Continued improvements may motivate patients to stay on treatment longer.2,4
Study 2. Study 1 found similar results at Days 28 and 84.6
Central Corneal Staining
Visual Acuity
bBased on a pooled analysis of Study 1 and Study 2.3
bBased on a pooled analysis of Study 1 and Study 2.3
(vs 56.9% for vehicle; P=0.02) At baseline, 38.3%
of patients taking CEQUA had complete
clearing (vs 37.5% with vehicle).
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
The most common adverse events reported in patients were instillation site pain (22%) and conjunctival hyperemia (6%).7
CEQUA® (cyclosporine ophthalmic solution) 0.09% is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye).
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.
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
CEQUA® (cyclosporine ophthalmic solution) 0.09% is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye).
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.
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.