Study design
primary endpoints
secondary endpoint

The IOP-lowering effect of VYZULTA^® was evaluated
in two Phase 3 studies (APOLLO & LUNAR)

APOLLO & LUNAR study designs^1,3,4

Randomized, multicenter, double-masked, non-inferiority, pivotal clinical trials performed in the United States and Europe
Study populations included adult males and non-pregnant adult females with open-angle glaucoma or ocular hypertension

APOLLO^1,3

LUNAR^1,4

Study endpoints^1,3,4

Primary efficacy endpoint:

IOP in the study eye measured at 8 AM, 12 PM, and 4 PM at week 2, week 6, and month 3

Secondary efficacy endpoints:

Proportion of subjects with IOP ≤18 mmHg at all 9 time points in the first 3 months
Proportion of subjects with IOP reduction ≥25% at all 9 time points in the first 3 months
Change in mean diurnal IOP from baseline to month 3, 6, 9 and 12

Study design
primary endpoints
secondary endpoint

VYZULTA^® led to greater reductions in mean IOP
when compared to timolol maleate 0.5% at all
evaluation time points (pooled analysis)¹

Patients with open-angle glaucoma or ocular hypertension enrolled in APOLLO and LUNAR had combined average diurnal baseline IOPs of 26.7 mmHg in the VYZULTA^® group and 26.5 mmHg in the timolol maleate 0.5% group.

Comparison of mean IOP by visit and time point (ANCOVA) –
ITT populations with last observation carried forward (pooled analysis)^†‡§¶

Adapted from Product Monograph.¹

VYZULTA^® had an IOP-lowering effect of 9 mmHg from baseline vs. 7.4 mmHg for timolol maleate 0.5% (Pooled studies, month 3, 4 PM evaluation time point):
• Mean IOP was 17.77 mmHg for VYZULTA^® vs. 19.1 mmHg for timolol maleate 0.5% (95% CI: -1.78 to -0.87; p<0.001)

ANCOVA: analysis of covariance; ITT: intent to treat; CI: confidence interval
^† Mean is the LS mean of IOP for the corresponding time point and visit at time-matched overall average baseline under ANCOVA.
^ǂ Treatment difference = VYZULTA^TM minus timolol maleate 0.5%.
^§ Adjusted mean, 95% CI, and p-values are from an ANCOVA model with study (769 or 770) and treatment as fixed effect variables and time-matched baseline mean IOP as a covariate.
^¶ Non-inferiority could be claimed if the upper limit of the CI <1.5 mmHg at all time points of each visit and <1.00 mmHg for at least 5 out of the 9 time points in the efficacy phase. If non-inferiority was determined on the pooled analysis, superiority at each time point could be claimed if the upper limit of the 95% CI <0 mmHg at all time points of each visit in the efficacy phase.

Study design
primary endpoints
secondary endpoint

Statistically significant improvements in pooled secondary endpoints and extension results¹

20.2% of VYZULTA^® patients
attained a mean IOP of ≤18 mmHg vs.
11.2% of timolol maleate 0.5% patients at
all 9 evaluation time points (p=0.001)

32.9% of VYZULTA^® patients had
a ≥25% IOP reduction from baseline vs.
19.0% of timolol maleate 0.5% patients at
all 9 evaluation time points (p=0.001)

Patients who switched over from timolol to VYZULTA^® also experienced additional IOP lowering
(1.1-1.2 mmHg, p≤0.009 for all vs. month 3)

VYZULTA^® demonstrated durability: efficacy was maintained through 12 months of therapy

Adapted from the Product Monograph.¹

The IOP-lowering effect of VYZULTA® was evaluated in two Phase 3 studies (APOLLO & LUNAR)

APOLLO & LUNAR study designs1,3,4

APOLLO1,3

LUNAR1,4

Study endpoints1,3,4