July 2019
Volume 60, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2019
Efficacy and safety of OTX-101, a novel nanomicellar cyclosporine formulation, in patients with keratoconjunctivitis sicca: Results of a pooled analysis
Author Affiliations & Notes
  • Melissa Toyos
    Toyos Clinic, Nashville, Tennessee, United States
  • Damien F. Goldberg
    Jules Stein Eye Institute, Los Angeles, California, United States
    Wolstan & Goldberg Eye Associates, Torrance, California, United States
  • Joseph Tauber
    Tauber Eye Center, Kansas City, Missouri, United States
  • Rajan Malhotra
    Ophthalmology Associates, St. Louis, Missouri, United States
  • Charles Darby
    Sun Pharma Advanced Research Company Ltd, Princeton, New Jersey, United States
  • Abayomi Ogundele
    Sun Pharmaceuticals Industries, Inc., Princeton, New Jersey, United States
  • Jodi Luchs
    Hofstra Northwell School of Medicine, Hempstead, New York, United States
  • Footnotes
    Commercial Relationships   Melissa Toyos, Bausch & Lomb Inc (F), Carl Zeiss AG (F), Eyevance Pharmaceuticals (C), Iridex Corporation (F), Kala Pharmaceuticals Inc (F), Lumenis Ltd (F), Magellan Health (F), Mallinckrodt Pharmaceuticals (F), MiXto Laser (F), Ocular Technologies (F), Oculos Clinical Research (F), Opternative (F), RevitaLid Inc. (F), Shire plc (F), Sun Pharmaceutical Industries Ltd (F), Verana Health (F); Damien Goldberg, Aerie Pharmaceuticals Inc (C), Allergan plc (C), Bausch Health Companies Inc (F), Carl Zeiss AG (F), Cloudbreak Therapeutics LLC (F), Glaukos Corporation (F), Johnson & Johnson Vision Care Inc (F), Kala Pharmaceuticals Inc (F), Ocular Science (F), Ocular Therapeutix Inc (F), Sun Pharmaceutical Industries Ltd (F), TearSolutions Inc (F); Joseph Tauber, Sun Pharmaceutical Industries Ltd (F), Sun Pharmaceutical Industries Ltd (C); Rajan Malhotra, Abbott Laboratories (F), Alcon (F), Allergan plc (F), Bausch & Lomb Inc (F), BioD LLC (F), InSite Vision Inc (F), Katena Products Inc (F), NicOx S.A. (F), OASIS Medical Inc (F), Shire plc (F), TearScience Inc (F); Charles Darby, SPARC Ltd (C); Abayomi Ogundele, Sun Pharmaceutical Industries Ltd (E); Jodi Luchs, Alcon (F), Allergan plc (F), Bausch & Lomb Inc (F), CXLO (F), Insightful Solutions (F), Shire plc (F), Sun Pharmaceutical Industries Ltd (F), TearLab Corporation (F)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2019, Vol.60, 6736. doi:
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      Melissa Toyos, Damien F. Goldberg, Joseph Tauber, Rajan Malhotra, Charles Darby, Abayomi Ogundele, Jodi Luchs; Efficacy and safety of OTX-101, a novel nanomicellar cyclosporine formulation, in patients with keratoconjunctivitis sicca: Results of a pooled analysis. Invest. Ophthalmol. Vis. Sci. 2019;60(9):6736.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Keratoconjunctivitis sicca (KCS) is the most common reason for seeking medical eye care, representing a growing health and cost burden. OTX-101 (CEQUA™), a novel nanomicellar cyclosporine formulation, has been approved in the US for the treatment of KCS. We present a pooled analysis of efficacy and safety from a phase 2b/3 and a phase 3 randomized, multicenter, double-masked, vehicle-controlled study evaluating OTX-101 in patients with KCS.

Methods : In both studies, patients received 1 drop of either OTX-101 0.09% or vehicle in affected eye(s) twice daily. Schirmer’s test was performed at baseline and on day 84/early discontinuation. Symptoms were assessed using Symptom Assessment iN Dry Eye (SANDE) questionnaire in both studies at screening; baseline; and days 28, 56, and 84/early discontinuation. Safety measures included adverse event (AE) monitoring throughout both studies.

Results : A total of 523 patients receiving OTX-101 and 525 receiving vehicle in the intent-to-treat population were analyzed. Mean baseline Schirmer’s scores (standard deviation [SD]) for the OTX-101 and vehicle groups were 12.02 (8.595) and 12.12 (8.415), respectively. The number (percentage [%]) of eyes with an increase in Schirmer’s score of ≥10 mm on day 84 relative to baseline was 174 (16.6%) and 95 (9.0%) for the OTX-101 and vehicle groups, respectively (P <0.0001). Mean percent change from baseline (SD) was 63.2% (193.37%) and 37.1% (167.69%), respectively (P <0.0001). The number (%) of eyes with >50% increase in Schirmer’s score was 342 (32.7%) vs 249 (23.7%), respectively (P <0.0001). Mean (SD) change from baseline in global SANDE score on day 84 was −18.55 (23.648) for the OTX-101 group and −18.88 (23.084) for the vehicle group (P = 0.6488). Most common AEs (% of patients in OTX-101 vs vehicle arm) included instillation site pain (21.8% vs 4.0%), conjunctival hyperemia (5.7% vs 3.6%), and eye irritation (1.1% vs 1.1%).

Conclusions : OTX-101 significantly improved tear production compared with vehicle. Both OTX-101 and vehicle improved SANDE scores over baseline, although the treatment difference was not statistically significant, suggesting both can improve symptoms of KCS. OTX-101 was well tolerated in patients with KCS.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.

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