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DURHAM, N.C. - Opus Genetics, Inc. (NASDAQ:IRD), a $33 million market cap biotech firm specializing in ophthalmic disorders, has recently completed enrollment for its VEGA-3 Phase 3 trial, which tests Phentolamine Ophthalmic Solution 0.75% against presbyopia. According to InvestingPro data, the company maintains a strong balance sheet with more cash than debt, though it reported -$29.47 million in EBITDA for the last twelve months. Concurrently, the company is progressing with its LYNX-2 Phase 3 trial, targeting enrollment completion in the first half of 2025, to address night driving impairment in keratorefractive surgery patients.
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Phentolamine Ophthalmic Solution 0.75% to expedite the development and review process for this treatment. This status is awarded to drugs that show potential in treating serious conditions with unmet medical needs. Wall Street appears optimistic about the company’s prospects, with InvestingPro analysis showing a highly favorable analyst consensus rating of 1.25, suggesting strong buy recommendations. Discover more detailed analyst insights and 8 additional ProTips with an InvestingPro subscription.
VEGA-3 is a randomized, double-masked, placebo-controlled trial involving 545 participants across 39 U.S. sites, focusing on improving near vision without affecting nighttime distance vision. The primary measure is a 15-letter improvement in near visual acuity eight days after the first treatment, with participants followed for 48 weeks to assess long-term safety.
The LYNX-2 trial, with more than 95% of its 200-subject target enrolled, aims to improve low-light vision in patients who have undergone keratorefractive surgery. The primary endpoint is a 15-letter improvement in low contrast distance vision after 15 days of dosing. This trial is conducted under a Special Protocol Assessment with the FDA.
Phentolamine Ophthalmic Solution 0.75% is being developed as a non-invasive alternative to traditional corrective measures for presbyopia, a condition affecting over 128 million Americans and 2 billion people globally. It also aims to address decreased vision in low light conditions post-keratorefractive surgery, a currently unmet medical need with no FDA-approved treatments.
Opus Genetics is advancing a pipeline of gene therapies for inherited retinal diseases and other ophthalmic disorders, including its late-stage product candidate, Phentolamine Ophthalmic Solution 0.75%, and APX3330, a novel small-molecule inhibitor. The company maintains strong liquidity with a current ratio of 6.63, providing adequate resources for its development programs. According to InvestingPro’s Fair Value analysis, the stock currently appears undervalued, presenting a potential opportunity for investors interested in the biotech sector.
The information in this article is based on a press release statement from Opus Genetics, Inc.
In other recent news, Opus Genetics has announced the establishment of a $40 million at-the-market equity issuance program. The funds raised will be used for general corporate purposes, including advancing product candidates and funding clinical trials. The company has entered into a sales agreement with Leerink Partners LLC for this program. Additionally, Opus Genetics has aligned with the FDA on a Special Protocol Assessment for a Phase 3 trial of APX3330, a treatment for diabetic retinopathy. This agreement confirms the trial’s design and primary endpoint, which could lead to a New Drug Application if results are positive.
Opus Genetics has also dosed the first pediatric patient in a Phase 1/2 clinical trial for a gene therapy targeting Leber congenital amaurosis. Initial data from this trial is expected by the third quarter of 2025. The company is continuing to develop its pipeline, including a BEST1 gene therapy expected to enter Phase 1/2 trials in 2025. In governance-related news, Opus Genetics has revised its executive compensation agreements, enhancing severance terms for its CEO and CFO. The company has also set April 30, 2025, for its Annual Meeting of Stockholders, with guidelines for stockholder proposals and nominations now available.
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