VUITY™ has been studied in two Phase 3 trials

Multicenter, double-masked, randomized, parallel-group, vehicle-controlled, 30-day, Phase 3 studies (GEMINI 1 and GEMINI 2) in participants with presbyopia aged 40 to 55 years with mesopic, high-contrast distance-corrected near visual acuity (DCNVA) of 20/40 (J3) to 20/100 (J10) in each eye at the screening and baseline visits. Participants administered one drop once daily in each eye.1,2

Improved

near and intermediate vision

without compromising distance vision1

without compromising
distance vision1

Primary endpoint was the proportion of participants gaining ≥3 lines in mesopic, high-contrast, binocular DCNVA without losing more than 1 line (5 letters) of corrected distance visual acuity (CDVA) with the same refractive correction at Day 30, Hour 3.1 Change from baseline in photopic, high-contrast, binocular distance-corrected intermediate visual acuity (DCIVA) at Day 30, Hour 3 was a prespecified secondary endpoint.3

Primary endpoint was the proportion of participants gaining ≥3 lines in mesopic, high-contrast, binocular DCNVA without losing more than 1 line (5 letters) of corrected distance visual acuity (CDVA) with the same refractive correction at Day 30, Hour 3.1

Change from baseline in photopic, high-contrast, binocular distance-corrected intermediate visual acuity (DCIVA) at Day 30, Hour 3 was a prespecified secondary endpoint.3

Near vision (DCNVA) measured at 40 cm       For illustrative purposes only. All distances were studied on an eye chart.

The data in the chart below shows the results for GEMINI 1, click the GEMINI 2 button to see the results for that study.

Significantly more participants
gained ≥3 lines
in mesopic (low light) DCNVA,
without losing more than 1 line (5 letters) of CDVA at Day 30, Hour 3 vs vehicle*1

*GEMINI 1: 31% of participants on VUITY™ vs 8% vehicle; p<0.01; intent-to-treat (ITT) population.1 GEMINI 2: 26% of participants on VUITY™ vs 11% vehicle; p<0.01; ITT population.1


Proportion of participants achieving ≥ 3-line gain in mesopic DCNVA at Day 30 (ITT population)1

Trial Data
Trial Data

*GEMINI 1: 31% of participants on VUITY™ vs 8% vehicle; p<0.01; intent-to-treat (ITT) population.1 GEMINI 2: 26% of participants on VUITY™ vs 11% vehicle; p<0.01; ITT population.1


Proportion of participants achieving ≥ 3-line gain in mesopic DCNVA at Day 30 (ITT population)1

Trial Data

CI: confidence interval.

Near vision measured at 40 cm

Evaluation of participants achieving

20/40 or better in DCNVA

photopic high-contrast, binocular conditions at Day 30, Hour 34

~9/10

participaints on
VUITYTM achieved

≥ 20/40

Prespecified secondary endpoint at Day 30, hour 3 (prespecified secondary endpoint)3

DCIVA data

Fonts not actual size.


In post-hoc analysis:4

1/3 VUITYTM participants achieved 20/20 DCNVA without losing more than 5 letters of CDVA on Day 30, Hour 1^

GEMINI 1: VUITYTM (n=161), vehicle (n=153). GEMINI 2: VUITYTM (n=193), vehicle (n=119)

At baseline in GEMINI 1, 40.5% (vs 38.8% vehicle) of participants in the VUITYTM group had 20/40 to 20/60 mesopic, high contrast binocular DCNVA.

At baseline in GEMINI 1, 40.5% (vs 38.8% vehicle) of participants in the VUITY™ group had 20/40 to 20/60 mesopic, high-contrast binocular DCNVA. At baseline in GEMINI 2, 48.6% (vs 48.8% vehicle) of participants in the VUITY™ group had 20/40 to 20/60 mesopic, high-contrast binocular DCNVA.

~9/10

participants on
VUITY™ achieved

≥ 20/40

DCNVA at Day 30, Hour 3 (prespecified secondary endpoint)4

  • 84.5% in GEMINI 1 vs 71.9% vehicle4
  • 90.2% in GEMINI 2 vs 77.8% vehicle4
DCIVA data

Fonts not actual size.

Fonts not actual size.

GEMINI 1: VUITY™ (n=161), vehicle (n=153).
GEMINI 2: VUITY™ (n=193), vehicle (n=198).

At baseline in GEMINI 1, 40.5% (vs 38.8% vehicle) of participants in the VUITY™ group had 20/40 to 20/60 mesopic, high contrast binocular DCNVA.

At baseline in GEMINI 1, 40.5% (vs 38.8% vehicle) of participants in the VUITY™ group had 20/40 to 20/60 mesopic, high-contrast binocular DCNVA. At baseline in GEMINI 2, 48.6% (vs 48.8% vehicle) of participants in the VUITY™ group had 20/40 to 20/60 mesopic, high-contrast binocular DCNVA.


In a post-hoc analysis:5

1/3 VUITY™ participants achieved

20/20 DCNVA

without losing more than 5 letters

of CDVA on Day 30, Hour 1^

  • 33.5% in GEMINI 1 vs 7.8% vehicle5
  • 33.2% in GEMINI 2 vs 13.6% vehicle5

^This was not a prespecified endpoint; results could represent chance findings and should be interpreted with caution.

Intermediate vision (DCIVA) measured at 66 cm       For illustrative purposes only. All distances were studied on an eye chart.

Statistically significant
improvement in DCIVA
vs vehicle

Prespecified secondary endpoint:Change from baseline in photopic, high-contrast binocular DCIVA letters at Day 30, Hour 3 (ITT population).3 At Day 30, Hour 3 (prespecified secondary endpoint)3 Mean change from baseline photopic DCIVA letters: GEMINI 1 was 6.6 letters with VUITY™ vs 3.1 vehicle, p<0.05 (mean baseline of 53.4 letters in both groups). GEMINI 2 was 6.4 letters with VUITY™ vs 3.1 vehicle, p<0.05 (mean baseline of 54.1 letters vs 54.4 letters, respectively).

Evaluated in

mesopic and photopic conditions2

Woman reading restaurant menu under mesopic conditions

Images are for illustrative purposes only; all assessments were conducted at clinical study sites. Studies included both emmetropes or nonemmetropes with best distance correction sphere of -4.00 D to +1.00 D (inclusive) and cylinder  ≤  ±2.00 D.

Man reading office paperwork under photopic conditions

Images are for illustrative purposes only; all assessments were conducted at clinical study sites. Studies included both emmetropes or nonemmetropes with best distance correction sphere of -4.00 D to +1.00 D (inclusive) and cylinder  ≤  ±2.00 D.

NEARLY 9/10

Trial participants [N=76] surveyed would ask their eye doctor for VUITYTM §7

§Assessed by a survey in a subset of participants in the VUITYTM arm of GEMINI 1 and GEMINI 2 studies.

Not an actual patient

VUITYTM has been studied in
two Phase 3 clinical trials1

Multicenter, double-masked, randomized, parallel-group, vehicle-controlled, 30-day Phase 3 studies in patients with presbyopia aged 40 to 55 years of age with mesopic, high-contrast DCNVA of 20/40 (J3) to 20/100 (J10) in each eye and at screening and baseline visits.

Diagram of VUITY™ Phase 3 clinical trials GEMINI 1 and GEMINI 2 results

Study assessments:

Participants were evaluated on Day 1, 3, 7, 14 and 30 of the 30-day clinical trial.8

Primary efficacy assessment:

Percentage of participants in the ITT population gaining 3 lines or more from baseline in mesopic, high-contrast, binocular DCNVA without losing more than 1 line (5 letters) of CDVA with the same refractive correction at Day 30, Hour 3.1

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