GMO Register No: G0784-01

SNIF Notification No: B/IE/21/01

On 1^st December 2021, the EPA received a notification from Gyroscope Therapeutics Ltd., Rolling Stock Yard, 188 York Way, London N7 9AS, United Kingdom, 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 GT005, a gene therapy treatment which will be administered to patients suffering from the eye disease, geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

 GT005 is derived from wild-type adeno-associated viral vector serotype 2 (AAV2). It has been modified to deliver a gene called Complement Factor I (CFI) to cells in the eye. GT005 is not capable of replication.

 The patients will participate in two clinical trials. Both trials will use the same GMO at different doses. The purpose of the trials will be to test whether a single administration of GT005 is effective at slowing the progression of the disease and that it is safe.

 

Location and Duration

The clinical trials will take place at the following locations between January 2022-July 2026

• Whitfield Hospital Institute of Eye Surgery, 2 Butlerstown, Waterford, X91 DH9W (surgical and follow up site);

(Patient follow up will continue for a further 5 years after treatment).

 

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 and 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.

The notification documents are provided here below:

• Summary Notification Information Format (SNIF); 

 

GMO Register Entry

The proposed clinical trial has been assigned GMO Register No G0784-01. The Register provides significant details about the trial.  The register entry will be updated as further details become available.

Relevant Documentation

Common application form

Summary Notification Information Format (SNIF)

Newspaper Advert  

GMO Register Entry G0784-01

Minutes from Board meeting

Inspectors Report G0784-01

Consent Conditions G0784-01