Fig. 6: Ocular inflammation in NHPs following SPVN06 subretinal bilateral injection.

Ocular inflammation in vitreous and aqueous cells in (A) GLP low-dose study and (B) GLP high-dose study. Ocular inflammation in individual animals was assessed before SPVN06 injection and up to Week 13 post-injection, using comparable standard grading systems for the number of cells observed in the field, based on the SPOTS system [25]. In the GLP low-dose study (A), a grading system that differentiated between aqueous and vitreous cells at the lower grades was used, with the following classifications: 0 (aqueous: 0, vitreous: ≤1 cell observed), 0.5 (aqueous: 1–5, vitreous: 2–5 cells observed), 1 (6–15 cells observed), 2 (16–25 cells observed), 3 (26–50 cells observed), and 4 ( > 50 cells observed). In the GLP high-dose study (B), the classification was the same for aqueous and vitreous cells, with grades defined as follows: 0 (0–5 cells observed), 1 (6–25 cells observed), 2 (26–50 cells observed), 3 (51–100 cells observed), and 4 ( > 100 cells observed). Each point represents the maximal grade from both eyes of an individual animal (N ≥ 6 in each dosing group). Total anti-AAV antibody serum titers before SPVN06 injection and up to Week 13 post-injection in (C) GLP low-dose study and (D) GLP high-dose study. Data shown are mean ± SEM (N = 6 animals per dose). AAV adeno-associated virus, GLP Good Laboratory Practices, NHP non-human primate, SPOTs Semiquantitative Preclinical Ocular Toxicology Scoring System. # vehicle control for 1.0 and 2.0 x 10¹¹ vg/eye, ## vehicle control for 3.0 x 10¹¹ vg/eye.