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Article History

Received: 7 January 2025

Revised: 10 July 2025

Accepted: 21 July 2025

First Online: 4 August 2025

Competing interests

: MM, LC, ASG, HK, FL are employees of SparingVision. RF is an employee of EyeCRO. KM is an employee of SNBL. VS is an employee of Charles River Laboratories. TL received research support from SparingVision and was a consultant for SparingVision. JAS and TL are cofounders of SparingVision. TL and JAS are shareholders of SparingVision related to PCT applications PCT/EP2016/061488 and PCT/EP2018/086744. MM, ASG, HK, TL, JAS, FL have personal financial interest in SparingVision.

: All experiments were performed in accordance with relevant guidelines and regulations. Studies in rd10/rd10 mice were conducted at the EyeCRO animal facility (accredited by the American Association for Accreditation of Laboratory Animal Care [AAALAC] International). All experimental procedures adhered to the Association for Research in Vision and Ophthalmology [ARVO] Statement for the Use of Animals in Ophthalmic and Vision Research and were approved by the EyeCRO Institutional Animal Care and Use Committee (approval number SOW003 IACUC #2019-01-17-002). Data from a separate study conducted at the same facility in naïve wild-type (WT) mice were included to serve as an additional reference point (approval number SOW001 IACUC #2019-01-17-002). Three studies were conducted in NHPs: one 4-week pilot study, and two 13-week Good Laboratory Practice (GLP) studies: a high-dose study and a low-dose study, each involving multiple doses. All three studies were conducted with cynomolgus macaques (Macaca fascicularis). The 4-week pilot study and GLP high-dose study were conducted at the Charles River Laboratories in Mattawan, USA (CR-MWN), where protocols were reviewed and approved by the CR-MWN Institutional Animal Care and Use Committee (IACUC, ethical body) in accordance with the guidelines of the US National Research Council (approval numbers: 3228-001 for the pilot study and 3228-002 for the GLP high-dose study). A second GLP study using lower doses of SPVN06 (GLP low-dose study) was conducted subsequently at Shin Nippon Biomedical Laboratories, Ltd (SNBL) in Kagoshima, Japan. The protocol for this study was reviewed and approved by SNBL IACUC (approval number IACUC563-001) and Recombinant Gene Experiment Safety Committee (approval number LMOD-563001), and was conducted in compliance with the animal welfare regulations of SNBL, which is accredited by AAALAC International.