Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AL-53817 nasal spray solution
AL-53817 · 2 trials · 3 indications
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.
Adverse events, including serious adverse events and deaths, were reported regardless of test article relationship.
Stage B: Nasal congestion was assessed by the subject before entering the EEC and at 14 timepoints over a 6-hour period after entering the EEC. Nasal congestion was scored on a scale from 0-3, where 0=none and 3=severe. Baseline EEC was conducted up to 21 days prior to the 5-day treatment period.
| 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) |
| Stage B/AL-53817 | EXPERIMENTAL | Stage B: AL-53817 nasal spray solution, 1 spray to each nostril twice a day for 4 days. On Day 5, 1 spray to each nostril 60 minutes before entering the EEC. |
| Stage B/Vehicle | PLACEBO_COMPARATOR | Stage B: Vehicle nasal spray, 1 spray to each nostril twice a day for 4 days. On Day 5, 1 spray to each nostril 60 minutes before entering the EEC. |
| 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 |
| AL-53817 nasal spray solution | DRUG | Active ingredients administered in 1 of 3 concentrations during Stage A to determine maximum tolerated dose (MTD), and administered at maximum tolerated dose during Stage B. |
| Vehicle nasal spray | OTHER | Inactive ingredients used as placebo comparator during Stage A and Stage B. |
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 for allergic conjunctivitis and nasal allergies. It is being studied in both ophthalmic solution and nasal spray formulations. Alcon Inc. is developing the drug, which has completed Phase 2 testing in allergic conjunctivitis and Phase 1 testing in nasal allergies.
AL-53817 is being developed by Alcon Inc., which trades under the ticker ALC. Alcon is an eye care company, and AL-53817 is part of its ophthalmology pipeline. The drug is an investigational small molecule with both ophthalmic and nasal spray formulations under study.
AL-53817 has completed a Phase 2 trial in allergic conjunctivitis and a Phase 1 trial in nasal allergies. No active trials are currently listed. The drug remains investigational and has not been approved by the FDA for any indication.
AL-53817 has been studied in two completed trials. NCT02079649 was a Phase 2 randomized, double-blind, placebo-controlled study of AL-53817 and AL-78843 ophthalmic solutions for allergic conjunctivitis, enrolling 224 adults. NCT01454505 was a Phase 1 study of AL-53817 nasal spray solution in 110 healthy volunteers in the United States.
Yes, AL-53817 nasal spray solution and AL-53817 Ophthalmic Solution, 0.1% are alternative names for the same investigational drug, AL-53817. The nasal spray formulation was studied in a Phase 1 trial for nasal allergies, while the ophthalmic solution was studied in a Phase 2 trial for allergic conjunctivitis.