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Cited by 28Ocular Surface and Contact LensAdvanced Drug Delivery SystemsSalivary Gland Disorders and Functions

Efficacy and safety of OTX-101, a novel nanomicellar formulation of cyclosporine A, for the treatment of keratoconjunctivitis sicca: pooled analysis of a phase 2b/3 and phase 3 study

Sheppard, John, Kannarr, Shane, Luchs, Jodi, Malhotra, Ranjan, Justice, Angela, Ogundele, Abayomi, Darby, Charles, Bacharach, Jason·2020·Eye & Contact Lens: Science & Clinical Practice
DOI 10.1097/icl.0000000000000636
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Abstract

BACKGROUND: OTX-101 (CEQUA™) is approved in the United States for treatment of keratoconjunctivitis sicca (KCS). This pooled analysis of 2 studies (phase 2b/3 and phase 3) evaluates the efficacy and safety of OTX-101 0.09% in the intent-to-treat (ITT) population and the subgroup of patients with a baseline Schirmer score less than 10 mm. METHODS: In these randomized, multicenter, double-masked, vehicle-controlled studies, patients received 1 drop of either OTX-101 or vehicle in both eyes twice daily. A Schirmer's test was performed at baseline and day 84/early discontinuation. Symptom Assessment iN Dry Eye (SANDE) scores and adverse events were monitored at each visit. RESULTS: The pooled analysis included 523 and 525 patients randomized to OTX-101 0.09% and vehicle, respectively. In the ITT population, 16.6% of eyes receiving OTX-101 and 9.0% of eyes receiving vehicle showed a day 84 increase in Schirmer score ≥10 mm from baseline (P<0.0001). In the subgroup with Schirmer score less than 10 mm at baseline, 18.7% and 10.2% of eyes receiving OTX-101 and vehicle, respectively, exhibited this outcome (P=0.0001). The mean (SD) percent change from baseline in global SANDE scores on day 84 in the ITT population was -29.0% (39.0%) and -30.4% (39.5%) for OTX-101 and vehicle groups, respectively. In the subgroup, the mean (SD) percent change was -27.3% (39.7%) and -31.4% (38.3%) for OTX-101 and vehicle groups, respectively. Adverse events were mostly mild to moderate. CONCLUSIONS: OTX-101 improved tear production compared with vehicle. Both OTX-101 and vehicle showed improved SANDE scores over baseline. OTX-101 was well tolerated in patients with KCS.

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Authors
Sheppard, J., Kannarr, S., Luchs, J., Malhotra, R., Justice, A., Ogundele, A., Darby, C., & Bacharach, J.
Affiliations
Virginia Eye Consultants (US)
Corresponding author
Sheppard, John
ORCID
Venue
Eye & Contact Lens: Science & Clinical Practice
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2020-01
Volume
46
Issue
1
Pages
S14-S19
ISSN
  • 0733-8902 (ISSN-L)
  • 1542-2321
DOI
10.1097/icl.0000000000000636
OpenAlex
W2966827320
Cited by
28
References
20
Citations by year
2026: 4 · 2025: 6 · 2024: 3 · 2023: 3 · 2022: 4 · 2021: 4 · 2020: 4
FWCI
2.78
Type
journal article
Language
en
Open access
closed
Locations
  • Eye & Contact Lens Science & Clinical Practice (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ocular Surface and Contact Lens
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Advanced Drug Delivery Systems
  • Health Sciences › Medicine › Physiology › Salivary Gland Disorders and Functions
Keywords
cyclosporine, dry eye, tear secretion, ocular drug delivery, adverse events, vehicle comparison, pooled analysis, treatment efficacy and safety, eye drops
MeSH terms
Dose-Response Relationship, Drug, Double-Blind Method, Female, Follow-Up Studies, Humans, Immunosuppressive Agents, Keratoconjunctivitis Sicca, Male, Middle Aged, Ophthalmic Solutions, Tears, Cyclosporine, Treatment Outcome

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