First Real-World, Multicenter, Post-Marketing, Retrospective Study of Dexamethasone Intraocular Suspension for Inflammation After Cataract Surgery

Figures & data

Table 1 Demographic Characteristics

Characteristic	All Patients (N=527)
Age at Surgery (years)
Mean (SD)	71.5 (8.35)
Sex
Female	308 (58.4%)
Male	219 (41.6%)
Ethnicity
Hispanic or Latino	74 (14.0%)
Not Hispanic or Latino	327 (62.0%)
Not Reported	100 (19.0%)
Unknown	26 (4.9%)
Race
American Indian or Alaska Native	0
Asian	8 (1.5%)
Black or African American	35 (6.6%)
Native Hawaiian or Other Pacific Islander	1 (0.2%)
White	388 (73.6%)
Other	8 (1.5%)
Not Reported	73 (13.9%)
Unknown	14 (2.7%)

Figure 1 Anterior chamber cell clearing (ACC grade 0) among eyes with recorded grading at postoperative days 1, 8, 14, and 30, for all eyes undergoing surgery (A) and eyes with glaucoma (B). n at each POD represents number of eyes with recorded results.

Figure 2 Anterior chamber cell (ACC) grading for PODs 1, 8, 14, and 30 by concomitant medication. Intraocular DXM and intracameral phenylephrine/ketorolac group may also have received topical steroid and/or NSAID.

Table 2 Visual Acuity at Postoperative Day 30

Test	Outcome	Eyes with Surgery (n)	Eyes with Surgery (%)	Patients (%)
Corrected Visual Acuity
	20/25 or Better	217	33.9	41.2
	Worse than 20/25	90	14.0	17.1
	Not Recorded	312	48.7	59.2
Uncorrected Visual Acuity
	20/25 or Better	140	21.8	26.6
	Worse than 20/25	213	33.2	40.4
	Not Recorded	271	42.3	51.4
Target Visual Acuity Achieved?
	Yes	434	67.7	82.4
	No	15	2.3	2.8
	Not Recorded	175	27.3	33.2

Notes: Calculated by dividing the results in a given category by the total number of eyes with surgery (N = 641). Results entered as “Not Applicable” are not summarized, so number of eyes summarized at an individual POD may not equal total number of eyes, and percentages may not add up to 100%. At each timepoint, subjects are counted once using their worst result. Results entered as “Not Recorded,” “Not Done,” or left missing are counted as “Not Recorded.”.

Figure 3 Mean intraocular pressure (IOP) by POD for all eyes undergoing surgery (n=641) and eyes with glaucoma (n = 80).

Table 3 Treatment-Emergent Adverse Events Spontaneously Reported by Investigators

AE Term Reported	Severity	Treatment Relationship (Physician/Investigator Judgment)	Outcome
Increased IOP on POD 1	Mild	Not related	Recovered/resolved
Rebound iritis at POD 30	Mild	Not related	Recovered/resolved
Retina peripheral hole	Mild	Not related	Recovered/resolved
Corneal swelling	Moderate	Possibly related	Recovered/resolved
Corneal edema	Moderate	Possibly related	Recovered/resolved
Rebound iritis	Mild	Not related	Recovered/resolved
High IOP	Mild	Not related	Recovered/resolved
High IOP	Moderate	Probably related	Recovered/resolved
Rebound iritis	Mild	Not related	Recovered/resolved
High IOP^[a]	Moderate	Not related	Recovered/resolved
Diffuse corneal edema^[a]	Moderate	Not related	Recovered/resolved
Retained cortex in anterior chamber^[a]	N/A	Not related	Recovered/resolved
High IOP	Mild	Not related	Recovered/resolved
High IOP	Moderate	Not related	Recovered/resolved
Hypotony maculopathy	Moderate	Not related	Recovered/resolved with sequelae
2+ corneal edema	Mild	Not related	Recovered/resolved with sequelae
Study drug on optic	Mild	Definitely related	Recovering/resolving
Blurred vision	Mild	Definitely related	Recovered/resolved
Corneal edema	Mild	Possibly related	Recovered/resolved
Rebound inflammation	Moderate	Not related	Recovered/resolved
Corneal edema	Moderate	Definitely related	Recovered/resolved
Intraocular pressure elevation	Moderate	Probably related	Recovered/resolved

Note: ^[a]These 3 AEs occurred in the same patient.

Abbreviations: AE, adverse event; IOP, intraocular pressure; POD, postoperative day.