Benzinga | Nov 1, 2021 09:32AM EDT

Ocuphire Invited To Present Clinical Data On Nyxol And APX3330 At American Academy Of Ophthalmology 2021 Annual Meeting And Eyecelerator/AAO Meeting

Ocuphire Pharma, Inc. (NASDAQ:OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of several eye disorders, today announced that clinical data on its therapeutic candidates Nyxol(r) and APX3330 will be featured in poster sessions as presentations at the upcoming American Academy of Ophthalmology (AAO) 2021 annual meeting to take place in New Orleans, November 12 -- 15. In addition, Ocuphire will present at the Eyecelerator@AAO 2021 satellite symposium on November 11.

"We are delighted to see the early US regulatory approval of Allergan's eye drops, the first pharmaceutical therapy to be approved for the treatment of presbyopia," said Mina Sooch, President & CEO of Ocuphire. "Presbyopia represents an area of significant growth and market opportunity with over 120 million Americans living with presbyopia and dependent on reading glasses. Based upon our positive Phase 2 study results reported this year, we believe that Nyxol and low dose pilocarpine (LDP) represents a novel mechanism of action with a differentiated safety, efficacy, and durability profile. We plan to initiate our Phase 3 trials for presbyopia in the first half of 2022. We believe that Nyxol's clinical profile holds the potential as a best-in-class therapy for the treatment of presbyopia."

AAO 2021 Subspecialty Day Presentation Details

Title: Favorable Safety and Tolerability Profile of Oral APX3330 Drives Dosing Strategy for Ongoing Phase 2 Trial for DR/DMESubspecialty Retina, Friday and Saturday, November 12-13, 2021Day:Abstract#: PO332 (link)Presenting Michael J. Allingham, MD, PhDauthor:

Dr. Allingham will present safety data on oral APX3330 from over 300 healthy volunteers and patients with chronic hepatitis across five Phase 1 and five Phase 2 clinical trials at doses up to 600 mg/day. A sixth Phase 1 study will also be presented, showing safety data from 19 patients with solid tumors who were treated with daily oral dosing of APX3330 of up to 720 mg/day. Additional preclinical data on MOA in normal cells and PK exposure data will be presented. The aggregate clinical data from these 11 completed trials support Ocuphire's ZETA-1 Phase 2b study, an ongoing, randomized, double-masked, placebo-controlled trial evaluating the safety and efficacy of oral APX3330 in the treatment of diabetic retinopathy (DR) and diabetic macular edema (DME). Additional information about the ZETA-1 Phase 2b trial can be found at www.clinicaltrials.gov (NCT04692688).



Phase 2 Clinical Trial to Evaluate theTitle: Efficacy of Phentolamine Ophthalmic Solution and Low-Dose Pilocarpine for the Treatment of PresbyopiaSubspecialty Refractive Surgery,Day: Friday and Saturday, November 12-13, 2021Abstract #: 30068457 (link)Presenting Jay S. Pepose, MD, PhDAuthor:

Dr. Pepose will present results from the VEGA-1 Phase 2 multi-center, randomized, placebo-controlled, double-masked clinical trial which evaluated a kit combination of Nyxol, 0.75% phentolamine ophthalmic solution (POS), plus low-dose 0.4% pilocarpine (LDP) for the treatment of presbyopia. Ocuphire reported top line positive data from VEGA-1 earlier this year. The VEGA-1 study enrolled 150 presbyopic patients at 17 investigational sites in the US. On the primary endpoint, 61% of subjects treated with Nyxol + LDP improved 15 letters or greater (? 3 lines) in photopic binocular near vision at 1 hour compared with 28% of subjects on placebo (33% placebo adjusted difference; p= 0.003). Treatment with Nyxol and/or LDP did not reduce best corrected distance vision. Moreover, Nyxol and/or LDP was well tolerated with no headaches and had a durable effect measured up to 6 hours. Additional information about the VEGA-1 Phase 2 trial can be found at www.clinicaltrials.gov (NCT04675151).



Eyecelerator@AAO 2021

Company Showcase: Retina, Cornea, Glaucoma & Anterior SegmentSession Room: Glaucoma & Anterior SegmentTime: 11:30am Central US / 12:30pm Eastern USDate: November 11, 2021Presenter Mina Sooch, M.B.A., CEO Ocuphire

Eyecelerator is a partnership between the American Academy of Ophthalmology and American Society of Cataract and Refractive Surgery (ASCRS) to accelerate ophthalmic innovation through next-generation business conferences and platforms. Ocuphire is part of a lineup of more than 30 companies, from startups to public, who will present innovations at all stages. The format will be five-minute company presentations followed by a moderated Q+A with panels of seasoned pharma executive, investors, and KOLs. Ocuphire will be one of two companies presenting clinical data for Presbyopia at the meeting. For more details, please visit https://www.eyecelerator.com