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Otx-Tki
Neovascular Age-Related Macular Degeneration (Namd)
Phase III
Recruiting
Study to Evaluate Long-Term Safety of Intravitreal OTX-TKI (Axitinib Implant) in Participants With Neovascular Age-Related Macular Degeneration Who Successfully Completed 2-Year OTX-TKI-2023-AMD-301 or OTX-TKI-2023-AMD-303 Study
Mar 31, 2026
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Aflibercept, Otx-Tki
Neovascular Age-Related Macular Degeneration
Phase III
Active Not Recruiting
Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration
Jul 03, 2024
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Aflibercept, Otx-Tki
Neovascular Age-Related Macular Degeneration
Phase III
Active Not Recruiting
Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Ocular Therapeutix) (Axitinib Implant) in Subjects With Neovascular Age-Related Macular Degeneration
Jan 12, 2024
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Otx-Ded, Controlled Insertion, Collagen Punctal Plug
Eye Diseases, Dry Eye Syndromes
Phase II
Completed
OTX-DED for the Short-term Treatment of the Symptoms of Dry Eye Disease (DED)
Mar 24, 2023
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Sham, Otx-Tki
Non-Proliferative Diabetic Retinopathy
Phase I
Active Not Recruiting
Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI in Subjects With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy
Jan 05, 2023
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Otx-Tic Low Dose Travoprost Intracameral Implant, Otx-Tic High Dose Travoprost Intracameral Implant, Durysta, Bimatoprost Intracameral Implant 10 Μg
Ocular Hypertension, Open Angle Glaucoma
Phase II
Completed
A Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant for Patients With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT)
Apr 12, 2022
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Otx-Tki/Sham, Aflibercept/Sham
Neovascular Age-Related Macular Degeneration
Phase I
Completed
Study Evaluating the Treatment of OTX-TKI for Subjects With Neovascular Age-related Macular Degeneration
Jul 02, 2021
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Dexamethasone Ophthalmic, Dilator
Healthy
Early Phase I
Terminated
A Human Factors Study to Evaluate a Novel Intracanalicular Insertion Device in Healthy Subjects
Jun 01, 2021
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Otx-Ded
Dry Eye
Phase II
Completed
To Assess the Efficacy and Safety of OTX-DED for the Short-term Treatment of Signs and Symptoms of Dry Eye Disease
Feb 04, 2021
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Dextenza Ophthalmic Insert, Prednisolone Acetate Ophthalmic Suspension Usp 1%
Cataract
Phase III
Completed
A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract
Aug 27, 2020
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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 Ocular Therapeutix (OCUL) have in its pipeline
OCUL is currently developing the following drugs: Otx-Tki, Aflibercept, Otx-Tki, Aflibercept, Otx-Tki. These drug candidates are in various stages of clinical development as the company works toward FDA approval.