News

February, 09 2026 • Articles

SparingVision Successfully Completes PRODYGY Trial Patient Dosing with SPVN06, its Novel Neuroprotective Gene Therapy

• All patients dosed with SPVN06 in Phase I/II trial continue to demonstrate a favorable safety profile
• Initial data readout for this novel gene-agnostic therapy expected in 2027

Paris, February 9, 2026 - SparingVision (“the Company”), a clinical-stage genomic medicine company transforming the treatment of retinal diseases, today announced that it has successfully completed dosing in its Phase I/II PRODYGY clinical trial evaluating the company’s novel gene-agnostic therapy SPVN06 for the treatment of retinitis pigmentosa (RP). A total of 33 patients were enrolled in PRODYGY, including 27 patients dosed with SPVN06 since April 2023 and six randomized in a control group. Initial data readout is expected in 2027.

Dr. Kali Stasi, Chief Medical Officer of SparingVision, commented: “This is an important milestone in our goal to transform the treatment landscape for patients with RP. By sustaining the natural function of photoreceptors, SPVN06 has the unique potential to preserve visual acuity and color vision in degenerative retinal diseases such as RP, regardless of genetic mutation or cause of the disease. This could potentially benefit patients from diagnosis until cone photoreceptors remain functional. The successful completion of dosing with SPNV06, with a continued favorable safety profile, reinforces our confidence in our unique approach. I would like to thank all participating patients, investigators, and clinical sites. Dedication and partnership are essential in bringing this novel therapy to patients who need it.”

SPVN06 is SparingVision’s first AAV-based gene therapy designed to preserve vision in patients with degenerative retinal diseases. Unlike gene-specific therapies, SPVN06 takes a gene-agnostic approach that protects cone photoreceptors – the light-sensing cells responsible for visual acuity and color vision – by slowing or stopping their degeneration through neuroprotective effects on cone metabolism.

The therapy has potential applications across multiple retinal conditions where cone photoreceptor loss leads to blindness, including inherited retinal diseases (IRDs) such as RP, as well as non-inherited conditions like age-related macular degeneration (AMD).

Leveraging data collected from two large scale proprietary natural history studies, SparingVision is using cutting-edge AI-powered machine learning tools in parallel with statistical analyses, to generate a comprehensive understanding of data from the PRODYGY study. These will help identify emerging efficacy signals and inform the selection of optimal endpoints and patient populations for a registrational study. SparingVision intends to start sharing data with regulators in 2026, with the aim to initiate a pivotal trial in 2027.

PRODYGY trial overview:

• The trial is designed to assess safety and exploratory efficacy endpoints, including functional, anatomical and quality of life endpoints.
• In the dose-escalation part of the study (Step 1), nine (9) patients were injected across three doses of SPVN06.
• In the second part of the study (Step 2), twenty-four (24) patients were randomized into three study arms: high dose (n=9), medium dose (n=9), or an untreated control group (n=6) of SPVN06.

Primary endpoint analysis will occur after all patients have completed at least one year of follow-up, with initial data readout expected in 2027.

This news follows the presentation of preliminary safety data from the PRODYGY trial at ARVO 2025 in May 2025.

**ENDS**

 

Contacts:

SparingVision
Stéphane Boissel	President & CEO investor@sparingvision.com
ICR Healthcare
Amber Fennell, Namrata Taak, Davide Salvi	sparingvision@icrhealthcare.com