Ocuphire’s VEGA-1 Phase 2 Trial in Presbyopia Meets Primary and Secondary Endpoints

Met primary endpoint with statistical significance at 1 hour with 61% of subjects treated with Nyxol® plus low-dose pilocarpine (LDP) gaining ≥ 15 letters (3 lines) in near vision

Key secondary endpoints on visual acuity and pupil diameter showed statistical significance

Nyxol plus LDP showed a favorable safety profile

Plans to advance into Phase 3 registration trials

Conference call and live webcast @ 8.30 am ET today

FARMINGTON HILLS, Mich., June 30, 2021 (GLOBE NEWSWIRE) -- 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 the VEGA-1 Phase 2 clinical trial evaluating the efficacy and safety of Nyxol in combination with low-dose pilocarpine (LDP) in presbyopic subjects successfully met its primary and many secondary endpoints. On the strength of these results, Ocuphire plans to move into Phase 3. Given the rapid onset and sustained duration of efficacy, the favorable safety profile, and the potential tunability of treatment, Nyxol + LDP has the potential for differentiation and to be a best in class product for the treatment of presbyopia.

Highlights from the VEGA-1 Phase 2 Trial in Presbyopia:

Nyxol + LDP Met 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 with statistical significance (p = 0.003 with placebo adjusted difference of 33%)

Nyxol + LDP Met Many Additional Efficacy Endpoints

• Met the Phase 3 co-primary endpoint vs. placebo gaining 15 letters (3 lines) near vision with less than 5 letters of distance vision loss
• Rapid onset of efficacy at 30 mins
• Durable near vision improvement through at least 6 hours
• Sustained significant reduction in pupil diameter over at least 18 hours due to the durable effects of Nyxol
• Near vision efficacy seen both monocularly and binocularly
• Efficacy in both light and dark iris colors

Nyxol + LDP Showed a Favorable Safety Profile

• No serious AEs, almost all AEs were mild
• No headaches, no brow aches, and no blurry vision AEs were reported
• Mild, transient conjunctival hyperemia (eye redness) observed in