Alpha Genesis has established comprehensive NHP models for ocular safety and gene therapy evaluation, uniquely designed to replicate human pathophysiology and provide regulatory-grade evidence for translational development. Our platforms support delivery via subretinal, intravitreal, and suprachoroidal routes, using highly controlled and validated techniques that ensure consistent dosing, vector targeting, and subject safety. Therapeutic assessment includes multiparametric evaluation of vector tropism, transgene expression, dose-ranging responses, and persistence, all monitored with advanced imaging modalities, longitudinal electrophysiology, and molecular biomarker profiling. Safety endpoints encompass neutralizing antibody detection, adaptive and innate immune profiling, inflammatory cytokine cascades, and comprehensive ocular histopathology, allowing for early detection of adverse responses and precise characterization of tolerability. Efficacy assessments span acute to chronic phases, incorporating structural preservation analysis, functional rescue measures, and immune modulation data to demonstrate therapeutic durability.

 

By combining GLP-compliant study execution with adherence to AAALAC, USDA, OLAW, and FDA regulatory frameworks, we deliver reproducible, regulatory-ready datasets tailored for IND submissions and global health authority review. Our dedicated scientific teams and specialized veterinary ophthalmologists ensure that studies achieve the highest standards of accuracy, reproducibility, and ethical care, providing sponsors with the translational confidence needed to advance ocular gene therapy programs efficiently and responsibly from preclinical discovery to clinical application.