One Year of Netarsudil and Latanoprost Fixed-Dose Combination for Elevated Intraocular Pressure
| Autor: | Casey Kopczynski, Nancy Ramirez, Savak Teymoorian, Richard A Lewis, Dale W. Usner, Hayley McKee, Theresa Heah, Jacob W. Brubaker |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
Intraocular pressure
medicine.medical_specialty genetic structures medicine.drug_class Fixed-dose combination Ocular hypertension 01 natural sciences law.invention 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Randomized controlled trial law Ophthalmology medicine 0101 mathematics Latanoprost business.industry 010102 general mathematics General Medicine medicine.disease eye diseases Prostaglandin analog chemistry Tolerability 030221 ophthalmology & optometry sense organs Prostaglandin analogue business |
| Zdroj: | Ophthalmology Glaucoma. 3:327-338 |
| ISSN: | 2589-4196 |
| Popis: | Purpose A phase 3 trial (MERCURY-1) investigated efficacy and safety of a once-daily, fixed-dose combination (FDC) of netarsudil and latanoprost, compared with each active component, in reducing elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). A planned 3-month analysis demonstrated the superiority of netarsudil/latanoprost FDC over its individual active components at every assessment. Herein, the 12-month efficacy and safety of netarsudil/latanoprost FDC are reported. Design Double-masked, randomized, active-controlled, parallel-group trial. Participants Patients had unmedicated IOP >20 to am and met other standard criteria for OAG or OHT. Methods Randomization to once-daily netarsudil 0.02%/latanoprost 0.005% FDC (n = 238), netarsudil 0.02% only (n = 243), or latanoprost 0.005% only (n = 237). Patients instilled study drug into each eye between 8:00 pm and 10:00 pm . Main Outcome Measures IOP was obtained at 8:00 am , 10:00 am , and 4:00 pm on day 1 (baseline); at weeks 2 and 6; and at months 3, 6, 9, and 12. Ocular and systemic safety were evaluated up to month 12. Results Netarsudil/latanoprost FDC maintained statistically superior IOP lowering compared to its components at every assessment for 12 months. Least squares mean diurnal IOP (± standard error) at month 12 was 16.2 ± 0.23 mmHg for netarsudil/latanoprost FDC, 17.9 ± 0.20 mmHg for netarsudil, and 17.6 ± 0.18 mmHg for latanoprost (P Conclusions Results at 12 months revealed superior efficacy for netarsudil/latanoprost FDC compared with the individual components, netarsudil and latanoprost, at every time point assessed and an ocular tolerability profile similar to that of netarsudil alone. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|