Opus Gains FDA Fast Track Status for Phentolamine Drops for Night Driving Impairment

Opus Genetics announced Feb. 26 that the US FDA had granted fast track designation to the company’s phentolamine eye drop candidate for night driving impairment in keratorefractive patients.

Ocuphire Pharma acquired Opus in October 2024 in an all-stock transaction. The combined company operates under the Opus name out of offices in Durham, North Carolina.

Ocuphire developed phentolamine ophthalmic solution (0.75%), which gained FDA approval under the name Ryzumvi in September 2023 for the reversal of pharmacologically induced mydriasis. Ryzumvi was launched in April 2024 by Ocuphire’s commercial partner, Viatris.

The formulation is designed to modulate pupil size by blocking the α1 receptors found only on the iris dilator muscle, without affecting the ciliary muscle. Onset of action generally occurs in 30 minutes.

Opus said enrollment in the Phase III LYNX-2 trial—investigating phentolamine for visual loss in low light conditions associated with keratorefractive surgery—is expected to be complete in H1-2025. The primary endpoint is a gain of three lines (or 15 letters) or more of distance vision on a low contrast chart in low light conditions after 15 days of daily dosing.

The eye drop is also under development for presbyopia. Enrollment in the Phase III VEGA-3 presbyopia trial is complete, the company said. Topline data were expected in Q1-2025.