Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
0.003% AR-15512 · 3 trials · 1 indication
Treatment-emergent adverse events (TEAEs) were defined as any event that occurred or worsened on or after the day that study intervention was initiated. No hypothesis testing was prespecified for this endpoint.
TMH (the distance between the line of reflection along the top of the tear prism to the edge of the central lower eyelid) was measured pre-instillation and post-instillation in micrometers using optical coherence tomography (OCT), a non-invasive imaging test that uses light waves to take cross-section pictures of the eye. A normal TMH range falls between 200 and 400 micrometers. Measurements below this range may indicate dry eye disease. A positive change value indicates an improvement. One eye (study eye, defined as the left eye) contributed data to the analysis.
TMH (the distance between the line of reflection along the top of the tear prism to the edge of the central lower eyelid) was measured pre-instillation and post-instillation in micrometers using optical coherence tomography (OCT), a non-invasive imaging test that uses light waves to take cross-section pictures of the eye. A normal TMH range falls between 200 and 400 micrometers. Measurements below this range may indicate dry eye disease. A positive change value indicates an improvement. One eye (study eye, defined as the left eye) contributed data to the analysis.
Goblet cells are specialized epithelial cells that secrete mucins onto the ocular surface to help hydrate and lubricate the eye surface. Samples of conjunctiva were collected on filter papers based on a technique called impression cytology. The filter papers were then processed in a lab to measure the number of goblet cells (cells/mm2). The percent change in goblet cell density at Day 90 compared to Day 1 (Baseline) was calculated. A positive change value indicates an improvement. Only one eye (study eye) contributed data to the analysis. This outcome measure was pre-specified for 0.003% AR-15512 arm only.
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | OTHER | One drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-RT, then 512-COLD, followed by 512-RT-EC, and finally 512-COLD-EC. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation. |
| Sequence 2 | OTHER | One drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-RT-EC, then 512-RT, followed by 512-COLD-EC, and finally 512-COLD. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation. |
| Sequence 3 | OTHER | One drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-COLD, then 512-COLD-EC, followed by 512-RT, and finally 512-RT-EC. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation. |
| Sequence 4 | OTHER | One drop of artificial tears in the right eye, followed by 0.003% AR-15512 ophthalmic solution in four different instillation variations: 512-COLD-EC, then 512-RT-EC, followed by 512-COLD, and finally 512-RT. Each instillation consisted of 1 drop in 1 eye only starting with the left eye and alternating the eyes thereafter. Protocol-specified wait periods separated each instillation. |
| 0.003% AR-15512 | EXPERIMENTAL | One drop of 0.003% AR-15512 ophthalmic solution in each eye in a staggered cadence (left eye followed by dosing of the right eye, separated by approximately 2-4 hours) |
| Artificial Tears | ACTIVE_COMPARATOR | One drop of artificial tears in each eye twice daily for 90 days (treatment period) |
| Name | Type | Description |
|---|---|---|
| 0.003% AR-15512 ophthalmic solution | DRUG | Investigational ophthalmic solution administered topically in 4 different instillation variations: 512-RT (0.003% AR-15512 instilled at room temperature, eyes to remain open post-drop instillation); 512-COLD (0.003% AR-15512 stored in refrigerator and instilled immediately after removal from refrigerator, eyes to remain open post-drop instillation); 512-RT-EC (0.003% AR-15512 instilled at room temperature followed by subjects immediately closing their eyes); and 512-COLD-EC (0.003% AR-15512 stored in refrigerator and instilled immediately after removal from refrigerator followed by subjects immediately closing their eyes). |
| Artificial tears | DRUG | Commercially available, preservative-free lubricant eye drops administered topically |
Key Inclusion Criteria: * Corrected Visual Acuity (Snellen) 20/200 or better in both eyes; * Good general and ocular health, as determined by the Investigator using medical history, ophthalmic examination and history; * Capable of giving signed informed consent. * Other protocol-defined inclusion c...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 2 | PHASE3 | ABBV-444, REFRESH OPTIVE UD |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE2 | VSJ-110 |
| Oculis Holding AG | OCS | 1 | PHASE2 | licaminlimab |
| Alcon AG | ALC | 1 | N/A | Undisclosed |
| Harrow, Inc. | HROW | 1 | - | Undisclosed |
0.003% AR-15512 is an investigational small molecule being developed for the treatment of Dry Eye Disease. It is administered as an ophthalmic solution and is currently in Phase 3 clinical development. The drug is being studied to evaluate its effect on tear production and overall safety in patients with dry eye.
0.003% AR-15512 is being developed by Alcon Inc., a company traded on the New York Stock Exchange under the ticker symbol ALC. Alcon is a global medical device and pharmaceutical company focused on eye care, and it is advancing this drug candidate through Phase 3 clinical trials for Dry Eye Disease.
0.003% AR-15512 is in Phase 3 clinical development for Dry Eye Disease. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. Three Phase 3 trials have been completed, all of which were randomized, double-blind, and controlled studies conducted in the United States.
0.003% AR-15512 has completed three Phase 3 clinical trials in the United States: NCT06544694, which investigated its effect on Dry Eye Disease with 80 participants; NCT06544707, which evaluated tear production with 81 participants; and NCT06660290, which assessed safety and drop attributes with 55 participants. All trials enrolled adults aged 18 and older.
0.003% AR-15512 is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for Dry Eye Disease. While three Phase 3 trials have been completed, the drug has not yet received regulatory approval and remains under investigation for safety and efficacy.