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Ocugen Inc (OCGN)
NASDAQ:OCGN
Sub-Retinal Administration Of Ocu400-301
Retinitis Pigmentosa
Phase III
Recruiting
A Phase 3 Study Of OCU400 Gene Therapy for the Treatment Of Retinitis Pigmentosa
Apr 09, 2024
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Ocu410
Geographic Atrophy
Phase I/II
Active Not Recruiting
Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy
Jun 30, 2023
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Ocu410st
Stargardt Disease
Phase II/III
Recruiting
A Phase 2/3 Trial to Assess the Efficacy and Safety of OCU410ST for Stargardt Disease
Jun 30, 2023
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Ocu200
Diabetic Macular Edema, Center Involved Diabetic Macular Edema
Phase I
Recruiting
Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME)
Mar 27, 2023
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Ocu400 Low Dose, Ocu400 Med Dose, Ocu400 High Dose, Ocu400 Second Eye Dosing
Retinitis Pigmentosa, Leber Congenital Amaurosis
Phase I/II
Active Not Recruiting
Study to Assess the Safety and Efficacy of OCU400 for Retinitis Pigmentosa and Leber Congenital Amaurosis
Nov 16, 2021
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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 Ocugen Inc (OCGN) have in its pipeline
OCGN is currently developing the following drugs: Sub-Retinal Administration Of Ocu400-301, Ocu410, Ocu410st. These drug candidates are in various stages of clinical development as the company works toward FDA approval.