Nyxol® Eye Drops Potentially Offer Differentiated Mechanism of Action to Treat Age-Related Blurry Near Vision
Launch of Presbyopia Phase 3 Program Supported by Positive Clinical Results that Demonstrated Durable Efficacy and Favorable Safety Profile
“2023 promises to be a pivotal year for executing our comprehensive Phase 3 program in presbyopia,” said
VEGA-2 Phase 3 Pivotal Trial Design
VEGA-2 is a randomized, double-masked, placebo-controlled, multi-center, Phase 3 study to evaluate Nyxol (phentolamine ophthalmic solution 0.75%) as a single agent and with adjunctive low-dose pilocarpine (LDP) 0.4% in 320 subjects with presbyopia. The study will be conducted in 2 stages. Stage 1 has two treatment groups (Nyxol or placebo), with approximately 160 subjects in each group. Stage 2 will have four treatment groups (Nyxol + LDP, Nyxol + LDP vehicle, placebo + LDP, and placebo + LDP vehicle), with approximately 80 subjects per treatment group. Subjects will be recruited from upto 30 investigational sites in the US. For more information on the trial design and endpoints, please refer to www.ClinicalTrials.gov Identifier NCT05646719.
In addition to VEGA-2 trial, Ocuphire plans to initiate a second Phase 3 pivotal trial in presbyopia (VEGA-3), and a one-year safety study (LYRA-1) in 2023.
About Presbyopia
Presbyopia is characterized as age-related blurred near vision, with onset most common in people over 40 years old. As the eye ages, the lens becomes stiffer, which limits the eye’s ability to adjust its focus for reading or for other tasks that require clear vision at near distances. Presbyopia patients experience blurred near vision, difficulty seeing in dim light, and eye strain. Because of the ubiquity of the condition, presbyopia represents a large market both in
About
Ocuphire is a publicly traded (Nasdaq: OCUP), clinical-stage, ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of refractive and retinal eye disorders.
The Company has a partnership with FamyGen Life Sciences and
The Company’s late-stage product candidate APX3330 is an oral tablet designed to inhibit angiogenesis and inflammation pathways relevant to retinal and choroidal vascular diseases, such as diabetic retinopathy (DR) and diabetic macular edema (DME). DR affects over 8 million diabetics in the US and is a large unmet need with limited treatment options. APX3330 has been studied in 11 Phase 1 and 2 trials. The Company announced the completion of last patient last visit in late August with top-line results expected in early 2023 (NCT04692688).
For more information, visit www.ocuphire.com
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “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 initiation of clinical trials, receipt of data from clinical trials, submission and receipt of regulatory approvals, Ocuphire’s business strategy and potential growth, and timelines. 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: (i) the success and timing of regulatory submissions and pre-clinical and clinical trials, including enrollment and data readouts; (ii) regulatory requirements or developments; (iii) changes to clinical trial designs and regulatory pathways; (iv) changes in capital resource requirements; (v) risks related to the inability of Ocuphire to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs; (vi) legislative, regulatory, political and economic developments, (vii) changes in market opportunities, (viii) the effects of COVID-19 on clinical programs and business operations, (ix) risks that the partnerships with Famy and
Contacts
Corporate | Investor Relations | |
CEO & Founder ir@ocuphire.com | LifeSci Advisors cdavis@lifesciadvisors.com | Bret Shapiro CoreIR brets@coreir.com |
Source:
2023 GlobeNewswire, Inc., source