Advisory Committee; Dermatologic and Ophthalmic Drugs Advisory Committee; Renewal

mbers agreed it is not necessary to continue to collect ``follow-up data'' (i.e., pregnancy and fetal outcome information) and that more effective communication and transparency are needed regarding how patients' data will be used if they participate in the iPLEDGE Pregnancy Registry. Impact: On February 6, 2026, the Agency approved modification to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) to minimize burden on patients, prescribers, and pharmacies while maintaining the use of isotretinoin. On January 9, 2023, the DODAC met to discuss supplemental biologics license application (sBLA) 125387, aflibercept solution for intravitreal injection, submitted by Regeneron Pharmaceuticals, Inc. The supplement was submitted in response to FDA's pediatric written request. FDA's written request was for studies of aflibercept in the treatment of retinopathy of prematurity. Two Discussion Questions were proposed to the panel: (1) Discuss how the studied use of aflibercept in the treatment of retinopathy of prematurity can best be communicated to physicians and the caregivers of these premature infants, and (2) how it should be labeled in a real-world setting. Regarding the first speaking point, the committee acknowledged the benefits of using anti- vascular endothelial growth factor (anti-VEGF) for the treatment of retinopathy of prematurity (ROP), which is evident by the data