Drugs / SPVN06
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT05748873 | Apr 2023 → Feb 2027 expected | retinitis pigmentosa | SparingVision | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 20
| Date | Issuer | Release |
|---|---|---|
| 2025-10-09 | SparingVision | Results SparingVision Highlights Advances in Gene-Agnostic Gene Therapies at ESGCT 2025 sparingvision.com ↗
Results show that SPVN06 continues to demonstrate a favorable safety profile up to 18 months post-treatment, with no serious adverse events, no dose-limiting toxicities, and no discontinuations. |
| 2025-05-19 | SparingVision | Results SparingVision Presents PRODYGY data and Research Update in Two Oral Presentations at ASGCT 2025 sparingvision.com ↗
Nine patients with severe advanced RP treated in Phase I with increasing doses of SPVN06 continue to show a favorable safety profile up to 1.5 years after dosing. |
| 2025-05-06 | SparingVision | Results SparingVision Announces Favorable Safety Update from PRODYGY Trial at ARVO 2025 sparingvision.com ↗
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. |
| 2025-04-22 | SparingVision | Regulatory SparingVision Receives FDA Support to Initiate Phase II trial of SPVN06 in Geographic Atrophy Secondary to Dry-AMD sparingvision.com ↗ |
| 2025-02-13 | SparingVision | Results SparingVision Announces Presentation of SPVN06 Safety Data at the Macula Society 48th Annual Meeting sparingvision.com ↗
Results showed new, comprehensive safety data across all three dose-escalation cohorts, representing the most complete analysis of SPVN06 safety to date. |
| 2025-01-21 | SparingVision | Results SparingVision advances PRODYGY trial into Phase II following positive DSMB recommendation sparingvision.com ↗
Safety data from the third and final cohort of Step 1, injected with high-dose SPVN06, demonstrated favorable tolerability. |
| 2024-10-24 | SparingVision | Results SparingVision Presents Updates on PRODYGY Trial and PHENOROD2 Study at ESGCT 2024 sparingvision.com ↗
These data, previously announced in September 2024, show that SPVN06 demonstrates a favorable safety profile at 12 months for the low dose cohort and 6 months for the medium dose cohort in the PRODYGY Phase I/II trial. |
| 2024-09-23 | SparingVision | Results SparingVision Reports Progress on SPVN06 at Major Ophthalmology Conferences sparingvision.com ↗
The data, which includes 12-month safety results for the low dose cohort and 6-month safety results for the medium dose cohort, demonstrates a continued favorable safety profile. |
| 2024-05-13 | SparingVision | Results SparingVision Presents One Year Results from the PHENOROD2 Natural History Study and Preliminary SPVN06 Safety Data at Key Congresses sparingvision.com ↗
In addition, the Company presented initial one-month and six-month safety data from the Phase I/II PRODYGY clinical trial of its lead gene-agnostic investigational gene therapy, SPVN06 demonstrating a favorable safety profile. |
| 2024-02-08 | SparingVision | Results SparingVision Presents Initial SPVN06 Safety Data at the Macula Society 47th Annual Meeting sparingvision.com ↗
Initial six-month data on the three patients who received a low dose of SPVN06 showed no serious adverse events, significant inflammation, discontinuation, or dose-limiting toxicity. |
| 2024-01-24 | SparingVision | Results SparingVision Reaches Final Dose Escalation Step in PRODYGY Trial with SPVN06 for retinitis pigmentosa sparingvision.com ↗
The trial has now progressed to the final dose cohort of the dose-escalation phase (Part 1). |
| 2023-08-30 | SparingVision | Results SparingVision Reports Positive Initial Safety Data from the first cohort treated in its PRODYGY Phase I/II Gene Therapy Trial sparingvision.com ↗
Safety data collected on the first three patients (cohort 1) treated with a low dose showed that SPVN06 has been well tolerated with a favorable safety profile. |
| 2023-04-27 | SparingVision | Results SparingVision Presents Progress of its Lead Gene Therapy Program SPVN06 at ARVO 2023 sparingvision.com ↗
The data demonstrated the absorption and shedding of SPVN06, which was transiently observed in blood and tears, and high tropism for the retina). |
| 2022-12-01 | SparingVision | Regulatory SparingVision’s lead asset SPVN06 clears IND application in the US for the treatment of retinitis pigmentosa sparingvision.com ↗
SparingVision has also submitted a clinical trial authorisation (CTA) application to the French regulator (ANSM), which is currently under review. |
| 2022-10-13 | SparingVision | Results SparingVision Presents Validating Data of its Lead Gene Therapy Programs, SPVN06 and SPVN20, at ESGCT 2022 sparingvision.com ↗
Following subretinal administration of SPVN06, encoding the short and long forms of the rod-derived cone viability factor (RdCVF/RdCVFL), highly significant slowing-down of visual acuity loss in the treated animals compared to controls was observed. |
| 2022-05-19 | SparingVision | Results SparingVision Presents Additional Data on its Breakthrough Gene Therapy Approach SPVN06 at ASGCT 2022 sparingvision.com ↗
Data from the 1-month pilot tolerability and biodistribution study in non-human primates show that SparingVision’s gene independent program SPVN06 is well tolerated. |
| 2022-05-05 | SparingVision | Results SparingVision Presents Progress of its Lead Gene Therapy Program, SPVN06, at ARVO 2022 sparingvision.com ↗
SparingVision first presented pharmacology data on SPVN06, a breakthrough gene therapy approach targeting Inherited Retinal Diseases (IRDs), demonstrating a highly significant protection of visual function as well as greater cone density following subretinal administration of SPVN06 in a murine model. |
| 2021-05-11 | SparingVision | Results SparingVision to Present at the American Society of Gene and Cell Therapy (ASGCT) 24th Annual Meeting sparingvision.com ↗
The administration of the AAV SPVN06 therapy was found to preserve cone morphology as well as preserve m-opsin expression in cone segments. |
| 2021-05-06 | SparingVision | Results SparingVision Presents Three Posters at the Association for Research in Vision and Ophthalmology (ARVO) 2021 Annual Meeting sparingvision.com ↗
The administration of the AAV SPVN06 therapy was found to preserve cone morphology as well as preserve m-opsin expression in cone segments. |
| 2020-06-30 | SparingVision | Regulatory SparingVision Receives European Orphan Designation for its Drug Candidate SPVN06 Dedicated to Inherited Retinal Dystrophies sparingvision.com ↗
SparingVision, a biotechnology company specializing in the research and development of innovative therapies for treatment of hereditary retinal degenerative diseases such as retinitis pigmentosa, announces today the decision of the European Commission to grant Orphan Drug Designation for SPVN06 for the treatment of inherited retinal dystrophies. |
All press releases naming this drug 25 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SPVN06 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05748873 ↗ |
| Modality | Gene therapy (AAV / viral vector) | “SPVN06 is an adeno-associated virus (AAV)-based gene- and mutation-agnostic investigational therapy” PMID 40759732 ↗ Aug 2025 |
| Route | Other | “single subretinal administration” NCT05748873 ↗ |