A Phase 2 Study Evaluating the Safety and Efficacy of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy

Phase 2 Completed 40 enrolled Aerie Pharmaceuticals

RandomizedParallel-groupOpen-labelTreatment

Summary

Two different dosing regimens (QD and BID) of netarsudil will be studied to evaluate their efficacy in reducing or resolving corneal edema in subjects with FCD.

Timeline

Start: 2020-09-17
Primary completion: 2021-08-11
Completion: 2021-08-11

Outcome

Met primary endpoint

paper Primary endpoint was mean CCT change from baseline at week 4. Results: Netarsudil QD and BID significantly reduced CCT at week 4 PMID 36327101 ↗

Publications

Lindstrom RL, Lewis AE, Holland EJ, Sheppard JD, Hovanesian JA, Senchyna M, Hollander DA. Phase 2, Randomized, Open-Label Parallel-Group Study of Two Dosing Regimens of Netarsudil for the Treatment of Corneal Edema Due to Fuchs Corneal Dystrophy. J Ocul Pharmacol Ther. 2022 Dec;38(10):657-663. doi: 10.1089/jop.2022.0069. Epub 2022 Nov 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Netarsudil	Small molecule	0.02 %	Topical