Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PL9643 · 1 trial · 1 indication
An assessment of corneal fluorescein staining using the 0 \[none\] to 4 \[worst\] Ora Calibra Scale prior to and following exposure to a challenge in a controlled adverse environment (CAE)
A patient-reported subjective assessment of ocular discomfort using the 0 \[none\] to 4 \[worst\] Ora Calibra Scale recorded at each study visit throughout the treatment period
| Arm | Type | Description |
|---|---|---|
| Placebo Ophthalmic Solution (vehicle) | PLACEBO_COMPARATOR | vehicle |
| PL9643 Ophthalmic Solution | ACTIVE_COMPARATOR | PL9643 Ophthalmic Solution |
| Name | Type | Description |
|---|---|---|
| PL9643 Ophthalmic Solution | DRUG | PL9643 Ophthalmic Solution as topical ophthalmic drops administered bilaterally for 12 weeks. |
| Placebo Ophthalmic Solution | DRUG | Placebo solution as topical ophthalmic drops administered bilaterally for 12 weeks. |
Inclusion Criteria: * Be at least 18 years of age. * Provided written informed consent. * Have a reported history of dry eye * Have a history of use or desire to use eye drops for dry eye symptoms * Have corrected visual acuity greater than or equal to +0.7 in both eyes Exclusion Criteria: * Be d...
| 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 |
PL9643 is an investigational small molecule being developed for the treatment of Dry Eye Disease. It is formulated as an ophthalmic solution and is currently in clinical development, having completed a Phase 2 trial. PL9643 is not yet approved by the FDA and remains under investigation for this condition.
PL9643 is being developed by Palatin Technologies, Inc., a biopharmaceutical company traded on the NYSE American under the ticker symbol PTN. The company is conducting clinical research on this ophthalmic solution for Dry Eye Disease.
PL9643 is in Phase 2 clinical development. A Phase 2 trial has been completed, and the drug remains investigational. It has not received FDA approval and is still being studied for safety and efficacy in patients with Dry Eye Disease.
PL9643 has one completed clinical trial, NCT04268069, titled 'Efficacy and Safety of PL9643 Ophthalmic Solution in Subjects With Dry Eye.' This Phase 2, randomized, double-blind, placebo-controlled study enrolled 160 participants in the United States and evaluated the treatment for Dry Eye Disease.
PL9643 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Dry Eye Disease. A Phase 2 trial has been completed, but the drug has not yet received regulatory approval and continues to be evaluated in clinical studies.