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Ocular Therapeutix (OCUL) Drug Pipeline
| Drug Name | Condition | Stage | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| 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 | ― |
| 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 | ― |
| 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 | ― |
| 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 | ― |
| 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 | ― |
| 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 | ― |
| 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 | ― |
| Dexamethasone Ophthalmic, Dilator | Healthy | earlyPhase1 | Terminated | A Human Factors Study to Evaluate a Novel Intracanalicular Insertion Device in Healthy Subjects | Jun 01, 2021 | ― |
| 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 | ― |
| 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 | ― |
| Drug Name | Stage | Condition | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Otx-Tki | Phase III | Neovascular Age-Related Macular Degeneration (Namd) | 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 | ― |
| Aflibercept, Otx-Tki | Phase III | Neovascular Age-Related Macular Degeneration | 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 | ― |
| Aflibercept, Otx-Tki | Phase III | Neovascular Age-Related Macular Degeneration | 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 | ― |
| Otx-Ded, Controlled Insertion, Collagen Punctal Plug | Phase II | Eye Diseases, Dry Eye Syndromes | Completed | OTX-DED for the Short-term Treatment of the Symptoms of Dry Eye Disease (DED) | Mar 24, 2023 | ― |
| Sham, Otx-Tki | Phase I | Non-Proliferative Diabetic Retinopathy | 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 | ― |
| Otx-Tic Low Dose Travoprost Intracameral Implant, Otx-Tic High Dose Travoprost Intracameral Implant, Durysta, Bimatoprost Intracameral Implant 10 Μg | Phase II | Ocular Hypertension, Open Angle Glaucoma | 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 | ― |
| Otx-Tki/Sham, Aflibercept/Sham | Phase I | Neovascular Age-Related Macular Degeneration | Completed | Study Evaluating the Treatment of OTX-TKI for Subjects With Neovascular Age-related Macular Degeneration | Jul 02, 2021 | ― |
| Dexamethasone Ophthalmic, Dilator | earlyPhase1 | Healthy | Terminated | A Human Factors Study to Evaluate a Novel Intracanalicular Insertion Device in Healthy Subjects | Jun 01, 2021 | ― |
| Otx-Ded | Phase II | Dry Eye | 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 | ― |
| Dextenza Ophthalmic Insert, Prednisolone Acetate Ophthalmic Suspension Usp 1% | Phase III | Cataract | 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 | ― |
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
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 Inc (OCUL) have in its pipeline
Ocular Therapeutix OCUL is currently developing the following drugs: Otx-Tki, Aflibercept, Otx-Tki, Otx-Ded, Controlled Insertion, Collagen Punctal Plug, Sham, Otx-Tki, Otx-Tic Low Dose Travoprost Intracameral Implant, Otx-Tic High Dose Travoprost Intracameral Implant, Durysta, Bimatoprost Intracameral Implant 10 Μg, Otx-Tki/Sham, Aflibercept/Sham, Dexamethasone Ophthalmic, Dilator, Otx-Ded, Dextenza Ophthalmic Insert, Prednisolone Acetate Ophthalmic Suspension Usp 1%, Otx-Csi, Otx-Tic, Ophthalmic Insert, Dexamethasone, 0.4Mg, Anti-Vegf, Otx-Tki, Dexamethasone, Travoprost, Otx-Tp, Timolol, Dexamethasone, Punctum Plug, Otx-Tpa ~4Μg/Day Over 2 Mos. With Natural Tears Drops, Otx-Tpb ~3Μg/Day Over 3 Months With Natural Tears Drops, Timolol Maleate Dosed Twice Daily With Punctum Plug Without Drug, Punctum Plug, Otx-Dp, Resure Sealant, Sutures. These drug candidates are in various stages of clinical development as the company works toward FDA approval.