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SparingVision Announces Favorable Safety Update from PRODYGY Trial at ARVO 2025

SparingVision Announces Favorable Safety Update from PRODYGY Trial at ARVO 2025

 

  • Preliminary safety data from the first two sentinel patients enrolled in Phase II show a favorable safety profile up to one month after first administration
  • SPVN06 continues to demonstrate a favorable safety profile up to 1.5 years in Phase I

Paris, 6 May 2025 – SparingVision (“the Company”), a clinical-stage genomic medicine company transforming the treatment of retinal disease, announces that Professor Isabelle Audo, one of the Principal Investigators of the PRODYGY Phase I/II clinical trial, has presented the latest safety data showing the continued favorable safety profile of SparingVision’s lead candidate, SPVN06, in a poster at the 2025 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) taking place from 4-8 May in Salt Lake City, USA.

Prof. Audo’s presentation shared updated safety data from Step 1 of PRODYGY (Phase I), confirming that patients with severe advanced retinitis pigmentosa (RP), treated with increasing doses of SPVN06, continue to show a favorable safety profile up to 1.5 years after dosing. No significant intraocular inflammation or immune response was observed, and no serious adverse events, dose-limiting toxicities, or discontinuations were reported, reinforcing the long-term tolerability of SPVN06.

The data also included preliminary safety findings from Step 2 of PRODYGY (Phase II), which is currently ongoing in patients with intermediate advanced RP. Preliminary safety data from the first two sentinel patients enrolled in Phase II showed a favorable safety profile through one month after subretinal injection. The independent Data Safety Monitoring Board (DSMB) reviewing the safety data of the two sentinel patients of Step 2 supported the continuation of the trial as planned.

Professor Isabelle Audo, Principal Investigator, commented: “The updated safety data from the PRODYGY Phase I/II trial reinforce the potential of SPVN06 as a well-tolerated, gene-agnostic approach for patients with RP, one of the leading inherited causes of blindness globally. We are encouraged by the sustained safety profile of SPVN06 seen in the PRODYGY Phase I/II trial. Patients affected with RP are in dire need of treatment options, especially gene-agnostic ones, and we look forward to the progress of the PRODYGY trial.”

Initiated in 2025, the Phase II of PRODYGY (Step 2) is a controlled, randomized extension conducted in 24 patients across three arms: high dose (n=9), medium dose (n=9) and one control arm of uninjected patients (n=6). The Phase II focuses on patients with intermediate advanced RP, specifically those with visual acuity between 20/200 and 20/40 and a visual field of at most 20 degrees.

Safety summary in Study Eyes from Phase I:

  • 11 AEs deemed related to SPVN06 by the Principal Investigator, including transient mild intraocular pressure elevation, decrease in visual acuity, and mild anterior uveitis.
  • 24 AEs deemed procedure-related by the Principal Investigator, including a macular hole that resolved spontaneously, secondary cataract, intraocular lens luxation, decrease in visual acuity, and hyperreflective subretinal deposits.

**ENDS**

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NOTES TO EDITORS

Contacts:

Investors: Nathalie Trepo (nathalie.trepo@sparingvision.com)

Media: ICR Healthcare (sparingvision@icrhealthcare.com)

About SparingVision

SparingVision is a clinical-stage genomic medicines company with a mission to translate pioneering science into vision saving treatments. Leveraging its unparalleled understanding of retinal diseases, SparingVision has built the world’s most compelling portfolio of synergistic cutting-edge gene therapy and genome editing treatments for blinding retinal diseases. Its most advanced products, SPVN06 and SPVN20 look to go beyond single gene correction therapies to deliver new mutation agnostic treatments for Retinitis Pigmentosa (RP) and geographic atrophy secondary to dry-AMD, two leading causes of blindness globally. The Company also has a strategic collaboration with Intellia Therapeutics (NASDAQ:NTLA) to develop novel genome editing-based treatments for ocular disease utilizing CRISPR-Cas9 technology.

SparingVision is a spin-off from the Paris Vision Institute and backed by high-quality investors including 4BIO Capital, Adbio Partners, Bpifrance, Retinal Degeneration Fund, the venture arm of the Foundation Fighting Blindness, Fondation Voir & Entendre, Intellia Therapeutics, UPMC Enterprises, Jeito Capital and Ysios Capital.

Visit www.sparingvision.com for more and follow us on LinkedIn and X  @SparingVision

 

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