Table 1.

Outline of the In Vivo Study Design

Study	Study Size,	Delivery	Injection Volume	Dose*	Study Duration	PK Timepoints
Number	Species	Route	(Concentration)	(mg/Eye)	(Weeks)	After the Dose
1	n = 10 male NZW rabbits	IVT SC	0.025 mL (4 mg/mL) 0.1 mL (10 mg/mL)	1 1	1	0.08, 6, 24, 72, and 168 hours
2	n = 14 male DB rabbits	SC	0.1 mL (40 mg/mL)	4	13	2, 4, 8, 15, 29, 61, and 91days
3	n = 14 male DB rabbits	SC	0.1 mL (1 mg/mL) 0.1 mL (0.3 mg/mL)	0.1 0.03	10	2, 8, 15, 31, 45, 61, and 66 (±1) days

NZW, New Zealand White; DB, Dutch Belted.

^*Both eyes of each animal were dosed. All animals were free of ophthalmologic abnormalities before test article administration, assessed by a board-certified veterinary ophthalmologist using a slit lamp biomicroscope and an indirect ophthalmoscope.