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Mar 31, 2021
Ocuphire Q1 2021 Earnings Report
Ocuphire reported positive data in a Phase 3 trial for Nyxol eye drops and advanced towards NDA submission.
Key Takeaways
Ocuphire Pharma announced positive top-line results from the pivotal MIRA-2 Phase 3 trial for Nyxol eye drops in reversal of mydriasis. The company also initiated multiple Phase 2 and 3 clinical trials and is progressing with its second product candidate, APX3330, in Diabetic Retinopathy.
Reported positive top-line results from the pivotal MIRA-2 Phase 3 trial for Nyxol eye drops in reversal of mydriasis.
Initiated ZETA-1 Phase 2 trial for APX3330 in Diabetic Retinopathy and Diabetic Macular Edema.
Initiated Phase 2 VEGA-1 trial evaluating Nyxol and low-dose pilocarpine in Presbyopia.
Presented positive pre-clinical data supporting APX3330's efficacy at the ARVO virtual Annual Meeting.
Ocuphire
Ocuphire
Forward Guidance
Ocuphire anticipates several milestones including top-line data readouts for Presbyopia and Night Vision Disturbances trials, presentation of Phase 3 MIRA-2 results, initiation of a second Phase 3 MIRA-3 trial, and completion of enrollment in the Phase 2 ZETA-1 trial.
Positive Outlook
- Top-line data expected end of Q2 2021 for Phase 2 VEGA-1 trial in Presbyopia
- Presenting Phase 3 MIRA-2 results at the ASCRS conference in July
- Top-line data expected end of Q3 2021 for Phase 3 LYNX-1 trial in Night Vision Disturbances
- Planning to initiate second Phase 3 MIRA-3 trial in 2H 2021 for Reversal of Mydriasis
- Completion of enrollment in Phase 2 ZETA-1 trial expected early 2022 for Diabetic Retinopathy and Diabetic Macular Edema
Challenges Ahead
- Success and timing of clinical trials are subject to regulatory submissions.
- Regulatory requirements or developments could impact trial progress.
- Changes to clinical trial designs and regulatory pathways may occur.
- The company may face challenges in obtaining sufficient additional capital.
- Legislative, regulatory, political, and economic developments could affect outcomes.