GLP-1 Ocular Safety Monitoring At Point-Of-Need

Regulators are sharpening their focus on ocular safety in GLP-1 receptor agonist trials following emerging evidence linking semaglutide to non-arteritic anterior ischemic optic neuropathy (NAION). The European Medicines Agency’s PRAC recently updated product labeling to list NAION as a “very rare” adverse effect. For sponsors, this signals a new era of heightened scrutiny around ocular endpoints.

To mitigate risk, proactive safety monitoring must go beyond standard protocol checklists. Comprehensive baseline and follow-up eye exams, real-time evaluation of vision changes, and meticulous audit-ready documentation are now critical to avoiding costly rework and regulatory setbacks. 20/20 Onsite enables sponsors to operationalize GLP-1 ocular safety monitoring with standardized ophthalmic assessments delivered directly at sites, near patients, or in community settings. Certified technicians and physicians follow study-specific SOPs using locked devices with daily calibration and centralized oversight. This approach ensures consistent, first-time-right data capture, live QC tracking, and continuously inspection-ready audit files.