Opus Genetics releases topline results from LYNX-2 evaluating phentolamine ophthalmic solution 0.75%

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Opus Genetics has released positive topline results from LYNX-2, its phase 3 clinical trial evaluating phentolamine ophthalmic solution 0.75% for the treatment of chronic night driving impairment in keratorefractive patients with reduced mesopic vision.

Phentolamine ophthalmic solution 0.75% is a non-selective alpha-1 and alpha-2 adrenergic antagonist to reduce pupil size. The company noted that phentolamine ophthalmic solution 0.75% blocks the alpha-1 receptors found on the radial iris dilator muscles, which are activated by the alpha-1 adrenergic receptors, without affecting the ciliary muscle, which reduces risks such as retinal tears or detachment associated with older parasympathomimetic agents.

LYNX-2 was a randomized, double-masked, placebo-controlled trial in 199 patients who had previously undergone keratorefractive surgery and reported decreased visual acuity under mesopic low-contrast conditions. Patients were randomized to receive either phentolamine or placebo, which was self-administered in both eyes nightly, treated, and observed over 6 weeks.

According to the company, the LYNX-2 study (NCT06349759) met its primary endpoint of a gain of 3 lines, or 15 letters, or more of distance vision improvement on a low-contrast chart in low-light conditions after 15 days of dosing. In LYNX-2, 17.3% of patients treated with phentolamine ophthalmic solution 0.75% achieved a ≥15-letter Early Treatment Diabetic Retinopathy Study (ETDRS) (≥3-line) improvement in Mesopic Low Contrast Distance Visual Acuity (mLCVA) at Day 15, compared to 9.2% in the placebo group (p<0.05).

George Magrath, MD, CEO of Opus Genetics, commented on the trial results in a press release from the company.

“Patient-reported outcome results demonstrated improvements in night-driving vision, enabling patients to function more effectively in low-light, low-contrast conditions,” said Magrath. “This data builds on earlier results from the LYNX-1 trial and provides evidence of efficacy for this condition, which currently has no FDA-approved therapies. We believe this therapy could address a true unmet need and could offer meaningful benefits to keratorefractive patients experiencing glare, halos, and reduced functional vision in low-light, low-contrast environments.”

LYNX-2 patients will continue to be monitored for long-term safety over 48 weeks.

References:

1. Opus Genetics Announces LYNX-2 Phase 3 Trial Met its Primary Endpoint for Phentolamine Ophthalmic Solution 0.75% in Keratorefractive Patients with Visual Disturbances Under Mesopic, Low-Contrast Conditions. Published June 2, 2025. Accessed June 2, 2025. https://ir.opusgtx.com/press-releases/detail/488/opus-genetics-announces-lynx-2-phase-3-trial-met-its-primary-endpoint-for-phentolamine-ophthalmic-solution-0-75-in-keratorefractive-patients-with-visual-disturbances-under-mesopic-low-contrast-conditions