Opus Genetics has announced positive topline results from LYNX-2, a clinical trial evaluating phentolamine ophthalmic solution 0.75% for the treatment of significant, chronic night driving impairment in keratorefractive patients.
Patients who undergo keratorefractive procedures, such as laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), small-incision lenticule extraction (SMILE) and radial keratotomy (RK), often experience vision disturbances including glare, haloes and starbursts, due to increased optical aberrations and light scatter under low-light (mesopic), low-contrast conditions.
These disturbances can significantly impair night driving and daily functioning in dim environments.
The Phase 3 LYNX-2 clinical trial met its primary endpoint of a gain of three lines (or 15 letters) or more of distance vision improvement on a low contrast chart in low light conditions after 15 days of dosing.1
In the study, 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).
Phentolamine ophthalmic solution 0.75% is designed to reduce pupil diameter through a sympatholytic mechanism of action that avoids engaging the ciliary muscle, potentially reducing risks such as retinal tears or detachment associated with older parasympathomimetic agents.
We believe this therapy could address a true unmet need and could offer meaningful benefits to keratorefractive patients…
Addressing an Unmet Need
Opus Genetics CEO Dr George Magrath said the data builds on earlier results from the LYNX-1 trial and provides evidence of efficacy for this condition, which currently has no United States Food and Drug Administration-approved therapies.
“We believe this therapy could address a true unmet need and could offer meaningful benefits to keratorefractive patients experiencing glare, haloes, and reduced functional vision in low-light, low-contrast environments,” he said.
Opus Genetics Chief Medical Advisor Dr Jay Pepose said, “The positive results from the LYNX-2 trial reinforce the potential of phentolamine ophthalmic solution 0.75% as a first-in-class treatment for keratorefractive patients with vison disturbances under low-light conditions”.
Reference
- Opus Genetics, 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 (media release, 2 June 2025) available at: 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 [accessed 10 June 2025].
