursement discussions with European health systems are ongoing.[10][11] Hodak has cited individual patient milestones from the program, including a patient in France who finished a 300-page novel; these are company accounts rather than trial endpoints.[10]
In the United States, PRIMA has received FDA Breakthrough Device designation (granted in 2023) and Humanitarian Use Device designation, and Science says it is working with the FDA to bring the device to the US market; no US approval date has been announced.[1][9]
Significance and limitations
PRIMA is the first visual prosthesis to show, in a controlled trial published in a major journal, that a subretinal chip can give patients back the ability to read after they have been blinded centrally by AMD. Hodak has compared its potential role in vision to what cochlear implants did for hearing.[8] Because geographic atrophy is common and currently has no vision-restoring treatment, the addressable population is large.[2]
The restored vision is limited and prosthetic, not a return to normal sight. The raw resolution is capped near 20/420 by the 100-micrometer pixel size, and patients reach useful reading acuity only with digital zoom and after training; results vary widely between individuals, from no meaningful change to a 59-letter gain.[2] The procedure is invasive eye surgery and carried serious adverse events in about half of trial participants, though most were surgery-related and resolved within two months.[2] The device also requires the external glasses and processor to function; it does nothing on its own. Longer-term durability data (the protocol follows patients to 36 months) and real-world results outside the trial remain to be reported, and the cost and reimbursement path in Europe are still being worked out.[2][10]
See also
References
- "Science Corp. Announces European Commercial Launch of PRIMA, the Only Treatment to Restore Functional Central Vision to Patients with Geographic Atrophy Caused by Age-Related Macular Degeneration." Business Wire (Science Corporation press release), 22 July 2026. https://www.businesswire.com/news/home/20260722965902/en/ ↩
- Holz FG, Le Mer Y, Muqit MMK, et al. "Subretinal Photovoltaic Implant to Restore Vision in Geographic Atrophy Due to AMD." New England Journal of Medicine, 20 October 2025. DOI: 10.1056/NEJMoa2501396. https://www.nejm.org/doi/10.1056/NEJMoa2501396 ↩
- "Welcoming Pixium Vision's PRIMA retinal prosthesis to Science." Science Corporation, 25 April 2024. https://science.xyz/news/pixium-vision-acquisition/ ↩
- "In Editorial, The New England Journal of Medicine Calls Science Corporation's PRIMA Implant 'The First Treatment to Restore Vision' In Patients Suffering From Advanced Geographic Atrophy Due to Age-related Macular Degeneration." Science Corporation / Business Wire, 14 January 2026. https://science.xyz/news/new-england-journal-of-medicine-prima-editorial/ ↩
- "Science Corporation acquires retinal implant from Pixium Vision." Medical Device Network, April 2024. https://www.medicaldevice-network.com/news/science-acquires-retinal-pixium/ ↩
- "Science Corporation Acquires Pixium's PRIMA Retinal Implant, Extending and Diversifying Its Commitment to Vision Restoration Through Brain-Computer Interface Technology." Business Wire, 25 April 2024. https://www.businesswire.com/news/home/20240425683676/en/ ↩
- "Science Corp. raises $230M as it races to bring its brain implant to market." TechCrunch, 5 March 2026. https://techcrunch.com/2026/03/05/science-corp-closes-230m-round-as-it-pushes-to-get-its-brain-implant-to-patients/ ↩
- "Science Corp. raises $230 million to reverse blindness." Axios, 6 March 2026. https://www.axios.com/2026/03/06/science-blindness-neuralink ↩
- "Science Submits CE Mark Application for PRIMA Retinal Implant, A Critical Step Towards Making It Available To Patients." Science Corporation, June 2025. https://science.xyz/news/prima-ce-mark-application-submitted/ ↩
- "Science Corporation's vision-restoring chip wins EU approval." TechCrunch, 22 July 2026. https://techcrunch.com/2026/07/22/science-corporations-vision-restoring-chip-wins-eu-approval/ ↩
- "Retina Chip Designed to Restore Sight to Go on Sale in Europe." Bloomberg, 22 July 2026. https://www.bloomberg.com/news/articles/2026-07-22/ ↩
- "PRIMAvera study: Central vision improvement with subretinal implant." Ophthalmology Times, 2025. https://www.ophthalmologytimes.com/view/primavera-study-central-vision-improvement-with-subretinal-implant
- "PRIMA Implant Shows Clinical Potential." Retinal Physician, May/June 2026. https://www.retinalphysician.com/issues/2026/may-june/prima-implant-shows-clinical-potential/
- "Science Corp., Another Braintech Startup Founded By Neuralink Alums, Raises $230M Series C." Crunchbase News, March 2026. https://news.crunchbase.com/venture/braintech-ai-startup-science-neuralink-alums-seriesc/
- "Science Corp. Announces European Commercial Launch of PRIMA." BioSpace, 22 July 2026. https://www.biospace.com/press-releases/science-corp-announces-european-commercial-launch-of-prima/
- "PRIMA retinal implant restores vision in patients with advanced GA." Ophthalmology Times, October 2025. https://www.ophthalmologytimes.com/view/prima-retinal-implant-restores-vision-in-patients-with-advanced-ga
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