Ocuphire Pharma Results slide image

Ocuphire Pharma Results

Masked Safety Findings from Ongoing ZETA-1 Trial Favorable Safety Profile (as of 9/15/2022) Observed with 600 mg Oral Daily Doses in Diabetic Subjects 103 Subjects Enrolled 95 Subjects completed thru week 12 91 Subjects completed thru week 24 Ocuphire PHARMA 169 TEAES In 62/103 Subjects (60%) 30 Treatment-Related 18 Mild 12 Moderate¹ 0 Severe 3 withdrew due to an AE³ 6 lost to follow-up 149 Unrelated 92 Mild 48 Moderate 9 Severe 3 withdrew consent or site closure 0 Treatment- Related AEs involving liver, heart, kidney, brain, lung, or vital signs 16 SAES in 12/103 Subjects 0 Treatment Related 16 Unrelated² >7900 Subject-Days of Treatment at 600 mg/day APX3330 Exposure Oral APX3330 safety profile consistent with that seen in prior trials 1. 12 events in 8 subjects: diarrhea, worsening DME (OD and OS), pruritis, urticaria, blurry vision, decrease in hemoglobin level, ischemic diabetic maculopathy and central vision scotoma (in same subject), photophobia (OD and OS) and hypoaesthesia (in same subject) 2. Cellulitis (2 events in same subject), dyskinesia, transient ischemic event, COVID-19 and acute respiratory failure (same subject), progression of multivessel coronary artery disease, cholelithiasis, osteomyelitis, vertigo, chest pain, infection of toe and ulcer of toe and embolism (3 events in same subject), multi-system organ failure, worsening bradycardia 3. DME, Dyspnea, Pre-Syncope. Note: ZETA-1 Interim Data as of database 9/15/22 with monitoring to be completed before final database lock; assumes 50% subjects on APX3330 49
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