A Stargardt patient implanted in Sydney recognised a letter in his first rehabilitation session. This is the first case of this disease with the PRIMA device.
According to ecosistemastartup.com, a man implanted in May at the Sydney Eye Hospital in Australia recognised a letter in his first rehabilitation session and read a word in the second. He is the first patient with Stargardt disease to use the retinal implant PRIMA, from the company Science Corp, which announced it on October 13 on its website.
The case involves a single patient and there are no published trial results for this indication. However, the technology has a published trial in the New England Journal of Medicine and three-year follow-up data, which sustain the sector's interest.
PRIMA is a subretinal implant measuring 2 × 2 millimetres and 30 microns thick, with 378 photovoltaic pixels that convert light into electrical signals. The patient uses glasses with a camera that project infrared light of 880 nanometres and allow the image to be magnified between 1 and 12 times. The chip does not require a battery or cables.
The technology comes from the French company Pixium Vision, which Science Corp acquired in April 2024 along with three ongoing clinical studies, according to New Atlas. The approach was conceived in 2005 by Professor Daniel Palanker from Stanford.
The case is part of the PRIMAlia trial, registered as NCT07266584, being conducted in Australia and overseen by Dr. Matthew Simunovic. The company has not disclosed how many patients will participate. Science Corp estimates the prevalence of Stargardt disease at 1 in 10,000 people.
In the United States, PRIMA is not approved: the FDA has granted it humanitarian use device designation for geographic atrophy and Stargardt disease. In the European Union, it has CE marking for geographic atrophy, according to MassDevice, and New Atlas indicates that the certification allows its sale in 30 European countries.
The pivotal trial PRIMAvera, published in the New England Journal of Medicine in October 2025, implanted 38 patients with geographic atrophy across 17 centres in 5 European countries. Of the 32 evaluable at 12 months, 26 showed clinically significant improvement, with an average gain of 24.5 letters.
The company presented data at 36 months that have not yet been published in a journal on October 5 at the EURETINA congress in Vienna: an average gain of 29 letters and 14 of the 18 evaluable patients with at least 15 letters gained. The presentation was made by Mahi Muqit, vitreoretinal surgeon at Moorfields Eye Hospital. The CEO of Science Corp, Max Hodak, summarised it as follows:
In clinical trials, PRIMA works better at month 36 than at month six
According to Ophthalmology Times, of the 29 serious adverse events recorded in 38 patients, 83% occurred in the first six months, and most were related to complications from vitreoretinal surgery rather than the device.
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