Review of: Subretinal photovoltaic implant to restore vision in geographic atrophy due to AMD
Holz F, Le Mer Y, Muqit M, et al. New England Journal of Medicine, October 20, 2025
This study investigated the use of a photovoltaic retina implant microarray (PRIMA) system (Science Corporation), a wireless subretinal implant coupled with near-infrared light–emitting glasses, and its ability to improve visual acuity in eyes with geographic atrophy (GA) due to age-related macular degeneration (AMD).
In this open-label, multicenter, prospective, single-group clinical trial, 38 patients with GA were outfitted with the PRIMA system implant and glasses. All patients had foveal-involving GA lesions >2.4 mm in diameter (larger than the implant) and visual acuity of at least 1.2 logMAR (~20/300). The primary efficacy endpoint was clinically significant improvement in visual acuity at month 12 after implantation, defined as an improvement of at least 0.2 logMAR (≥10 letters).
Thirty-two patients completed the 12-month follow-up. Twenty-six (81%) of these achieved clinically significant visual acuity improvement, with a mean improvement of 0.49 logMAR (24.5 letters). All adverse events were related to the implantation procedure or both the implantation procedure and the device (none to the device alone). Twenty-six serious adverse events occurred in 19 patients; 4 events were classified as severe, including full-thickness macular hole, ocular hypertension, retinal detachment, and proliferative vitreoretinopathy. Eyes with implants (study eyes) experienced a larger 12-month increase in the area of atrophy than did nonstudy eyes (8.5 mm² vs 2.5 mm², respectively), which investigators attributed to the subretinal surgery.
This study is relatively small and has a short follow-up period. Ongoing monitoring for continued atrophy is needed to verify whether there is an impact on longer-term visual outcomes.
This is an exciting step forward in subretinal photovoltaic devices to restore vision, with substantially better reported visual acuity outcomes than previous epiretinal (e.g., Argus II) and subretinal (e.g., Alpha IMS) implant systems.^1–3 Further research is needed to determine whether this device will be a viable option for patients with advanced GA.
Financial Disclosures: Dr. Ajay Kuriyan discloses financial relationships with 4DMT, Adverum, Annexon, National Eye Institute, Novartis, Alcon Pharmaceuticals (Grant Support); Alimera Sciences, Allergan, Bausch and Lomb, EyePoint Pharmaceuticals (Consultant/Advisor); Iveric Bio, Optos (Lecture Fees/Speakers Bureau); Lumata Health, Recens Medical (Consultant/Advisor, Private Equity/Stock Holder); Spark Therapeutics (Consultant/Advisor, Lecture Fees/Speakers Bureau); Genentech (Consultant/Advisor, Lecture Fees/Speakers Bureau, Grant Support).
References:
1 da Cruz L et al. Ophthalmology. 2016;123(10):2248-2254.
2 Schaffrath K et al. JAMA Ophthalmology. 2019;137(8):896-902.
3 Stingl K et al. Front Neurosci. 2017;11:445.
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