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Oculis Holding (OCS)
NASDAQ:OCS
Vehicle, Dexamethasone Ophthalmic Suspension (Ocs-01)
Diabetic Macular Edema
Phase III
Active Not Recruiting
A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 2)
Dec 07, 2023
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Dexamethasone Ophthalmic Suspension, Vehicle Of Ocs-01
Cataract, Inflammation Eye, Pain, Postoperative
Phase III
Terminated
Study Evaluating the Efficacy and Safety of OCS-01 Eye Drops in Subjects Following Cataract Surgery
Nov 07, 2023
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Artificial Tears, Licaminlimab, Vehicle Of Ocs-02
Dry Eye Disease
Phase II
Completed
Safety and Efficacy of Licaminlimab Ophthalmic Solution for the Treatment of Dry Eye Disease
May 31, 2023
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Vehicle, Ocs-01
Inflammation Eye Pain, Postoperative Cataract
Phase III
Completed
A Phase 3 Study Evaluating the Efficacy and Safety of OCS-01 Eyedrops Compared to Vehicle for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Nov 24, 2021
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Vehicle, Dexamethasone Ophthalmic Suspension (Ocs-01)
Diabetic Macular Edema
Phase II/III
Active Not Recruiting
A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 1)
Sep 02, 2021
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Ocs-05 +Soc (Corticosteroid) Iv Administration
Optic Neuritis
Phase II
Completed
OCS-05 in Patients With Optic Neuritis
Feb 17, 2021
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Ocs-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% Mg/Ml
Pain, Postoperative, Inflammation Corneal
Phase II
Completed
OCS-01 in Treating Inflammation and Pain in Post-cataract Patients
Oct 16, 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 Oculis Holding (OCS) have in its pipeline
OCS is currently developing the following drugs: Vehicle, Dexamethasone Ophthalmic Suspension (Ocs-01), Dexamethasone Ophthalmic Suspension, Vehicle Of Ocs-01, Artificial Tears, Licaminlimab, Vehicle Of Ocs-02. These drug candidates are in various stages of clinical development as the company works toward FDA approval.