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Opus Genetics (Nasdaq: IRD) announced significant developments for its Phentolamine Ophthalmic Solution 0.75% programs. The FDA granted Fast Track designation for treating chronic night driving impairment in keratorefractive patients with reduced mesopic vision. The company completed enrollment in the VEGA-3 Phase 3 trial for presbyopia, involving 545 participants across 39 U.S. sites.
The LYNX-2 Phase 3 trial, which is 95% enrolled with a target of 200 subjects, is expected to complete enrollment in H1 2025. This study evaluates the solution's effectiveness in treating visual loss in low light conditions post-keratorefractive surgery. The primary endpoint aims for a 3-line improvement in distance vision under low light conditions after 15 days.
The VEGA-3 trial's primary endpoint measures 15-letter improvement in photopic binocular distance-corrected near visual acuity on day eight, with participants being monitored for 48 weeks for safety data.
Opus Genetics (Nasdaq: IRD) has announced significant progress in its Phase 1/2 clinical trial for OPGx-LCA5, a gene therapy treatment for Leber congenital amaurosis (LCA). The company has successfully dosed its first pediatric patient and plans to share initial data from this cohort by Q3 2025.
The trial has already shown promising results in adult patients, with meaningful visual improvements observed as early as one month after treatment in the first three adult patients. New 12-month data on these adult patients will be presented at a major medical conference in Q2 2025.
An FDA Type D meeting is scheduled for March 2025 to discuss Phase 3 trial design and registrational endpoints. The ongoing Phase 1/2 trial evaluates safety and preliminary efficacy through multiple endpoints, including the Multi-Luminance orientation and Mobility Test, Full-Field Stimulus Testing, and microperimetry.
Opus Genetics (Nasdaq: IRD) has secured FDA agreement under Special Protocol Assessment (SPA) for its Phase 3 clinical trial of oral APX3330 in treating moderate to severe non-proliferative diabetic retinopathy (NPDR). The agreement confirms that the trial design and endpoints will support a New Drug Application submission.
The primary endpoint focuses on reducing 3-step or greater worsening on the binocular diabetic retinopathy severity scale compared to placebo. Previous Phase 2 ZETA-1 trial showed APX3330's potential to slow DR progression with a favorable safety profile. The company plans to seek partners for further development while focusing on gene therapy candidates for inherited retinal diseases.
Diabetic retinopathy affects approximately 10 million patients in the US and is the leading cause of blindness in working-age adults.
Opus Genetics (Nasdaq: IRD) will host a virtual key opinion leader (KOL) event on December 11, 2024, at 4:00 PM ET to present 6-month efficacy and safety data from its ongoing Phase 1/2 trial of OPGx-LCA5, a gene therapy for LCA5-associated inherited retinal disease.
The event will feature renowned experts including Jean Bennett, MD, PhD, Tomas Aleman, MD, Christine Kay, MD, and Arshad Khanani, MD, MA, FASRS. They will discuss patient-level data, unmet needs in LCA5-associated IRD, and future development steps.
Jean Bennett, MD, PhD, is an Emeritus Professor at the University of Pennsylvania and has extensive experience in gene therapy research. Tomas Aleman, MD, is a Research Professor at the same university with expertise in hereditary retinal degenerations. Christine Kay, MD, is a director at Vitreoretinal Associates, focusing on inherited retinal diseases. Arshad Khanani, MD, MA, FASRS, is the Managing Partner at Sierra Eye Associates and a Clinical Professor at the University of Nevada.
The event will conclude with a live Q&A session.
Opus Genetics reported Q3 2024 financial results following its October acquisition by Ocuphire Pharma. The combined company, now trading as IRD, has a pro forma cash balance of $37 million, expected to extend runway into 2026. Q3 revenue was $3.9 million, down from $11.9 million in Q3 2023. Net loss was $7.5 million ($0.29 per share) compared to net income of $5.6 million in Q3 2023. The company expects four clinical data readouts in 2025, including Phase 3 studies for Phentolamine Ophthalmic Solution and gene therapy trials.
Opus Genetics (Nasdaq: IRD) announced that its Board of Directors has approved an equity award for Dr. Benjamin Yerxa, Ph.D., the Company's newly appointed President, under the 2021 Inducement Plan. Dr. Yerxa received a time-based restricted stock unit award of 332,800 shares, which will vest in four equal annual installments from 2025 to 2028. Dr. Yerxa previously served as CEO and President of the predecessor company before its acquisition in October 2024. The award was approved in accordance with Nasdaq Listing Rule 5635(c)(4) as a material inducement to his employment, effective November 7, 2024.
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