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Outlook Therapeutics (OTLK)
NASDAQ:OTLK
Bevacizumab, Ranibizumab
Age-Related Macular Degeneration, Neovascular Age-Related Macular Degeneration, Wet Macular Degeneration
Phase III
Completed
A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects with Neovascular Age-related Macular Degeneration (AMD)
Dec 19, 2023
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Bevacizumab
Diabetic Macular Edema, Neovascular Age-Related Macular Degeneration, Age-Related Macular Degeneration, Wet Macular Degeneration, Brvo - Branch Retinal Vein Occlusion
Phase III
Active Not Recruiting
A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders
Oct 28, 2021
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Bevacizumab
Diabetic Macular Edema, Age-Related Macular Degeneration, Neovascular Age-Related Macular Degeneration, Wet Macular Degeneration, Brvo - Branch Retinal Vein Occlusion
Phase III
Completed
A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders
Aug 13, 2020
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Bevacizumab, Ranibizumab
Age-Related Macular Degeneration, Neovascular Age-Related Macular Degeneration, Wet Macular Degeneration
Phase III
Completed
A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
Feb 14, 2019
―
Bevacizumab, Ranibizumab
Age-Related Macular Degeneration, Neovascular Age-Related Macular Degeneration, Wet Macular Degeneration
Phase III
Completed
A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
Feb 06, 2019
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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 Outlook Therapeutics (OTLK) have in its pipeline
OTLK is currently developing the following drugs: Bevacizumab, Ranibizumab, Bevacizumab, Bevacizumab. These drug candidates are in various stages of clinical development as the company works toward FDA approval.