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Opthea Limited (AU:OPT)
ASX:OPT
Sham, 2.0 Mg Opt-302, 2.0 Aflibercept
Neovascular Age-Related Macular Degeneration
Phase III
Terminated
OPT-302 With Aflibercept in Neovascular Age-related Macular Degeneration (nAMD)
Feb 12, 2021
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Sham, 2.0 Mg Opt-302, 0.5 Mg Ranibizumab
Neovascular Age-Related Macular Degeneration
Phase III
Terminated
OPT-302 With Ranibizumab in Neovascular Age-related Macular Degeneration (nAMD)
Feb 12, 2021
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Aflibercept, Opt-302, Sham Intravitreal Injection
Diabetic Macular Edema
Phase I/II
Completed
A Dose Ranging Study of OPT-302 With Aflibercept for Persistent Diabetic Macular Edema
Jan 01, 2018
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Ranibizumab, Opt-302, Sham Intravitreal Injection
Neovascular Age-Related Macular Degeneration
Phase II
Completed
A Dose Ranging Study of OPT-302 With Ranibizumab in Neovascular (Wet) AMD
Nov 14, 2017
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Opt-302, Lucentis™
Macular Degeneration, Retinal Diseases, Eye Diseases, Retinal Degeneration, Neovascularization, Pathologic
Phase I
Completed
Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of OPT-302 With or Without Lucentis™ in Patients With Wet AMD
Aug 25, 2015
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Opthea Limited (OPT) have in its pipeline
OPT is currently developing the following drugs: Sham, 2.0 Mg Opt-302, 2.0 Aflibercept, Sham, 2.0 Mg Opt-302, 0.5 Mg Ranibizumab, Aflibercept, Opt-302, Sham Intravitreal Injection. These drug candidates are in various stages of clinical development as the company works toward FDA approval.