SparingVision Completes Dosing in Phase I/II PRODYGY Trial of Gene-Agnostic AAV Gene Therapy for Retinitis Pigmentosa

PARIS, Feb. 9, 2026 — SparingVision, a clinical-stage genomic medicine company focused on retinal diseases, announced the successful completion of patient dosing in its Phase I/II PRODYGY clinical trial evaluating SPVN06, a novel adeno-associated virus (AAV)–based, gene-agnostic gene therapy for retinitis pigmentosa (RP). All patients dosed with the AAV gene therapy continue to demonstrate a favorable safety profile, with an initial data readout expected in 2027.

A total of 33 patients were enrolled in the PRODYGY study, including 27 patients who received a single administration of the AAV therapy SPVN06 since April 2023 and six patients randomized to an untreated control group. The trial is designed to evaluate the safety and exploratory efficacy of this AAV-mediated therapeutic approach, with endpoints spanning functional vision, retinal anatomy, and patient-reported quality of life.

SPVN06 is SparingVision’s first AAV-based gene therapy platform and is differentiated by its gene-agnostic AAV strategy. Unlike mutation-specific AAV gene therapies, SPVN06 uses an AAV vector to deliver a neuroprotective construct aimed at preserving cone photoreceptors, the retinal cells responsible for visual acuity and color vision. By targeting cone metabolism through an AAV-driven mechanism, the therapy has the potential to slow or halt disease progression regardless of the underlying genetic mutation.

The PRODYGY trial includes an initial dose-escalation phase in which nine patients received one of three escalating doses of the AAV gene therapy, followed by a randomized phase enrolling 24 patients into high-dose, medium-dose, and untreated control arms. Primary endpoint analysis will occur after all participants have completed at least one year of follow-up, providing a comprehensive assessment of AAV safety, tolerability, and early efficacy signals.

In parallel with clinical development, SparingVision is leveraging data from two large proprietary natural history studies and applying AI-powered machine learning tools to better contextualize outcomes observed with the AAV treatment. These analyses are intended to support regulatory discussions, optimize endpoint selection, and guide the design of a future registrational study for the AAV-based program.

Beyond retinitis pigmentosa, SPVN06’s AAV gene therapy approach may have broad applicability across multiple retinal diseases characterized by cone photoreceptor loss. Potential indications include other inherited retinal diseases (IRDs) as well as non-inherited conditions such as age-related macular degeneration, where AAV-mediated neuroprotection could help preserve remaining vision.

SparingVision plans to begin sharing data from the PRODYGY study with regulators in 2026, with the goal of initiating a pivotal AAV gene therapy trial in 2027.