Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GLK-321 low dose BID, GLK-321 low dose, GLK-321 mid dose BID, GLK-321 mid dose
GLK-321 · 1 trial · 1 indication
Percentage of study eyes that had eyelash collarettes due to Demodex blepharitis at the onset of treatment who demonstrate absence of collarettes after 6 weeks of treatment
| Arm | Type | Description |
|---|---|---|
| GLK-321 low dose BID | EXPERIMENTAL | Low dose of GLK-321 administered twice daily (BID) to both eyes |
| GLK-321 mid dose BID | EXPERIMENTAL | Mid dose of GLK-321 administered twice daily (BID) to both eyes |
| GLK-321 high dose BID | EXPERIMENTAL | High dose of GLK-321 administered twice daily (BID) to both eyes |
| GLK-321 high dose QD | EXPERIMENTAL | High dose of GLK-321 administered once daily (QD) to both eyes |
| Placebo BID | PLACEBO_COMPARATOR | Placebo administered twice daily (BID) to both eyes |
| Name | Type | Description |
|---|---|---|
| GLK-321 low dose BID | DRUG | Twice daily administration of low dose GLK-321 to both eyes |
| GLK-321 mid dose BID | DRUG | Twice daily administration of mid dose GLK-321 to both eyes |
| GLK-321 high dose BID | DRUG | Twice daily administration of high dose GLK-321 to both eyes |
| GLK-321 high dose QD | DRUG | Once daily administration of high dose GLK-321 to both eyes |
| Placebo BID | DRUG | Twice daily administration of placebo to both eyes |
Inclusion Criteria: * Signs of Demodex blepharitis in at least one eye * Best Spectacle Corrected Visual Acuity (BSCVA) of 20/80 Snellen or better in each eye Exclusion Criteria: * Presence of eczema or dermatitis in the ocular region of either eye * Use of lid hygiene products within 14 days of ...
GLK-321 is being developed for the treatment of Demodex blepharitis, an eyelid condition associated with Demodex mites. It is an investigational small molecule eye care candidate from Glaukos Corporation and has not been approved for commercial use. Clinical evaluation is currently limited to patients with this condition.
GLK-321 is being developed by Glaukos Corporation, which trades on the New York Stock Exchange under the ticker GKOS. The company is running the clinical program for the asset in Demodex blepharitis, with the work conducted in the United States.
GLK-321 is in Phase 2 clinical development. The program consists of one recruiting Phase 2 trial in Demodex blepharitis, and no Phase 3 or later-stage studies have been recorded. The drug remains investigational and is not approved for any indication.
GLK-321 is being studied in the Phase 2 trial NCT07400965, titled Evaluation of the Safety and Efficacy of GLK-321 in Subjects With Demodex Blepharitis. The trial is recruiting in the United States, is randomized, double blind, and placebo controlled, and plans to enroll 250 participants aged 18 years and older.
Yes. GLK-321 low dose BID, GLK-321 low dose, GLK-321 mid dose BID, and GLK-321 mid dose are alternative names used for the same investigational asset, GLK-321. These labels refer to different dose levels and dosing schedules evaluated within the same clinical program in Demodex blepharitis.