S&P 500 eases slightly from fresh record high after stronger economic growth
RESEARCH TRIANGLE PARK, N.C. - Opus Genetics, Inc. (NASDAQ:IRD), a $45 million market cap biotech company with $13.65 million in trailing twelve-month revenue, announced positive results from its Phase 3 LYNX-2 clinical trial for Phentolamine Ophthalmic Solution 0.75%, aimed at treating chronic night driving impairment in patients with reduced mesopic vision following keratorefractive surgery. The study met its primary endpoint with a significant number of patients achieving improved low-light vision. According to InvestingPro data, the company maintains a strong liquidity position with more cash than debt on its balance sheet.
The trial included 199 participants who had previously undergone eye surgery and reported decreased visual acuity under low-light conditions. Participants were randomized to receive either the Phentolamine treatment or a placebo, administered nightly over a six-week period. Results showed that 17.3% of patients treated with Phentolamine achieved a gain of 15 letters or more in visual acuity, compared to 9.2% in the placebo group.
Patients also reported improvements in night driving, particularly in their ability to see the road despite oncoming headlights and in low-contrast conditions at dawn or dusk. These benefits were quantified using the Vision and Night Driving Questionnaire (VND-Q), with statistically significant improvements noted in the Phentolamine group.
The safety profile of Phentolamine Ophthalmic Solution 0.75% was consistent with previous studies, with no new safety concerns identified. Additionally, there was no evidence of tachyphylaxis, or diminishing response to the treatment, over the six-week dosing period.
This study was conducted under a Special Protocol Assessment (SPA) agreement with the U.S. FDA, which also granted Phentolamine Ophthalmic Solution 0.75% Fast Track designation for the treatment of night driving impairment in keratorefractive patients. Despite current challenges with profitability, InvestingPro analysis shows strong analyst confidence in the company’s potential, with a consensus recommendation of 1.33 (Strong Buy). Discover more insights and 6 additional ProTips with an InvestingPro subscription.
Opus Genetics is engaged in a global licensing agreement with Viatris, which grants Viatris exclusive rights to commercialize the solution in the U.S. The company continues to monitor the long-term safety of LYNX-2 patients over a 48-week period.
The successful trial positions Phentolamine Ophthalmic Solution 0.75% as a potential first-in-class treatment for patients experiencing vision disturbances under low-light conditions post-surgery, a condition currently without FDA-approved therapies. Further details on the study can be found on ClinicalTrials.gov (NCT06349759).
This information is based on a press release statement from Opus Genetics, Inc.
In other recent news, Opus Genetics has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. FDA for its investigational gene therapy, OPGx-LCA5, aimed at treating Leber Congenital Amaurosis. The designation is based on promising preliminary clinical data from an ongoing Phase 1/2 trial. Additionally, Opus Genetics has reported encouraging early results from the first pediatric patient in this trial, noting a significant improvement in visual function. The company held its annual stockholder meeting, where shareholders approved several key proposals, including the election of nine directors and the conversion of Series A Preferred Stock into Common Stock.
Furthermore, Craig-Hallum has initiated coverage of Opus Genetics with a Buy rating and a $6 price target, citing the potential of its gene therapy pipeline. H.C. Wainwright also maintained its Buy rating with an $8 price target, highlighting upcoming presentations and data releases that are expected to impact the company’s clinical strategies. Opus Genetics is preparing for the Phase 1/2 development of another gene therapy candidate, OPGx-BEST1, with trials scheduled to begin in 2025. These developments reflect the company’s ongoing efforts in advancing its gene therapy treatments for inherited retinal diseases.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.