Ocuphire Pharma reports Q3 EPS 25c, consensus (22c)

Reports Q3 revenue $11.9M, consensus $3.02M. “We achieved important regulatory and clinical milestones in recent months, particularly in advancing oral APX3330 towards a registrational Phase 3 program in diabetic retinopathy,” said Chief Executive Officer George Magrath, M.D., M.B.A., M.S., “We now have agreement with the FDA on the Phase 3 primary endpoint of 3-step worsening on a binocular Diabetic Retinopathy Severity Scale, and plan to finalize the protocol and statistical analysis plan with the FDA through a Special Protocol Assessment submission. If approved, APX3330 has the potential to be the first non-invasive, early treatment to delay or prevent vision-threatening complications in millions of patients with non-proliferative DR. We are very pleased to have recently received FDA approval of RYZUMVI 0.75% eye drops for the reversal of pharmacologically induced mydriasis and look forward to our partner Viatris’ commercial launch in the first half of 2024. We are also excited to share that the VEGA-2 Phase 3 trial in presbyopia met its primary endpoint, and Viatris is expected to continue the Phase 3 development in the first half of 2024.”