Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) in Subjects With Dim Light Vision Disturbances

Summary

The objectives of this study are: * To evaluate the efficacy of Nyxol to improve mesopic low contrast visual acuity (mLCVA) in subjects with Dim Light Vision Disturbances (DLD) * To evaluate efficacy of Nyxol to improve visual performance * To evaluate the safety of Nyxol

Timeline

Start

2020-12-30

Primary completion

2022-05-19

Completion

2022-05-19

Outcome

Met primary endpoint

release “Summary of LYNX-1 Data The FDA-agreed primary endpoint was met” opusgtx.com ↗

release “These Phase 2 data were used to inform the design of the Phase 3 LYNX-1 trial in NVD that met its primary endpoint” opusgtx.com ↗

release “the LYNX-1 Phase 3 study met its primary endpoint, with a statistically significant greater percentage of Phentolamine Ophthalmic Solution 0.75%-treated participants” opusgtx.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Phentolamine	Small molecule	0.75 %	Topical

Indications