Feature Details Company Milestones and 2025 Catalysts Across Gene Therapy and Ophthalmic Programs

NEW YORK, April 15, 2025 (GLOBE NEWSWIRE) -- PRISM MarketView today published a Q&A feature with Dr. George Magrath, Chief Executive Officer of Opus Genetics, Inc. (“Opus Genetics” or the “Company”) (Nasdaq: IRD), a clinical-stage gene therapy company developing treatments for inherited retinal diseases (IRDs) and broader ophthalmic conditions.

Dr. George Magrath, Chief Executive Officer of Opus Genetics, Inc.

In the interview, Dr. Magrath outlines Opus Genetics’ recent milestones, including:

• Completion of enrollment in two Phase 3 clinical trials: VEGA-3 for presbyopia and LYNX-2 for post-LASIK night vision disturbances;
• FDA Fast Track designation for phentolamine ophthalmic solution to treat chronic night driving impairment; and
• Upcoming data presentations for OPGx-LCA5, an AAV-based gene therapy targeting Leber congenital amaurosis 5.
  

The feature also explores Opus Genetics’ strategy to seek to build a repeatable gene therapy platform and anticipated clinical milestones throughout 2025.

“With multiple regulatory milestones and clinical readouts, as well as an expanding pipeline, 2025 has the potential to be a pivotal year for Opus Genetics,” said Dr. Magrath.

The full Q&A, published by PRISM MarketView, is available here: https://prismmarketview.com/opus-genetics-advancing-gene-therapy-and-ophthalmic-innovation-with-major-milestones-ahead/

About Opus Genetics

Opus Genetics is a clinical-stage ophthalmic biopharmaceutical company developing therapies to treat patients with IRDs and other treatments for ophthalmic disorders. Our pipeline includes adeno-associated virus (AAV)-based investigational gene therapies that address mutations in genes that cause different forms of bestrophinopathy, Leber congenital amaurosis (LCA) and retinitis pigmentosa. Our most advanced investigational gene therapy program is designed to address mutations in the LCA5 gene, which encodes the lebercilin protein and is currently being evaluated in a Phase 1/2 open-label, dose-escalation trial, with encouraging early data. Our pipeline also includes BEST1 investigational gene therapy, designed to address mutations in the BEST1 gene, which is associated with retinal degeneration. The pipeline also includes Phentolamine Ophthalmic Solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist being investigated to reduce pupil size, and APX3330, a novel small-molecule inhibitor of Ref-1 being investigated to slow the progression of non-proliferative diabetic retinopathy. Phentolamine Ophthalmic Solution 0.75% is currently being evaluated in Phase 3 trials for presbyopia and dim (mesopic) light vision disturbances. We have reached agreement with the FDA under SPA for a Phase 3 trial to evaluate oral APX3330 for the treatment of DR more information, please visit www.opusgtx.com.

Forward-Looking Statements

This article contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements concerning data from and future enrollment for the Company’s clinical trials, the results of the Company’s ongoing Phase 1/2 trial with respect to OPGx LCA5, and the Company’s pipeline of additional indications.

These forward-looking statements relate to the Company, its business prospects and its results of operations and are subject to certain risks and uncertainties posed by many factors and events that could cause its actual business, prospects and results of operations to differ materially from those anticipated by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those described under Part II, Item 1A, “Risk Factors”, in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in the Company’s other filings with the U.S. Securities and Exchange Commission (the “SEC”). Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this article. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “aim,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The Company undertakes no obligation to revise any forward-looking statements in order to reflect events or circumstances that might subsequently arise, except as may be required by applicable law.

These forward-looking statements are based upon the Company’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation:

• Failure to successfully integrate our businesses with former Opus Genetics Inc. could have a material adverse effect on our business, financial condition and results of operations;
• The acquisition of former Opus Genetics Inc. significantly expanded our product pipeline and business operations and shifted our business strategies, which may not improve the value of our common stock;
• Our gene therapy product candidates are based on a novel technology that is difficult to develop and manufacture, which may result in delays and difficulties in obtaining regulatory approval;
• Our planned clinical trials may face substantial delays, result in failure, or provide inconclusive or adverse results that may not satisfy FDA requirements to further develop our therapeutic products;
• Changes in regulatory requirements could result in increased costs or delays in development timelines;
• We depend heavily on the success of our product pipeline; if we fail to find strategic partners or fail to adequately develop or commercialize our pipeline products, our business will be materially harmed;
• Others may discover, develop, or commercialize products similar to those in our pipeline before or more successfully than we do or develop generic variants of our products even while our product patents remain active, thereby reducing our market share and potential revenue from product sales;
• We do not currently have any sales or marketing infrastructure in place and we have limited drug research and discovery capabilities;
• The future commercial success of our products could significantly depend upon several uncertain factors, including third-party reimbursement practices and the existence of competitors with similar products;
• Product liability lawsuits against us or our suppliers or manufacturers could cause us to incur substantial liabilities and could limit commercialization of any product candidate that we may develop;
• Failure to comply with health and safety laws and regulations could lead to material fines ;
• We have not generated significant revenue from sales of any products and expect to incur losses for the foreseeable future;
• Our future viability is difficult to assess due to our short operating history and our future need for substantial additional capital, which could be limited by any adverse developments that affect the financial services industry;
• Raising additional capital may cause our stockholders to be diluted, among other adverse effects;
• We operate in a highly regulated industry and face many challenges complying to sudden changes in legislative reform or the regulatory environment, which affects our pipeline stability and could impair our ability to compete in international markets;
• We may not receive regulatory approval to market our developed product candidates within or outside of the U.S.;
• With respect to any of our product candidates that receive marketing approval, we may be subject to substantial penalties if we fail to comply with applicable regulatory requirements;
• Our potential relationships with healthcare providers and third-party payors will be subject to certain healthcare laws and regulations, which could expose us to extensive potential liabilities;
• We rely on third parties for material aspects of our business, such as conducting our nonclinical and clinical trials and supplying and manufacturing bulk drug substances, which exposes us to certain risks;
• We may be unsuccessful in entering into or maintaining licensing arrangements (such as the Viatris License Agreement) or establishing strategic alliances on favorable terms, which could harm our business;
• Our current focus on the cash-pay utilization for future sales of RYZUMVI may limit our ability to increase sales or achieve profitability with this product;
• Inadequate patent protection for our product candidates may result in our competitors developing similar or identical products or technology, which would adversely affect our ability to successfully commercialize;
• We may be unable to obtain full protection for our intellectual property rights under U.S. or foreign laws;
• We may become involved in lawsuits for a variety of reasons associated with our intellectual property rights, including alleged infringement suits initiated by third parties;
• We are dependent on our key personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy;
• As we grow, we may not be able to operate internationally or adequately develop and expand our sales, marketing, distribution, and other corporate functions, which could disrupt our operations;
• The market price of our common stock is expected to be volatile and subject to certain dilutive risks associated with our Equity Line of Credit arrangement; and
• Factors out of our control related to our securities, such as securities litigation or actions of activist stockholders, could adversely affect our business and stock price and cause us to incur significant expenses.

The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive. Readers are urged to carefully review and consider the various disclosures made by the Company in this statement and in the Company’s other reports filed with the SEC that advise interested parties of the risks and factors that may affect the Company’s business. All forward-looking statements contained in this article speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by applicable law.

About PRISM MarketView
PRISM MarketView is a financial media platform focused on highlighting emerging growth companies and breakthrough innovation across public markets. Through original editorial, video features, and executive Q&A content, PRISM delivers timely insights and elevates visibility for high-potential companies. PRISM also maintains a suite of proprietary indexes tracking momentum across sectors including biotech, AI, and consumer tech. Learn more at www.prismmarketview.com.

PRISM MarketView does not provide investment advice.

Disclaimer
This communication was produced by PRISM MarketView, an affiliate of PCG Advisory Inc., (together "PCG"). PCG is not a registered or licensed broker-dealer nor investment adviser. No information contained in this communication constitutes an offer to sell, a solicitation of an offer to buy, or a recommendation of any security. PCG may be compensated by respective clients for publicizing information relating to its clients’ securities. See www.pcgadvisory.com/disclosures.

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