Evidence map›Paper›PMID 30617777›Full record

ReviewPharmaceutical research2019

Ocular Pharmacokinetics of a Topical Ophthalmic Nanomicellar Solution of Cyclosporine (Cequa®) for Dry Eye Disease.

Abhirup Mandal, Vrinda Gote, Dhananjay Pal, Abayomi Ogundele, Ashim K Mitra

Registry-linked trialAbstract readReview
PubMed Publisher
In one paragraph

Review in Pharmaceutical research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06392438 (Combination of 0.09% Cyclosporine and Intense Pulsed Light), which is not on this map. Cited by 71 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
71citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06392438 phase3unknown statusnot on this mapstarted 2024, after this paper: background citation

Combination of 0.09% Cyclosporine and Intense Pulsed Light (IPL) Therapy for the Treatment of Dry Eye Disease in Symptomatic Contact Lens Wearers: a Sham-Controlled Randomized Clinical Trial

TypeinterventionalSponsorUniversité de SherbrookeRan2024 to 2025Enrolled44ConditionsDry Eye, Contact Lens ComplicationArmsCycloSPORINE Ophthalmic, Intense Pulsed Light, Sham Intense Pulse Light
3 · Its place in the literature

Who cites it

71 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Guideline
  2. Pooled it
  3. Effect of OTX-101 0.09% ciclosporin solution on clinical signs of dry eye disease in patients with moderate-to-severe corneal damage: a post-hoc analysis of randomized clinical trials.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026
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  14. Recent advances and future challenges in nanosystems for ocular drug delivery.The Journal of pharmacology and experimental therapeutics · 2025
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11 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Abhirup MandalDivision of Pharmacology and Pharmaceutical Sciences, School of Pharmacy, University of Missouri, 2464 Charlotte Street, Kansas City, MO, 64108, USA.ORCID http://orcid.org/0000-0002-2543-4994
Vrinda GoteDivision of Pharmacology and Pharmaceutical Sciences, School of Pharmacy, University of Missouri, 2464 Charlotte Street, Kansas City, MO, 64108, USA.
Dhananjay PalDivision of Pharmacology and Pharmaceutical Sciences, School of Pharmacy, University of Missouri, 2464 Charlotte Street, Kansas City, MO, 64108, USA.
Abayomi OgundeleSun Pharmaceutical Industries Ltd., Sun Ophthalmics Inc., 2 Independence Way, Princeton, NJ, 08540, USA.
Ashim K MitraDivision of Pharmacology and Pharmaceutical Sciences, School of Pharmacy, University of Missouri, 2464 Charlotte Street, Kansas City, MO, 64108, USA. mitraa@umkc.edu.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Cequa®, a unique and first-in-class preservative free cyclosporine-A (CsA) nanomicellar topical formulation was recently approved by US FDA for treatment of dry eye disease or keratoconjuntivitis sicca (KCS). Being highly hydrophobic, CsA is currently available as an oil based emulsion, which has its own shortcomings. Developing an aqueous and clear formulation of CsA is imperative yet a challenging need in the quest for a safe and better drug product. In this regard, a novel, clear, aqueous nanomicellar solution of CsA was developed which has the potential to deliver therapeutic concentrations of CsA with minimal discomfort to patients. Highly promising pre-clinical results of Cequa® (OTX-101), has led to its advancement to the clinical trials. Phase III clinical trials have demonstrated that OTX-101 is highly effective, safe, and has a rapid onset of action in treating KCS. This review presents a comprehensive insight on formulation development, preclinical and clinical pharmacokinetic results of Cequa®. Additionally, the translational development of Cequa® from the laboratory benchtop to patient bedside has been discussed.

Indexed as

Administration, OphthalmicClinical Trials, Phase III as TopicCyclosporineDry Eye SyndromesEyeHumansImmunosuppressive AgentsMicellesNanoparticlesOphthalmic SolutionsTreatment OutcomeCyclosporineImmunosuppressive AgentsMicellesOphthalmic Solutionsformulationkeratoconjunctivits sicca (KCS)micellesnon-ionicocular drug deliveryOTX-101tear

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.