Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AGN-199201 ophthalmic solution, Oxymetazoline HCL Cream 1.0%
AGN-199201 · 5 trials · 3 indications
The investigator assessed the patient's overall severity of erythema in the treatment area on the 5 point CEA scale (ranging from 0=clear skin with no signs of erythema to 4=severe erythema/fiery redness). The patient assessed the overall severity of rosacea facial redness in the treatment area on the 5 point SSA scale (ranging from 0=no signs of unwanted redness to 4=severe redness). The percentage of patients with at least a 2 grade decrease (improvement) on both CEA and SSA from baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on day 29. Baseline was defined as the measurement at predose on Day 1.
UNVA is assessed without corrective lenses in the non-dominant eye. UNVA is measured using an eye chart and is reported as the number of lines read correctly. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of lines read correctly means that vision has improved.
UNVA is assessed without corrective lenses in the non-dominant eye. UNVA is measured using an eye chart and is reported as the number of lines read correctly. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of lines read correctly means that vision has improved.
UNVA is assessed without corrective lenses in the non-dominant eye. UNVA is measured using an eye chart and is reported as the number of lines read correctly. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of lines read correctly means that vision has improved. The percentages of patients with at least a 2 or more line improvement in UNVA in the non-dominant eye are presented.
Percentage of participants with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score were assessed on Day 28 hours 2 to 12. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.
| Arm | Type | Description |
|---|---|---|
| AGN-199201 | EXPERIMENTAL | AGN-199201 applied to the face once daily for 29 days. |
| Vehicle | PLACEBO_COMPARATOR | Vehicle to AGN-199201 applied to the face once daily for 29 days. |
| Cohort 1: Vehicle Control | EXPERIMENTAL | Vehicle dosed in both eyes administered once daily during office visits 1 through 5. |
| Cohort 2: AGN-199201 Dose A and AGN-190584 Dose A | EXPERIMENTAL | Fixed combinations of AGN-199201 Dose A and AGN-190584 Dose A dosed in both eyes administered once daily during office visits 1 through 5. |
| Cohort 3: AGN-199201 Dose B and AGN-190584 Dose B | EXPERIMENTAL | Fixed combinations of AGN-199201 Dose B and AGN-190584 Dose B dosed in both eyes administered once daily during office visits 1 through 5. |
| Cohort 4: AGN-199201 Dose C and AGN-190584 Dose C | EXPERIMENTAL | Fixed combinations of AGN-199201 Dose C and AGN-190584 Dose C dosed in both eyes administered once daily during office visits 1 through 5. |
| Cohort 5: Vehicle, AGN-199201 Dose C and AGN-190584 Dose C | EXPERIMENTAL | Dominant eye dosed with Vehicle. Fixed combinations of AGN-199201 Dose C and AGN-190584 Dose C dosed in nondominant eye. Treatment administered once daily during office visits 1 through 5. |
| AGN-199201 and AGN-190584 Vehicle | EXPERIMENTAL | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. |
| AGN-199201 and AGN-190584 Dose A | EXPERIMENTAL | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. |
| AGN-199201 and AGN-190584 Dose B | EXPERIMENTAL | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. |
| AGN-199201 and AGN-190584 Dose C | EXPERIMENTAL | Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. |
| AGN-190584 | EXPERIMENTAL | 1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each. |
| AGN-199201 + AGN-190584 in One Eye | EXPERIMENTAL | 1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each. |
| AGN-199201 + AGN-190584 in Both Eyes | EXPERIMENTAL | 1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each. |
| AGN-199201 Dose A Once Daily | EXPERIMENTAL | AGN-199201 Dose A applied once daily to the face for 28 days. |
| AGN-199201 Dose B Once Daily | EXPERIMENTAL | AGN-199201 Dose B applied once daily to the face for 28 days. |
| AGN-199201 Dose C Once Daily | EXPERIMENTAL | AGN-199201 Dose C applied once daily to the face for 28 days. |
| AGN-199201 Vehicle Once Daily | PLACEBO_COMPARATOR | AGN-199201 Vehicle applied once daily to the face for 28 days. |
| AGN-199201 Dose A Twice Daily | EXPERIMENTAL | AGN-199201 Dose A applied twice daily to the face for 28 days. |
| AGN-199201 Dose B Twice Daily | EXPERIMENTAL | AGN-199201 Dose B applied twice daily to the face for 28 days. |
| AGN-199201 Dose C Twice Daily | EXPERIMENTAL | AGN-199201 Dose C applied twice daily to the face for 28 days. |
| AGN-199201 Vehicle Twice Daily | PLACEBO_COMPARATOR | AGN-199201 Vehicle applied twice daily to the face for 28 days. |
| Name | Type | Description |
|---|---|---|
| AGN-199201 | DRUG | AGN-199201 applied to the face once daily for 29 days. |
| Vehicle to AGN-199201 | DRUG | Vehicle to AGN-199201 applied to the face once daily for 29 days. |
| AGN-199201 ophthalmic solution | DRUG | 1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye. |
| AGN-190584 ophthalmic solution | DRUG | 1 drop of AGN-190584 ophthalmic solution Doses A, B, C in the eye. |
| AGN-199201 Vehicle | DRUG | Vehicle to AGN-199201 |
| AGN-190584 Vehicle | DRUG | Vehicle to AGN-190584 |
| AGN-199201 + AGN-190584 Combination | DRUG | 1 drop AGN-199201 and AGN-190584 fixed combination ophthalmic solution in the eye. |
| AGN-190584 | DRUG | 1 to 2 drops of AGN-190584 ophthalmic solution in the eye(s) as per protocol. |
| AGN-199201 Dose A | DRUG | AGN-199201 Dose A applied once or twice daily to the face for 28 days. |
| AGN-199201 Dose B | DRUG | AGN-199201 Dose B applied once or twice daily to the face for 28 days. |
| AGN-199201 Dose C | DRUG | AGN-199201 Dose C applied once or twice daily to the face for 28 days. |
Inclusion Criteria: -Moderate to severe persistent facial erythema associated with rosacea. Exclusion Criteria: * Greater than 3 inflammatory lesions on the face * Current treatment with monoamine oxidase (MAO) inhibitors * Raynaud's syndrome, narrow angle glaucoma, orthostatic hypotension, scler...
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AGN-199201 is an investigational small molecule developed by AbbVie Inc. (ticker ABBV) as an ophthalmic solution. It has been studied in presbyopia, persistent erythema associated with rosacea, and rosacea. The program has reached Phase 3, and the clinical trials conducted to date have been completed.
AGN-199201 has been studied for presbyopia and for persistent erythema associated with rosacea. Its clinical program covers both dermatology and eye-related indications, with the Phase 3 trial enrolling patients with erythema and rosacea and the Phase 2 trials enrolling patients with presbyopia.
AGN-199201 is developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie is the sponsor of the clinical program for the ophthalmic solution across the presbyopia and rosacea-related studies.
AGN-199201 has reached Phase 3. The Phase 3 study was a placebo-controlled trial in patients with persistent erythema associated with rosacea. The remaining studies of AGN-199201 were Phase 2 trials in presbyopia, and all trials of the drug have been completed.
AGN-199201 has been evaluated in completed trials including NCT02131636, a Phase 3 study in erythema and rosacea, and the Phase 2 presbyopia trials NCT02780115, NCT02595528, and NCT02197806. These randomized, double-blind, placebo-controlled studies enrolled a total of 440 participants.
Yes. AGN-199201 ophthalmic solution and AGN-199201 Dose A are alternative names for AGN-199201, the investigational small molecule from AbbVie. Searches using those names refer to the same development program in presbyopia and rosacea-related erythema.