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AIFA ends HOLOCLAR registry monitoring from 31 October 2026

🇮🇹 AIFA · Mon 02 Nov 2026

Italy's medicines agency says monitoring of the HOLOCLAR registry stopped on 31 October for its authorised indication, with treatment of current patients continuing under existing registry rules.

The Italian Medicines Agency (AIFA) has told users of its monitoring registries that monitoring of the HOLOCLAR registry ended on 31 October 2026. The notice, published on 2 November by AIFA's Monitoring Registries Office, says the change follows the entry into force of Determina Pres/1423/2026. A notice of that determination appeared in the Gazzetta Ufficiale no. 253 of 30 October 2026.

The closure applies to the therapeutic indication in the notice: treatment of adults with moderate to severe limbal stem cell deficiency, in one or both eyes, caused by physical or chemical ocular burns. The notice defines severity by superficial corneal neovascularisation in at least two quadrants, involvement of the central cornea and severe impairment of visual acuity. It also notes that a biopsy needs at least 1–2 mm² of undamaged limbal tissue.

Patients already being treated are not affected. AIFA says their management guarantees that treatment continues as set out in the registry form until it is completed.

For closing out records, clinicians can complete the end-of-treatment form by choosing "Chiusura Monitoraggio" among the reasons for ending treatment. They must pick a date, using the calendar tool, that is the same as or later than the monitoring end date.

The determination linked on the AIFA page is labelled Pres/123/2026, while the notice text cites Pres/1423/2026, so users should check the numbering against the published document. AIFA also lists a separate notice of the same date on closing the Managed Entry Agreements (MEA) for the HOLOCLAR registry. Its content was not included in the text reviewed here.

What it means for your team

  • Prescribing centres should use the "Chiusura Monitoraggio" end-of-treatment option, with a date on or after 31/10/2026, when closing records.
  • Treatment of patients already on HOLOCLAR continues under the terms in the registry form until treatment ends.
  • Marketing authorisation holders and market-access teams should read the separate AIFA notice on closing the MEA for the HOLOCLAR registry, and confirm the determination number against the published PDF.

Official source: AIFA ↗

Article written by VigiEye from the official source (AIFA). AI-assisted; check the source before acting.

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