Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
lufepirsen high dose · 1 trial · 1 indication
The proportion of subjects achieving corneal re-epithelialization that is maintained for a minimum of 28 days, based on assessment of corneal fluorescein staining images of the PCED by a Central Reading Center (CRC).
| Arm | Type | Description |
|---|---|---|
| NEXAGON® (lufepirsen ophthalmic gel) High Dose Concentration | EXPERIMENTAL | Lufepirsen (High dose concentration) applied topically to the eye once a week for a minimum of 4 weeks to a maximum of 8 weeks. |
| NEXAGON Vehicle (ophthalmic gel) | PLACEBO_COMPARATOR | Vehicle applied topically to the eye once a week for a minimum of 4 weeks to a maximum of 8 weeks. |
| NEXAGON® (lufepirsen ophthalmic gel) Low Dose Concentration (EU sites only) | EXPERIMENTAL | Lufepirsen (Low dose concentration) applied topically to the eye once a week for a minimum of 4 weeks to a maximum of 8 weeks. (EU sites only). |
| Name | Type | Description |
|---|---|---|
| lufepirsen high dose | DRUG | Lufepirsen is an unmodified connexin43 antisense oligonucleotide. |
| Vehicle | DRUG | Matching vehicle without lufepirsen. |
| lufepirsen low dose | DRUG | Lufepirsen is an unmodified connexin43 antisense oligonucleotide. |
Inclusion Criteria: 1. Have a PCED that is at least 2 weeks in duration and refractory to one or more conventional non-surgical standard of care (SOC) treatments 2. Have no clinical evidence of improvement in the PCED within 2 weeks prior to randomization despite the use of non-surgical SOC treatme...
Lufepirsen high dose is an investigational ophthalmic gel being studied for the treatment of Persistent Corneal Epithelial Defect (PCED), a condition where the cornea's outer layer fails to heal. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Lufepirsen high dose is an antisense oligonucleotide (ASO), a class of small molecules that work by binding to specific RNA sequences to modulate gene expression. Its precise molecular target has not been disclosed in available information.
Lufepirsen high dose is being developed by Glaukos Corporation, a company traded on the New York Stock Exchange under the ticker symbol GKOS. The company is conducting clinical trials to evaluate the drug's safety and efficacy for Persistent Corneal Epithelial Defect.
Lufepirsen high dose is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by the FDA or other regulatory agencies. The ongoing trial is recruiting participants to assess its safety and efficacy.
Lufepirsen high dose is being evaluated in a Phase 2 clinical trial registered as NCT05966493. This randomized, double-blind, placebo-controlled study is assessing the safety and efficacy of NEXAGON (lufepirsen ophthalmic gel) in subjects with Persistent Corneal Epithelial Defect, with an enrollment target of 84 participants.
Yes, lufepirsen high dose is the same as NEXAGON, which is the brand name for lufepirsen ophthalmic gel. The clinical trial NCT05966493 uses the NEXAGON name to refer to the investigational drug being studied for Persistent Corneal Epithelial Defect.