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
| Autor: | John Sheppard, Jason Bacharach, Shane R Kannarr, Abayomi Ogundele, Jodi Luchs, Charles Darby, Angela Justice, Ranjan Malhotra |
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| Rok vydání: | 2020 |
| Předmět: |
Male
medicine.medical_specialty Population Keratoconjunctivitis Sicca Phases of clinical research 02 engineering and technology 03 medical and health sciences 0302 clinical medicine Double-Blind Method Humans Medicine KERATOCONJUNCTIVITIS SICCA education education.field_of_study Dose-Response Relationship Drug business.industry Middle Aged 021001 nanoscience & nanotechnology Dermatology eye diseases Ophthalmology Treatment Outcome Pooled analysis Tears Cyclosporine 030221 ophthalmology & optometry Female Ophthalmic Solutions 0210 nano-technology business Immunosuppressive Agents Follow-Up Studies |
| Zdroj: | Eye & Contact Lens: Science & Clinical Practice. 46:S14-S19 |
| ISSN: | 1542-2321 |
| DOI: | 10.1097/icl.0000000000000636 |
| Popis: | 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.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.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 (P0.0001). 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.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. |
| Databáze: | OpenAIRE |
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