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On 13th June 2025, the EPA received a notification from SparingVision, 5-7 avenue Percier, 75008 Paris, France, seeking consent under Article 14 of the GMO (Deliberate Release) Regulations, S.I. No 500 of 2003, to carry out the deliberate release of a Genetically Modified Organism (GMO).

Description of the GMO and purpose of the deliberate release

The GMO is SPVN20 or AAVi-GIRK1(F137S), a gene therapy product which will be administered to patients with no light perception (NLP) due to end-stage rod-cone dystrophy (RCD) and who retain dormant foveal cone photoreceptors.

 

The active substance of SPVN20 (AAVi-GIRK1(F137S)) consists of an adeno-associated virus (AAV) engineered vector capsid, encapsidating a transgene that encodes for a mutated form of the human GIRK1 (GIRK1(F137S)), a G-protein-gated inward rectifier potassium (K+) channel (GIRK). Following SPVN20 administration to patients with NLP due to end-stage RCD, GIRK1(F137S) expression in dormant cones could provide an alternative hyperpolarization mechanism in response to light stimulus, in the form of an alternative phototransduction cascade, allowing cone reactivation.

 

The primary objective of the clinical trial is to assess the safety and tolerability of a single intravitreal injection (ITV) of SPVN20 in subjects with NLV due to end-stage RCD, over a period of 6 months after administration.

Location and Duration

The clinical trial will take place at the following location between September 2025 and September 2031.

One Irish site, Royal Victoria Eye and Ear Hospital, Adelaide Road, Dublin 2, will participate in the clinical trial.

Legislation

Any person or organisation proposing to carry out a deliberate release of a GMO for purposes other than placing on the market (for example, the performance of trials) must comply with the legislative requirements set out under Part II of the GMO (Deliberate Release) Regulations S.I. No 500 of 2003.

Role of the EPA

In accordance with the Regulations, it is the role of the Agency to assess the risks posed by the proposed deliberate release to human health or the environment.
The Agency must respond to the applicant in writing within 90 days of receipt of the notification.  This does not include any period during which the Agency is awaiting a response to a request for further information. In its response to the applicant, the Agency may indicate that consent to the proposed deliberate release is:

  • Granted, with or without conditions, or
  • refused, and the reasons for the refusal.

In reaching its decision, the Agency will take into consideration the views expressed by:

  • the GMO Advisory Committee, a statutory body set up to advise the Agency on any aspect of its functions in relation to GMOs; and,
  • common application form for investigational medicinal products for human use that contain or consist of AAV vectors
  • members of the public in representations forwarded to the Agency in accordance with Article 16 of the Regulations (see also “How to make representations to the EPA about a proposed GM release”);
  • competent authorities of other Member State of the European Communities.
Newspaper notice

The applicant published a notice of the proposed deliberate release, in the Irish Independent (20th June 2025) inviting members of the public to make representations to the EPA within 28 days of publication of the notice in a newspaper (i.e. up to 5pm on 18th July 2025). 

 

GMO Register Entry

The proposed clinical trial has been assigned GMO Register No G0897-01. The Register provides significant details about the trial.  The register entry will be updated as further details become available.

Relevant Documentation

Summary Notification Information Format (SNIF) - B/IE/25/01
Common Application Form
Newspaper Advertisement
How to make representations to the EPA about a proposed release
GMO Register Entry G0897-01