Ocuphire Pharma to Highlight APX3330 for Diabetic Retinopathy at Two Scientific Meetings in July

CEO to participate in ARVO SIG panel on oral medications for retinal diseases

ZETA-1 Phase 2 clinical trial subset analysis to be presented during the ASRS 42^nd Annual Scientific Meeting

FARMINGTON HILLS, Mich., July 10, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of patients with retinal and refractive eye disorders, today announced it will participate in the Association for Research in Vision and Ophthalmology Special Interest Group (ARVO SIG) panel and the American Society of Retina Specialists (ASRS) 42^nd Annual Scientific Meeting, to highlight the potential of its lead oral candidate in development for diabetic retinopathy (DR).

APX3330 is an oral small-molecule inhibitor of Ref-1 (reduction oxidation effector factor-1 protein) being developed for the treatment of non-proliferative diabetic retinopathy (NPDR). DR affects approximately 10 million of the 38 million Americans with diabetes and is the leading cause of blindness in working-age adults.

Ocuphire’s Chief Executive Officer, George Magrath, M.D., M.B.A., M.S., will participate in an ARVO SIG panel discussion, “Oral Medications for the Management of Retinal Diseases,” to take place virtually on July 11 at 6 p.m. ET. The discussion will focus on the potential of oral medications in treating retinal diseases earlier in the disease process, the need to develop new therapies with differentiated mechanisms of action, and the challenges and opportunities associated with developing these oral medications. Following the virtual event, the panel will be available on-demand on ARVO’s website.

“Effect of Oral APX3330 on Progression of Non-Proliferative Diabetic Retinopathy Utilizing a Binocular DRSS Person-Level Scale,” presented by Kareem Sioufi, M.D., will be available as a virtual paper-on-demand as part of the ASRS 42^nd Annual Scientific Meeting. Co-authored by Dr. Magrath; Victor H. Gonzalez, M.D., FASRS; Daniel Su, M.D.; David M. Brown, M.D., FASRS; Jay S. Pepose, M.D., Ph.D.; Barbara Withers, Ph.D.; Kostas Charizanis, Ph.D.; and Mitchell G. Brigell, Ph.D., the subset analysis of Ocuphire’s ZETA-1 Phase 2 clinical trial evaluates the efficacy of APX3330 in slowing DR progression using a binocular DRSS person-level scale in high-risk NPDR patients. Beginning July 17, the paper will be available to ASRS attendees on the mobile app and at viewing stations/kiosks. Following the meeting, the paper will be available in ASRS’ member on-demand content library.

“I am looking forward to participating in the ARVO SIG panel session on oral medications for the management of retinal diseases and eager to have an engaging discussion on how non-invasive treatment options could address issues with patient compliance and treatment burden found with injectable therapies,” said Dr. Magrath. “In addition, we are pleased that Dr. Sioufi will present the ZETA-1 subset analysis during the prestigious ASRS 42^nd Annual Scientific Meeting. We believe oral APX3330 has the potential to change the treatment paradigm for diabetic retinopathy by simultaneously addressing angiogenesis, oxidative stress and inflammation, and are grateful to ARVO and ASRS for inclusion in the meeting programs.”

About APX3330

APX3330 is a novel small-molecule inhibitor of Ref-1 (reduction oxidation effector factor-1 protein). Ref-1 plays a crucial role in DNA repair and reduction-oxidation activities, and inhibition promotes retinal health by uniquely targeting three different, but related, disease processes implicated in a host of vision-threatening retinal diseases: inflammation, angiogenesis and oxidative stress. APX3330 is initially being developed as an oral tablet to be an early, non-invasive treatment to slow the progression of DR, thereby aiming to delay the start of treatment, which may include anti-VEGF injection treatments. Data from the completed ZETA-1 Phase 2 trial demonstrated that APX3330 has the potential to slow clinically meaningful progression of DR.

About Diabetic Retinopathy

Diabetic retinopathy (DR) affects approximately 10 million of the 38 million Americans with diabetes and is the leading cause of blindness in working-age adults. DR is projected to impact over 14 million Americans by 2050. DR is classified as either non-proliferative DR (NPDR), the early stage of the disease in which symptoms may be mild or non-existent, and proliferative (PDR), the more advanced stage of diabetic eye disease that can be highly symptomatic and is associated with loss of vision. Approximately 80 percent of DR patients have NPDR that will progress to PDR if left untreated. Despite the risk for visual loss associated with this disease, over 90 percent of NPDR patients currently receive no course of treatment apart from observation by their eye care specialist until they develop sight-threatening complications due to the treatment burden of the frequent eye injections required with currently approved DR therapies.

About Ocuphire Pharma

Ocuphire Pharma, Inc. (Nasdaq: OCUP) is a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing novel therapies for the treatment of patients with retinal and refractive eye disorders. Ocuphire’s lead product candidate, APX3330, a novel small-molecule inhibitor of Ref-1 (reduction oxidation effector factor-1 protein), is in development for diabetic retinopathy. In addition, Ocuphire’s late-stage partnered program Phentolamine Ophthalmic Solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size, is being developed for presbyopia and dim light vision disturbances (DLD) and is currently approved and marketed as RYZUMVI™ for reversal of pharmacologically induced mydriasis. For more information, please visit www.ocuphire.com. 

Forward Looking Statements

This press release 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 the efficacy of APX3330 in slowing the progression of diabetic retinopathy, the safety and tolerability of APX3330, ongoing discussions with the FDA regarding various of our drug products, and continued drug development under our partnership agreement.

These forward-looking statements relate to us, our business prospects and our results of operations and are subject to certain risks and uncertainties posed by many factors and events that could cause our 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 the heading “Risk Factors” included in our Annual Report on Form 10-K. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this report. 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. We undertake no obligation to revise any forward-looking statements in order to reflect events or circumstances that might subsequently arise.

These forward-looking statements are based upon Ocuphire’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:

• The success and timing of regulatory submissions and pre-clinical and clinical trials, including enrollment and data readouts;
• Regulatory requirements or developments;
• Changes to or unanticipated events in connection with clinical trial designs and regulatory pathways;
• Delays or difficulties in the enrollment of patients in clinical trials;
• Substantial competition and rapid technological change;
• Our development of sales and marketing infrastructure;
• Future revenue losses and profitability;
• Our relatively short operating history;
• Changes in capital resource requirements;
• Risks related to the inability of Ocuphire to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs;
• Domestic and worldwide legislative, regulatory, political and economic developments;
• Employee misconduct;
• Changes in market opportunities and acceptance;
• Reliance on third-parties;
• Future, potential product liability and securities litigation;
• System failures, unplanned events, or cyber incidents;
• The substantial number of shares subject to potential issuance associated with our equity line of credit arrangement;
• Risks that our partnership or other licensing arrangements, may not facilitate the commercialization or market acceptance of Ocuphire’s product candidates;
• Future fluctuations in the market price of our common stock;
• The success and timing of commercialization of any of Ocuphire’s product candidates; and
• Obtaining and maintaining Ocuphire’s intellectual property rights.
  

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 us in this report and in our other reports filed with the Securities and Exchange Commission that advise interested parties of the risks and factors that may affect our business. All forward-looking statements contained in this press release speak only as of the date on which they were made. Ocuphire undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

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Released July 10, 2024