Approval Probability
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Also known as PL9643 Ophthalmic Solution
PL9643 · 2 trials · 3 indications
Measured by the Ora Calibra® Scale. Change from Baseline to week 12.
As Measured by Visual Analog Scale (VAS). PL9643 versus Vehicle, in hyper-responder sub-population. Hyper-responder sub-population is defined as those patients achieving a VAS score of 4 or greater within the first 30 minutes of being challenged in the CAE® (clinical symptom) at Visit 2.
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 |
|---|---|---|
| PL9643 Ophthalmic Solution | EXPERIMENTAL | PL9643 ophthalmic solution bilaterally three times a day. |
| Vehicle Ophthalmic Solution | ACTIVE_COMPARATOR | Vehicle ophthalmic solution bilaterally three times a day. |
| Placebo Ophthalmic Solution (vehicle) | PLACEBO_COMPARATOR | vehicle |
| Name | Type | Description |
|---|---|---|
| Vehicle Ophthalmic Solution | DRUG | Ophthalmic Solution |
| PL9643 Ophthalmic Solution | DRUG | Ophthalmic Solution |
| Placebo Ophthalmic Solution | DRUG | Placebo solution as topical ophthalmic drops administered bilaterally for 12 weeks. |
Inclusion Criteria: 1. Be at least 18 years of age; 2. Provide written informed consent; 3. Be willing and able to comply with all study procedures; 4. Have a patient-reported history of dry eye for at least 5 years prior to Visit 1; 5. Have a history of use or desire to use eye drops for dry eye s...
PL9643 is an investigational ophthalmic solution being developed for the treatment of dry eye disease. It is a small molecule formulated as an eye drop and is currently in Phase 3 clinical development. The program is led by Palatin Technologies, Inc. under the ticker PTN.
PL9643 targets the melanocortin 1 receptor, or MC1R, a receptor involved in regulating inflammation and immune responses. By activating MC1R, the drug is designed to address the inflammatory component of dry eye disease. This mechanism distinguishes it from conventional lubricating or anti-inflammatory eye drops.
PL9643 is being developed by Palatin Technologies, Inc., a biopharmaceutical company that trades under the ticker symbol PTN. Palatin is responsible for the clinical development program of PL9643, including the Phase 2 and Phase 3 trials conducted in the United States.
PL9643 is in Phase 3 clinical development for dry eye disease. A Phase 3 trial has been completed, and the drug remains investigational, meaning it has not been approved by the FDA for any indication. Further regulatory steps would be required before any potential approval.
PL9643 has been studied in two completed trials: a Phase 3 trial, NCT05201170, which enrolled 575 patients with dry eye, and a Phase 2 trial, NCT04268069, which enrolled 160 patients with dry eye disease. Both were conducted in the United States.
Yes, PL9643 Ophthalmic Solution is another name for PL9643. The term refers to the same investigational small molecule formulated as an eye drop for the treatment of dry eye disease. Both names are used interchangeably in reference to the Palatin Technologies development program.