A Risk Evaluation and Mitigation Strategy (REMS) is not proposed as the risks associated with LUXTURNA can be managed through routine measures. The proposed risk management plan includes:
1. Pharmacovigilance Plan: Routine and enhanced pharmacovigilance to monitor for known risks (e.g., endophthalmitis, cataract, increased IOP) and unexpected adverse events.
2. Risk Minimization Activities:
   a. Prescribing Information: The PI will communicate the risks associated with the subretinal administration procedure and LUXTURNA to healthcare providers.
   b. Surgical Training Program: Spark Therapeutics will implement a mandatory training program for surgeons on the proper preparation and subretinal administration of LUXTURNA to mitigate procedural risks.
   c. Pharmacy/Handling Training: Informational materials will be provided to hospital pharmacies regarding the specific storage, handling, and preparation requirements for a gene therapy product.