SAFETY

Most patients found CEQUA® to be comfortable right from the start1,2

Instillation site pain often leads patients with dry eye disease (DED) to stop using certain dry eye treatments.3,a

Instillation site pain (N=524)

Less than 95% of CEQUA patients experienced either no or mild instillation site painLess than 95% of CEQUA patients experienced either no or mild instillation site pain

>95%

of patients experienced either no or mild instillation site pain with CEQUA2,4,a,b

CEQUA clinical trial safetyc
  • The most common adverse events reported in patients were instillation site pain (22%) and conjunctival hyperemia (6%)5
  • Most ocular adverse events reported by patients treated with CEQUA were mild or moderate2
  • Fewer than 3 patients in 100 discontinued CEQUA because of instillation site pain4
  • Discontinuation rate due to ocular adverse events was 3.2% for CEQUA vs 1.1% for vehicle2
  • Incidence of blurred vision was <1%2
CEQUA has no reported taste alterations or contraindications. Appropriate option for nearly all adults with DED. See ref 5, 6

CEQUA has no reported taste alterations or contraindications—an appropriate option for virtually all adults with dry eye disease5,6

aInstillation site pain included burning and stinging.2,4

bThe first time they tried CEQUA, 9 out of 10 patients reported no or mild discomfort after 3 minutes.1

cThe safety of CEQUA was evaluated in clinical trials that included 769 patients who received at least 1 dose of study treatment.5

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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. 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. 2. Data on file. Cranbury, NJ: Sun Pharmaceutical Industries, Inc. 3. White DE, Zhao Y, Ogundele A, et al. Real-world treatment patterns of cyclosporine ophthalmic emulsion and lifitegrast ophthalmic solution among patients with dry eye. Clin Ophthalmol. 2019;13:2285-2292. 4. 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. 5. CEQUA [package insert]. Cranbury, NJ: Sun Pharmaceutical Industries, Inc.; 2022. 6. 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.

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.

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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