CEQUA® delivers results as fast as 2 weeks and continued improvements over time1-3

Continued improvements may motivate patients to stay on treatment longer.2,4

2-WEEK RESULTS

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CEQUA improved total corneal staining after just 14 days1

Chart showing results for CEQUA vs vehicle: improved corneal staining after 14 days

Dry eye disease (DED) patients improved after switching
from Restasis® to CEQUA5

1-MONTH RESULTS

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Patients treated with CEQUA experienced a statistically significant reduction in total corneal staining2,6,8

Chart showing a statistically significant reduction in total corneal staining at 1 month for CEQUA vs vehicle

Study 2. Study 1 found similar results at Days 28 and 84.6

Clear fluorescein staining image of eye post-CEQUA therapy

POST-CEQUA THERAPY

TBUT 12 s OD
Clear fluorescein
staininga

Visible Clinical Improvements

Mild fluorescein staining image of eye pre-CEQUA therapy

PRE-CEQUA THERAPY

TBUT 9 s OD
Mild fluorescein staininga

Visible Clinical Improvements

Study 2

Patients treated with CEQUA experienced a reduction in total corneal staining at 1-, 2-, and 3-month timepoints2

Study 1 found similar results at Days 28 and 846

aImages are not from clinical studies. Images are of actual CEQUA patients and were supplied courtesy of Laura M. Periman, MD, and Sathi Maiti, OD.

Day 28 calendar image

Patients reported a meaningful reduction in chronic dry eye symptom severity8

Study 2. Study 1 found similar results at Days 28 and 84.6

2-MONTH RESULTS

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Statistically significant improvements in visual acuity3,b

Central Corneal Staining

Chart showing statistically significant improvements in visual acuity for CEQUA patients as early as Day 56 vs vehicle

bBased on a pooled analysis of Study 1 and Study 2.3

Snellen eye chart

Improvements in visual acuity correlated with reduced central corneal staining as early as day 562,3

bBased on a pooled analysis of Study 1 and Study 2.3

3-MONTH RESULTS

Eye graphic image

65% of central corneas were completely clear2

(vs 56.9% for vehicle; P=0.02) At baseline, 38.3%
of patients taking CEQUA had complete
clearing (vs 37.5% with vehicle).

Teardrop that says “2x”

Nearly double tear production7

More CEQUA patients experienced a clinically
meaningful improvement in tear production at
3 months (≥10 mm change from baseline in
Schirmer test score) compared to vehicle
across 2 studies.7

CEQUA clinical trial safety

The most common adverse events reported in patients were instillation site pain (22%) and conjunctival hyperemia (6%).7

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Indications and Usage

CEQUA® (cyclosporine ophthalmic solution) 0.09% is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye).

Important Safety Information

WARNINGS AND PRECAUTIONS

Potential for Eye Injury and Contamination: To avoid the potential for eye injury and contamination, advise patients not to touch the vial tip to the eye or other surfaces.

Use with Contact Lenses: CEQUA should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of CEQUA ophthalmic solution.

Adverse Reactions

The most common adverse reactions reported in greater than 5% of patients were pain on instillation of drops (22%) and conjunctival hyperemia (6%). Other adverse reactions reported in 1% to 5% of patients were blepharitis, eye irritation, headache, and urinary tract infection.

Please see the Full Prescribing Information.

 

References: 1. Schechter BA, Urbieta M, Bacharach J, et al. Effect of OTX-101 in patients with dry eye disease at day 14 of treatment: ocular surface endpoint results from the phase 2b/3 clinical trial. Clin Ophthalmol. 2022;16:4145-4151. 2. Goldberg DF, Malhotra RP, Schechter BA, Justice A, Weiss SL, Sheppard JD. A phase 3, randomized, double-masked study of OTX-101 ophthalmic solution 0.09% in the treatment of dry eye disease. Ophthalmology. 2019;126(9):1230-1237. 3. Malhotra R, Devries DK, Luchs J, et al. Effect of OTX-101, a novel nanomicellar formulation of cyclosporine A, on corneal staining in patients with keratoconjunctivitis sicca: A pooled analysis of phase 2b/3 and phase 3 studies. Cornea. 2019;38:1259-1265. 4. Karpecki P, Barghout V, Schenkel B, et al. A retrospective analysis of real-world treatment patterns in patients with dry eye disease receiving CEQUA, Restasis, or Xiidra. Poster presented at AMCP Nexus; October 11-14, 2022; National Harbor, MD. 5. Johnston, J. Effect of OTX-101 0.09% on corneal staining and SANDE scores in patients with dry eye disease uncontrolled on cyclosporine ophthalmic emulsion 0.05%. Abstract presented at American Academy of Optometry 2023;October 12, 2023; New Orleans, LA. 6. Tauber J, Schechter BA, Bacharach J, et al. A phase II/III, randomized, double-masked, vehicle-controlled, dose-ranging study of the safety and efficacy of OTX-101 in the treatment of dry eye disease. Clin Ophthalmol. 2018;12:1921-1929. 7. CEQUA [package insert]. Cranbury, NJ: Sun Pharmaceutical Industries, Inc.; 2022. 8. Data on file. Cranbury, NJ: Sun Pharmaceutical Industries, Inc. 9. Effect of CEQUA in Subjects with Dry Eye Disease, ClinicalTrials.gov identifier NCT04357795. Updated Sept 09, 2022. Accessed August 29, 2023. https://www.clinicaltrials.gov/study/NCT04357795

Indications and Usage

CEQUA® (cyclosporine ophthalmic solution) 0.09% is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye).

Important Safety Information

WARNINGS AND PRECAUTIONS

Potential for Eye Injury and Contamination: To avoid the potential for eye injury and contamination, advise patients not to touch the vial tip to the eye or other surfaces.

Use with Contact Lenses: CEQUA should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of CEQUA ophthalmic solution.

Adverse Reactions

The most common adverse reactions reported in greater than 5% of patients were pain on instillation of drops (22%) and conjunctival hyperemia (6%). Other adverse reactions reported in 1% to 5% of patients were blepharitis, eye irritation, headache, and urinary tract infection.

Please see the Full Prescribing Information.

© 2024 Sun Ophthalmics, a division of Sun Pharmaceutical Industries, Inc. All rights reserved.

CEQUA and NCELL are registered trademarks of Sun Pharmaceutical Industries Limited.

All other trademarks are the property of their respective owners.

PM-US-CQA-1124 07/2024