Stargardt disease, a rare inherited eye disease, usually starts taking central vision in childhood and has no treatment that restores what is lost. On 13 October, Science Corporation said the first person with the disease to receive its PRIMA retinal implant saw a letter in his first rehabilitation session and read a word in his second. It is the first clinical result the company has reported from PRIMA outside geographic atrophy, the form of age-related macular degeneration the implant is sold for in Europe and the UK.
The evidence is thin so far. It covers one patient’s first two training sessions, comes only from the company and a video, and has not been published. Science has not given the size of the letter or word, the patient’s visual acuity, or whether he could read with the implant’s glasses switched off. Participants can enter the trial with vision as good as 20/320 in the study eye, so some natural sight may remain.
The trial
The patient was implanted in May in PRIMAlia, a trial at Sydney Eye Hospital led by Matthew Simunovic, head of the Save Sight Institute’s Retinal Disease and Rescue Group. The institute announced the trial and showed the first surgery in June without naming the first patient’s condition or giving any result. Sponsored by Science, PRIMAlia began on 22 April 2026 and plans to enrol five adults with inherited retinal degeneration affecting the macula in both eyes, including Stargardt disease and retinitis pigmentosa. Its main measures, at 12 months, are the share of participants whose visual acuity improves by at least 0.2 logMAR, about two lines on an eye chart, and the number and severity of serious adverse events related to the device or the procedure. The registry gives an estimated primary completion date of March 2029.
PRIMA is a chip 2 millimetres by 2 millimetres placed under the retina where the light-sensing photoreceptor cells have died. Camera glasses project the scene onto it in near-infrared light, and its photovoltaic pixels turn that light into electrical signals that the surviving retinal cells pass on to the brain. Stargardt disease and geographic atrophy both destroy the light-sensing cells in the macula, the centre of the retina, while the inner retina can be spared. Science puts the number of people worldwide who have lost vision to Stargardt disease at about 150,000.
The commercial picture
PRIMA has been on sale in Europe since July for patients blinded by geographic atrophy and is registered for supply in the UK. In the United States it holds a Breakthrough Device designation and Humanitarian Use Device designations for advanced geographic atrophy and for Stargardt disease, a status reserved for conditions affecting no more than 8,000 people a year there. The designation opens a route to approval, the Humanitarian Device Exemption, that waives proof of effectiveness and restricts profit and use. Science said in March that it had applied to the FDA for approval, and on 5 October described PRIMA as pending FDA approval.
Speaking at TechCrunch Disrupt on 13 October, chief executive Max Hodak said the next step is a bigger implant with a wider field of view, and that a next-generation device now in development will be in humans within the next year.
Not disclosed
Science has not published the patient’s acuity before or after implantation, any data from other PRIMAlia participants, or how many PRIMAlia participants have been implanted so far. It has not said which condition its pending US application covers or when it expects an FDA decision.
What to watch
Whether Science publishes acuity data from PRIMAlia, including from patients with retinitis pigmentosa.
Whether the FDA approves PRIMA through a Humanitarian Device Exemption, and whether approval covers geographic atrophy, Stargardt disease or both.
Whether the next-generation PRIMA implant reaches patients within the year Hodak described.
Sources
Primary:
- Science Corporation: Clinical trial update, first patient with Stargardt disease using PRIMA (video), 13 October 2026
- Science Corporation: PRIMA has received Humanitarian Use Device designations from the US Food and Drug Administration, 22 July 2026
- Science Corporation: European commercial launch of PRIMA, 22 July 2026
- ClinicalTrials.gov: NCT07266584, Restoration of central vision with PRIMA in patients with photoreceptor degeneration (PRIMAlia)
- Save Sight Institute, University of Sydney: New device hopes to restore vision lost from retinal degeneration, 16 June 2026
- Science Corporation: Science closes $230 million Series C, 5 March 2026
- Science Corporation: long-term (36 months) results of PRIMA clinical trial, 5 October 2026
- US Food and Drug Administration: Humanitarian Device Exemption
- National Eye Institute: Stargardt disease
Coverage:
Cross-reference to prior InsideBCI coverage: