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Also known as AGN-223575 ophthalmic solution
AGN-223575 · 1 trial · 1 indication
Nasal and temporal bulbar conjunctival hyperemia were graded separately in each eye by the investigator under slit-lamp magnification by assigning a score of 0 to 4 for each quadrant based on comparison to the Allergan Dry Eye Redness Scale with photographic reference where: 0=Normal, vessels of bulbar conjunctiva are easily observed; 1=Trace redness; 2=Mild redness; 3=Moderate redness; 4=Severe redness, and each score is associated with a reference photo. For each eye, the study quadrant was determined by the greater (more severe) of the baseline redness scores for nasal and temporal bulbar conjunctival hyperemia as assessed using the Allergan Dry Eye Redness Scale. If the temporal score was greater than the nasal score, then the temporal quadrant was the study quadrant for the eye and was used to assess primary efficacy; otherwise the nasal quadrant was the study quadrant. A negative change from baseline (less redness) indicates improvement.
| Arm | Type | Description |
|---|---|---|
| AGN-223575 Dose A | EXPERIMENTAL | 1 drop of AGN-223575 Dose A ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose A ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days. |
| AGN-223575 Dose B | EXPERIMENTAL | 1 drop of AGN-223575 Dose B ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose B ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days. |
| AGN-223575 Dose C | EXPERIMENTAL | 1 drop of AGN-223575 Dose C ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose C ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days. |
| AGN-223575 Vehicle | PLACEBO_COMPARATOR | 1 drop of Vehicle to AGN-223575 ophthalmic solution administered in each eye twice daily for 14 day followed by 1 drop of vehicle to AGN-223575 ophthalmic solution in each eye once daily for 7 days. |
| Name | Type | Description |
|---|---|---|
| AGN-223575 ophthalmic solution | DRUG | AGN-223575 ophthalmic solution once or twice daily |
| AGN-223575 vehicle ophthalmic solution | DRUG | Vehicle to AGN22375 ophthalmic solution once or twice daily. |
Inclusion Criteria: * Signs and symptoms of dry eye disease * Has used RESTASIS and/or artificial tears in both eyes twice a day for at least 60 days. Exclusion Criteria: * History of glaucoma, or ocular hypertension * Diagnosis of ocular infection * Use of contact lenses in the past 14 days or e...
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AGN-223575 is an investigational small molecule developed by AbbVie Inc. as an ophthalmic solution for dry eye syndromes. It has been studied in a Phase 2 clinical trial in adults with dry eye disease. It is not an approved therapy and remains in clinical development.
AGN-223575 is being developed for the treatment of dry eye syndromes, also known as dry eye disease. Its clinical testing has focused on adults 18 years and older with this condition. The drug is investigational and has not been approved for any use.
AGN-223575 is developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical program evaluating the ophthalmic solution in patients with dry eye disease.
AGN-223575 is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The drug is investigational and has not received FDA approval for dry eye syndromes or any other indication.
AGN-223575 has been evaluated in one completed Phase 2 trial, NCT02435914, titled a study of AGN-223575 ophthalmic suspension in patients with dry eye disease. The trial enrolled 236 participants in the United States, was randomized, double blind, and placebo controlled.
Yes. AGN-223575 ophthalmic solution is another name for AGN-223575, referring to the same investigational small molecule developed by AbbVie for dry eye syndromes. The ophthalmic solution formulation was the one studied in the completed Phase 2 trial.