Ocuphire Pharma to Present at Euretina and Retina Society Conferences in October
Ocuphire Pharma announces presentations on APX3330 trial results at upcoming conferences
Positive
Results from the ZETA-1 Phase 2 Trial of APX3330 will be presented at the 23rd Euretina Congress and the 56th Annual Retina Society Scientific Meeting
10/06/2023 - 08:00 AM
Presentations Will Feature Data From ZETA-1 Phase 2 Trial of APX3330 in Diabetic Retinopathy
FARMINGTON HILLS, Mich., Oct. 06, 2023 (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 retinal and refractive eye disorders, today announced presentations featuring results from the ZETA-1 Phase 2 Trial of APX3330 at the 23 rd Euretina Congress to take place October 5-8, 2023 in Amsterdam, Netherlands and at the 56th Annual Retina Society Scientific Meeting to take place October 11-14, 2023 in New York, NY.
23 rd Euretina Congress
Title: Oral APX3330 Reduces the DRSS Worsening After 24-weeks of Daily Treatment: Efficacy and Safety Results of the ZETA-1 Phase 2 Trial in Diabetic Retinopathy Presenting Author: Veeral Sheth, MD Session: Free Paper Session 14: Mixed II Date/Time: Saturday, October 7, 2023 at 3:55 PM CEST Location: Room E103/104, RAI Amsterdam Convention Center
56 th Annual Retina Society Scientific Meeting
Title: ZETA-1 Phase 2 Trial Safety and Tolerability Results for of APX3330: A Novel, Oral Ref-1 Inhibitor for the Treatment of Diabetic Retinopathy Presenting Author: Anat Lowenstein, MD Session: Diabetic Retinopathy Date/Time: Friday, October 13, 2023 at 2:59 PM ET Location: Grand Ballroom, Intercontinental New York Barclay
About Ocuphire Pharma
Ocuphire Pharma, Inc. is a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders.
Ocuphire’s lead retinal product candidate, APX3330, is a first-in-class small-molecule inhibitor of Ref-1 (reduction oxidation effector factor-1 protein). Ref-1 is a regulator of transcription factors such as HIF-1a and NF-kB. Inhibiting REF-1 reduces levels of vascular endothelial growth factor (“VEGF”) and inflammatory cytokines which are known to play key roles in ocular angiogenesis and inflammation. Through inhibition of Ref-1, APX3330 normalizes the levels of VEGF to physiologic levels, unlike biologics that abolish the VEGF levels required for normal function. APX3330 is an oral tablet administered twice per day for the treatment of diabetic retinopathy (“DR”) and diabetic macular edema (“DME”). A Phase 2 study in subjects with DR or DME has recently been completed, and an End-of-Phase 2 meeting is confirmed with the U.S. Food and Drug Administration (“FDA”) in Q4 2023.
DR affects approximately 10 million people with diabetes and is projected to impact 14.6 million Americans by 2050. DR is classified as Non-Proliferative Diabetic Retinopathy (“NPDR”), the early stage of the disease in which symptoms may be mild or nonexistent or Proliferative Diabetic Retinopathy (“PDR”) which is the more advanced stage of diabetic eye disease that can be highly symptomatic with loss of vision. Approximately 80% 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% of NPDR patients currently receive no course of treatment apart from observation by their eye care specialist until they develop sight-threatening complications. This is due to the burdensome and frequent eye injections currently required with currently approved therapies for this disease. APX3330 as an oral tablet has the potential to be an early, non-invasive treatment for the 8 million NPDR patients in the US. Treatment with APX3330 is expected to delay or prevent progression of NPDR, thereby reducing the need for expensive intravitreal injections with anti-VEGF therapies and reducing the likelihood of vision loss due to DR.
Ocuphire has also in-licensed APX2009 and APX2014, which are second-generation analogs of APX3330. The unique dual mechanism of action of these Ref-1 inhibitors of reducing angiogenesis and inflammation could potentially be beneficial in treating other retinal diseases such as age-related macular degeneration (“AMD”), and geographic atrophy (“GA”). Ocuphire is currently evaluating local delivery routes in addition to the systemic (oral) route as part of its pipeline expansion in retinal therapies.
Ocuphire has a partnership with Viatris, Inc. to develop and commercialize phentolamine ophthalmic solution. Phentolamine is a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size by uniquely blocking the alpha-1 receptors found on the iris dilator muscle without affecting the ciliary muscle. In September 2023, the FDA approved RYZUMVI™ (phentolamine ophthalmic solution) 0.75% to treat pharmacologically induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents. Phentolamine is also in Phase 3 clinical development for the treatment of presbyopia and dim light (night) vision disturbances.
For more information, visit www.ocuphire.com
Contacts
What is the focus of Ocuphire Pharma?
Ocuphire Pharma is focused on developing and commercializing small-molecule therapies for retinal and refractive eye disorders.
Where will the presentations take place?
The presentations will take place at the 23rd Euretina Congress in Amsterdam, Netherlands and the 56th Annual Retina Society Scientific Meeting in New York, NY.
What are the titles of the presentations?
The titles of the presentations are 'Oral APX3330 Reduces the DRSS Worsening After 24-weeks of Daily Treatment: Efficacy and Safety Results of the ZETA-1 Phase 2 Trial in Diabetic Retinopathy' and 'ZETA-1 Phase 2 Trial Safety and Tolerability Results for of APX3330: A Novel, Oral Ref-1 Inhibitor for the Treatment of Diabetic Retinopathy'.
OCUP Rankings
#1000 Ranked by Stock Gains
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Industry
Pharmaceutical Preparation Manufacturing
Sector
Manufacturing
Tags
Health Technology, Biotechnology, Pharmaceuticals: Major, Manufacturing, Pharmaceutical Preparation Manufacturing
Country
US
City
Rockville
About OCUP
ocuphire is a new biopharmaceuticals company focused on developing and commercializing small molecule drugs for unmet medical needs in the ocular disease space. ocuphire’s lead drug candidate, nyxol eye drops, is aimed to treat patients with night vision disturbances (nvd), glaucoma and presbyopia (impaired near-term vision). ocuphire is in discussions with a prospective late stage ophthalmic drug program that could be developed in parallel. ocuphire's management team has over 100 years of drug development expertise across a diverse set of therapeutic areas including ophthalmology, orphan, cardio-metabolic, nephrology, oncology and respiratory.