. 2024 Nov 22;5(2):100657. doi: 10.1016/j.xops.2024.100657

Table 3.

Model-Predicted First Dose and Steady-State Exposure Metrics in Serum and Vitreous Humor

Pegcetacoplan Dose Regimen	Summary Statistic	First Dose					Steady-State					AR
Pegcetacoplan Dose Regimen	Summary Statistic	C_max, μg/mL	C_min, μg/mL	C_avg, μg/mL	AUC_τ, μg/mL· day	T_max, Days	C_max, μg/mL	C_min, μg/mL	C_avg, μg/mL	AUC_τ, μg/mL· day	T_max, Days	AR
Serum exposure
15 mg monthly	Median	1.60	0.200	1.20	35.9	10.5	2.20	1.10	1.80	52.8	8.50	1.50
	5th, 9th percentile	0.900, 2.10	0.100, 0.300	0.700, 1.70	21.4, 49.6	7.50, 13.5	1.40, 3.00	0.500, 1.70	1.10, 2.50	32.4, 74.4	6.50, 9.50	1.20, 1.80
	Geometric mean	1.50	0.200	1.10	34.3	10.4	2.20	1.00	1.70	50.8	8.20	1.50
	Geometric % CV	29.1	26.2	30.1	30.1	20.9	25.9	43.9	30.6	30.6	14.2	14.5
15 mg every other month	Median	1.50	0.100	0.800	48.5	10.2	1.70	0.200	0.900	52.6	10.0	1.10
	5th, 9th percentile	0.600, 2.10	0.100, 0.200	0.300, 1.10	16.5, 65.3	6.00, 14.0	0.700, 2.20	0.100, 0.400	0.300, 1.20	17.9, 71.1	5.70, 12.5	1.00, 1.30
	Geometric mean	1.40	0.100	0.700	42.2	9.80	1.50	0.200	0.800	46.2	9.40	1.10
	Geometric % CV	53.4	47.1	50.9	50.9	26.2	46.1	70.5	46.0	46.0	24.7	8.35
Vitreous exposure
15 mg monthly	Median	4523	794	1917	57 495	_	4724	974	2375	71 245	_	1.20
	5th, 9th percentile	4129, 5037	394, 1310	1503, 2335	45 077, 70 035	_	4172, 5710	422, 1960	1637, 3507	49 106, 105 210	_	1.10, 1.50
	Geometric mean	4550	771	1908	57 228	_	4815	964	2409	72 266	_	1.30
	Geometric % CV	6.68	42.2	14.7	14.7	_	12.1	55.8	26.7	26.7	_	12.3
15 mg every other month	Median	3903	157	1139	68 353	_	3909	159	1171	70 275	_	1.00
	5th, 9th percentile	3792, 4452	43.2, 712	840, 1835	50 379, 110 103	_	3792, 4614	42.1, 864	833, 2239	49 997, 134 325	_	1.00, 1.20
	Geometric mean	3974	158	1166	69 985	_	4008	164	1229	73 758	_	1.10
	Geometric % CV	5.81	110	25.2	25.2	_	7.88	124	33.1	33.1	_	8.15

AR = accumulation ratio; AUCτ = area under the concentration-time curve for dosing interval τ; C_avg = average concentration; C_max = maximum concentration; C_min = minimum concentration; CV = coefficient of variation; T_max = time to maximum serum concentration.

N = 121 patients with geographic atrophy receiving pegcetacoplan 15 mg monthly and 110 patients with geographic atrophy receiving pegcetacoplan 15 mg every other month.