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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 being developed for the treatment of dry eye syndromes. It is formulated as an ophthalmic suspension and is intended for use in patients with dry eye disease. The drug is currently in clinical development and has not been approved by regulatory authorities.
AGN-223575 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. AbbVie is conducting clinical trials to evaluate the safety and efficacy of this investigational ophthalmic treatment for dry eye disease.
AGN-223575 is in Phase 2 clinical development. A Phase 2 trial has been completed, evaluating the safety, efficacy, tolerability, and pharmacokinetics of the drug in patients with dry eye disease. The drug remains investigational and is not yet approved for commercial use.
AGN-223575 has one completed clinical trial, identified as NCT02435914. This Phase 2 study, titled 'Safety, Efficacy, Tolerability and Pharmacokinetics of AGN-223575 Ophthalmic Suspension in Patients With Dry Eye Disease,' enrolled 236 participants in the United States. The trial was randomized, double-blind, and placebo-controlled.
AGN-223575 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for dry eye syndromes. A Phase 2 trial has been completed, but the drug has not yet received regulatory approval for marketing or use in patients.