Phase 3, Randomized Study Comparing Intracameral Bimatoprost Implant 15 µg and Selective Laser Trabeculectomy in Patients with Open-Angle Glaucoma or Ocular Hypertension

Figures & data

Table 1 Baseline Demographics Overall and by Assigned Treatment in Primary Eye (ITT Population)

Parameter	All Patients (N=144)	Primary Eye
		Bimatoprost Implant 15 µg (N=72)	SLT (N=72)
Age, mean (SD), y	60.0 (11.0)	62.1 (11.4)	57.9 (10.2)
<45, n (%)	14 (9.7)	6 (8.3)	8 (11.1)
45–65, n (%)	84 (58.3)	36 (50.0)	48 (66.7)
>65, n (%)	46 (31.9)	30 (41.7)	16 (22.2)
Sex, n (%)
Female	67 (46.5)	39 (54.2)	28 (38.9)
Male	77 (53.5)	33 (45.8)	44 (61.1)
Race, n (%)
Asian	8 (5.6)	3 (4.2)	5 (6.9)
Black or African American	21 (14.6)	9 (12.5)	12 (16.7)
White	112 (77.8)	59 (81.9)	53 (73.6)
Not reported	3 (2.1)	1 (1.4)	2 (2.8)
Ethnicity
Hispanic	18 (12.5)	7 (9.7)	11 (15.3)
Non-Hispanic	125 (86.8)	64 (88.9)	61 (84.7)
Not reported	1 (0.7)	1 (1.4)	0

Abbreviations: ITT, intent-to-treat; SD, standard deviation; SLT, selective laser trabeculoplasty.

Table 2 Baseline Characteristics of Eyes (Primary and Contralateral) by Study Treatment (ITT Population)

	Bimatoprost Implant 15 µg (N=144 Eyes)	SLT (N=144 Eyes)
Diagnosis, n (%)
Ocular hypertension	28 (19.4)	27 (18.8)
Open-angle glaucoma	116 (80.6)	117 (81.3)
Primary open-angle glaucoma	114 (79.2)	115 (79.9)
Pseudoexfoliative glaucoma	1 (0.7)	1 (0.7)
Pigmentary glaucoma	1 (0.7)	1 (0.7)
IOP, mean (SD), mm Hg	24.37 (2.45)	24.40 (2.72)
≤25 mm Hg, n (%)	99 (68.8)	105 (72.9)
>25 mm Hg, n (%)	45 (31.3)	39 (27.1)
Lens status, n (%)
Phakic	125 (86.8)	124 (86.1)
Pseudophakic	19 (13.2)	20 (13.9)
Required washout of previous topical IOP-lowering medication, n (%)	128 (88.9)	131 (91.0)
CECD, mean (SD), cells/mm^2	2488.8 (325.1)	2489.9 (310.1)

Abbreviations: CECD, central corneal endothelial cell density; IOP, intraocular pressure; ITT, intent-to-treat; SD, standard deviation; SLT, selective laser trabeculoplasty.

Figure 1 Change in IOP from baseline in bimatoprost implant– and SLT-treated eyes. Data shown are least-squares means ± standard errors from a mixed-effects model for repeated measures. P values are for comparison of bimatoprost implant versus SLT.

Abbreviations: IOP, intraocular pressure; SLT, selective laser trabeculoplasty.

Figure 2 Kaplan−Meier analysis of time to first use of nonstudy (rescue) IOP-lowering treatment.

Abbreviations: IOP, intraocular pressure; SLT, selective laser trabeculoplasty.

Figure 3 Proportion of eyes achieving at least a 20% decrease in IOP from baseline. Proportions were calculated using observed data for all eyes with IOP data available at baseline and the indicated visit.

Abbreviations: IOP, intraocular pressure; SLT, selective laser trabeculoplasty.

Table 3 Incidence of Ocular TEAEs (Safety Population)

TEAE, No. of Eyes (%)	Bimatoprost Implant 15 µg (N=141 Eyes)	SLT (N=141 Eyes)
Conjunctival hyperemia	47 (33.3)	28 (19.9)
Corneal endothelial cell loss	18 (12.8)	2 (1.4)
Punctate keratitis	18 (12.8)	14 (9.9)
Intraocular pressure increased	16 (11.3)	14 (9.9)
Corneal edema	14 (9.9)	2 (1.4)
Conjunctival hemorrhage	12 (8.5)	3 (2.1)
Photophobia	10 (7.1)	4 (2.8)
Eye irritation	9 (6.4)	6 (4.3)
Eye pain	9 (6.4)	7 (5.0)
Dry eye	7 (5.0)	5 (3.5)
Foreign body sensation	7 (5.0)	1 (0.7)
Anterior chamber cell	6 (4.3)	2 (1.4)
Conjunctivitis	5 (3.5)	1 (0.7)
Cataract	4 (2.8)	1 (0.7)
Blepharitis	3 (2.1)	3 (2.1)
Corneal dystrophy	3 (2.1)	2 (1.4)
Conjunctival edema	3 (2.1)	1 (0.7)
Corneal opacity	3 (2.1)	1 (0.7)
Hordeolum	3 (2.1)	0
Iris adhesions	3 (2.1)	2 (1.4)
Iritis	3 (2.1)	0
Vision blurred	3 (2.1)	1 (0.7)

Notes: All adverse events reported in at least 2% of eyes treated with bimatoprost implant 15 µg or SLT are listed.

Abbreviations: SLT, selective laser trabeculoplasty; TEAE, treatment-emergent adverse event.

Table 4 Corneal Endothelial Cell Density Findings on Specular Microscopy (Safety Population)

Parameter (SD), Cells/mm^2	Bimatoprost Implant (N= 141 Eyes)	SLT (N=141 Eyes)
Mean CECD at baseline	2487 (324) [n=141]	2487 (311) [n=141]
Mean change in CECD from baseline
Week 4
After 1 implant administration	+0.1 (64.4) [n=139]	−53.5 (142.1) [n=137]
Week 12
After 1 implant administration	−17.1 (74.0) [n=137]	−55.8 (133.9) [n=136]
Week 24
After 1 implant administration	−62.8 (285.1) [n=11]	−25.0 (76.9) [n=10]
After 2 implant administrations	−62.1 (154.3) [n=122]	−60.0 (136.6) [n=122]
Week 40
After 1 implant administration	−146.9 (431.1) [n=10]	−24.7 (83.6) [n=9]
After 2 implant administrations	−158.3 (342.9) [n=82]	−75.9 (128.3) [n=82]
After 3 implant administrations	−144.7 (348.4) [n=32]	−40.3 (102.9) [n=32]
Week 52
After 1 implant administration	−140.8 (423.3) [n=10]	−36.6 (55.5) [n=9]
After 2 implant administrations	−233.8 (448.0) [n=90]	−68.1 (119.0) [n=89]
After 3 implant administrations	−202.9 (381.1) [n=33]	−49.4 (118.6) [n=33]

Notes: The analysis evaluated CECD change from baseline by the number of bimatoprost implant administrations that had been received in the primary or contralateral eye.

Abbreviations: CECD, corneal endothelial cell density; SD, standard deviation; SLT, selective laser trabeculoplasty.