CEQUA

Blood concentrations of cyclosporine after twice daily topical ocular administration of CEQUA into each eye of healthy subjects for up to 7 days, and once on Day 8, were either not detectable or were marginally above the lower limit of assay quantitation of 0.100 ng/mL (range 0.101 to 0.195 ng/mL) for up to 2 hours after a single dose, and up to 4 hours after multiple doses.

Two multicenter, randomized, adequate and well-controlled clinical studies treated 1,048 patients with keratoconjunctivitis sicca (NCT # 02254265 and NCT # 02688556). In both studies, compared to vehicle at Day 84, there was a statistically significant (p<0.01) higher percentage of eyes with increases of ≥ 10 mm from baseline in Schirmer wetting. This effect was seen in approximately 17% of CEQUA-treated patients versus approximately 9% of vehicle-treated patients. Tear Production OTX-101-2014-001 OTX-101-2016-001 CEQUA N=152 Vehicle N=152 CEQUA N=371 Vehicle N=373 ≥ 10-mm increase in tear pro...

The most common adverse reactions following the use of CEQUA (cyclosporine ophthalmic solution) 0.09% was instillation site pain (22%) and conjunctival hyperemia (6%) ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-406-7984 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot...

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To avoid the potential for eye injury and contamination, advise patients not to touch the vial tip to the eye or other surfaces ( 5.1 ). 5.1 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. 5.2 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. Lens...