Double-masked Study of PG324 Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension

Summary

To evaluate ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to netarsudil (AR-13324) ophthalmic solution 0.02% and latanoprost ophthalmic solution 0.005%

Timeline

Start

2016-02

Primary completion

2017-03

Completion

2017-03

Outcome

Met primary endpoint

paper The netarsudil/latanoprost FDC met criteria for superiority compared with each active component (p < 0.0001 for all nine time points). PMID 32166538 ↗

registry analysis (superiority test); PG324 Ophthalmic Solution vs Netarsudil (AR-13324) Ophthalmic Solution 0.02%; p <0.0001; t-test, 2 sided NCT02674854 ↗

registry analysis (superiority test); PG324 Ophthalmic Solution vs Latanoprost Ophthalmic Solution 0.005%; p <0.0001; t-test, 2 sided NCT02674854 ↗

Publications

• Results Walter TR, Ahmed IK et al. Ophthalmology glaucoma, 2019, pg. 1-10 https://doi.org/10.1016/j.ogla.2019.03.007
• Asrani S, Bacharach J, Holland E, McKee H, Sheng H, Lewis RA, Kopczynski CC, Heah T. Fixed-Dose Combination of Netarsudil and Latanoprost in Ocular Hypertension and Open-Angle Glaucoma: Pooled Efficacy/Safety Analysis of Phase 3 MERCURY-1 and -2. Adv Ther. 2020 Apr;37(4):1620-1631. doi: 10.1007/s12325-020-01277-2. Epub 2020 Mar 12.
• Wisely CE, Sheng H, Heah T, Kim T. Effects of Netarsudil and Latanoprost Alone and in Fixed Combination on Corneal Endothelium and Corneal Thickness: Post-Hoc Analysis of MERCURY-2. Adv Ther. 2020 Mar;37(3):1114-1123. doi: 10.1007/s12325-020-01227-y. Epub 2020 Jan 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Latanoprost	Small molecule	0.005 %	Other
Comparator	Netarsudil	Small molecule	0.02 %	Other
Subject	PG324	Unknown	0.005 %	Other
Subject	PG324	Unknown	0.02 %	Other

Indications