Opus Genetics announced positive Phase 3 results for its Phentolamine Ophthalmic Solution 0.75% in patients with dim light disturbances, particularly those who have undergone keratorefractive surgery like LASIK. The LYNX-1 study showed statistically significant improvement in mesopic low contrast distance visual acuity (mLCVA) at Day 8 and Day 15 compared to placebo. Furthermore, patients reported significant reductions in glare, halos, and starbursts.
These findings are crucial for patients who experience debilitating visual disturbances after keratorefractive surgery, impacting their quality of life and potentially increasing the risk of motor vehicle accidents. A successful treatment could address a significant unmet medical need for this patient population and offer a substantial market opportunity. The positive results also validate the rationale for the ongoing LYNX-2 Phase 3 trial, which focuses on keratorefractive patients with similar visual impairments.
The LYNX-1 trial showed that 13% of participants treated with Phentolamine achieved a 15-letter or greater improvement in mLCVA at Day 8, increasing to 21% at Day 15, compared to 3% in the placebo group at both time points. In the post-LASIK subgroup, improvements were even more pronounced, with 29% showing improvement at Day 8 and 21% at Day 15, compared to 9% and 0% in the placebo group, respectively.
The promising results from the LYNX-1 study and the ongoing LYNX-2 trial position Phentolamine as a potential first-in-class treatment for dim light disturbances following keratorefractive surgery. Positive results from LYNX-2, expected mid-2025, could pave the way for regulatory submission and potential market entry, offering a much-needed solution for patients and significantly impacting Opus Genetics’ growth.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
