Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AL-53817, 0.1% · 1 trial · 1 indication
Ocular redness ratings were collected for nasal and temporal areas of each eye and assessed by investigational center staff using a visual scale (ie, scored by comparing the subject's eye with a series of photographs) and graded on a scale from 0 (none) to 4 (extremely severe), 0.5 unit steps permitted. AUC was calculated using the trapezoidal rule with unequal intervals as determined by the assessment time points. Change was calculated as AUC(0-10)\[Day 7\] - AUC(0-10) \[Baseline\]. Both eyes contributed to the analysis.
| Arm | Type | Description |
|---|---|---|
| AL-53817 | EXPERIMENTAL | AL-53817 Ophthalmic Solution, 0.1%, 1 drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9) |
| AL-78843 | EXPERIMENTAL | AL-78843 Ophthalmic Solution, 0.03%, 1 drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9) |
| Maxidex | ACTIVE_COMPARATOR | Dexamethasone Ophthalmic Suspension, 0.1%, 1 drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9) |
| Vehicle | PLACEBO_COMPARATOR | AL-53817 Vehicle, 1 drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9) |
| Name | Type | Description |
|---|---|---|
| AL-53817 Ophthalmic Solution, 0.1% | DRUG | - |
| AL-78843 Ophthalmic Solution, 0.03% | DRUG | - |
| Dexamethasone Ophthalmic Suspension, 0.1% | DRUG | - |
| AL-53817 Vehicle | DRUG | Inactive ingredients used for masking purposes |
Inclusion Criteria: * Sign Informed Consent * Use of condom by sexually active males for the entire duration of the study. * Best corrected visual acuity of 55 or greater in each eye as measured by ETDRS (letters read method). * Able and willing to comply with study protocol and follow protocol ins...
AL-53817 is an investigational small molecule being developed by Alcon Inc. for the treatment of allergic conjunctivitis and nasal allergies. It has been studied as a nasal spray solution for nasal allergies and as an ophthalmic solution for allergic conjunctivitis. The drug is still in clinical development and is not approved.
AL-53817 is being developed by Alcon Inc., a company traded on the New York Stock Exchange under the ticker ALC. Alcon has conducted clinical trials of AL-53817 for allergic conjunctivitis and nasal allergies.
AL-53817 has completed Phase 1 and Phase 2 clinical trials. A Phase 1 trial of the nasal spray solution for nasal allergies was completed, and a Phase 2 trial of the ophthalmic solution for allergic conjunctivitis was also completed. The drug remains investigational.
AL-53817 has been studied in two completed trials. NCT01454505 was a Phase 1 safety and efficacy study of AL-53817 nasal spray solution for nasal allergies with 110 participants. NCT02079649 was a Phase 2 study of AL-53817 and AL-78843 ophthalmic solutions for allergic conjunctivitis with 224 participants.
No, AL-53817 and AL-78843 are different investigational drugs. They were studied together in a Phase 2 clinical trial (NCT02079649) that evaluated both ophthalmic solutions for the treatment of allergic conjunctivitis, but they are separate compounds.