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Opus Genetics Inc. (IRD+16.10%) has filed its annual report on Form 10-K filing for the fiscal year ended December 31, 2024.
The filing outlines the company's focus on developing gene therapies for inherited retinal diseases (IRDs) and other ophthalmic disorders. Opus Genetics has expanded its pipeline following the acquisition of a private corporation, Opus Genetics Inc., in October 2024.
The company's most advanced program, OPGx-LCA5, targets mutations in the LCA5 gene associated with Leber congenital amaurosis. A Phase 1/2 clinical trial is underway, with promising early results showing visual improvements in adult patients.
Another candidate, OPGx-BEST1, is being developed for IRDs related to mutations in the BEST1 gene. Preclinical studies have shown positive results in a canine model, with a Phase 1/2 study expected to begin by early 2026.
Opus Genetics also has a non-gene therapy candidate, Phentolamine Ophthalmic Solution 0.75%, approved by the FDA for treating pharmacologically induced mydriasis under the brand name RYZUMVI. The product launched commercially in April 2024.
The company is seeking a strategic partner to advance the clinical development of APX3330, a small-molecule inhibitor for diabetic retinopathy, due to its capital requirements and developmental timelines.
Opus Genetics' strategy includes advancing gene therapy programs, maximizing the value of APX3330 through partnerships, and completing late-stage development of its Phentolamine Solution programs.
The filing also discusses various risks, including integration challenges from the Opus acquisition, the novel nature of gene therapies, and the need for substantial additional capital.
Opus Genetics has entered into several licensing agreements to support its pipeline, including those with the University of Pennsylvania and Iveric Bio, which provide rights to develop certain gene therapy products.
The company acknowledges its dependence on third-party manufacturers for drug supply and highlights the competitive landscape in the gene therapy and ophthalmic markets.
Opus Genetics employs 18 full-time staff and relies on external consultants and contract organizations to support its operations.
This content was summarized by generative artificial intelligence using public filings retrieved from SEC.gov. The original data was derived from the Opus Genetics Inc. annual 10-K report dated March 31, 2025. To report an error, please email earnings@qz.com.