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Also known as R348 Ophthalmic Solution, 0.2%
R348, 0.2% · 3 trials · 2 indications
Change from baseline (Visit 1) of total CFS score at 12 weeks. Total CFS score range 0-20, where '0' represents no fluorescein staining of any region and '20' represents severe staining the entire cornea.
Change from baseline (Visit 3) of inferior region CFS score at 12 weeks. Inferior region CFS score range 0-4, where '0' represents no fluorescein staining and '4' represents severe staining on the cornea.
| Arm | Type | Description |
|---|---|---|
| R348 Ophthalmic Solution, 0.2% | ACTIVE_COMPARATOR | R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day |
| R348 Ophthalmic Solution, 0.5% | ACTIVE_COMPARATOR | R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day |
| Placebo | PLACEBO_COMPARATOR | Placebo Ophthalmic Solution 2 drops per eye twice a day |
| R348 Ophthalmic Solution, 1.0% | ACTIVE_COMPARATOR | R348 Ophthalmic Solution, 1.0%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day. |
| Name | Type | Description |
|---|---|---|
| R348 Ophthalmic Solution, 0.2% | DRUG | R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day |
| R348 Ophthalmic Solution, 0.5% | DRUG | R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day |
| Placebo Ophthalmic Solution | OTHER | Placebo Ophthalmic Solution 2 drops per eye twice a day |
| Placebo | DRUG | Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks. |
| R348 Ophthalmic Solution, 1.0% | DRUG | R348 Ophthalmic Solution, 1.0%, single and multiple ascending dose |
Inclusion Criteria: * Received an Allogeneic hematologic stem cell transplantation at least 3 months prior. * Subjects with post Allogeneic hematologic stem cell transplantation onset or worsening of dry eye symptoms for at least 1 month prior. * Use of over-the-counter and/or prescription eye drop...
R348, 0.2% is an investigational ophthalmic solution being studied for chronic graft-versus-host disease of the eye and keratoconjunctivitis sicca, also known as dry eye disease. Both are inflammatory conditions affecting the ocular surface. It is not approved for any indication and remains in clinical development.
R348, 0.2% is being developed by Rigel Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker RIGL. The company sponsored the Phase 1 and Phase 2 clinical trials of the ophthalmic solution in patients with ocular surface disease.
R348, 0.2% has completed Phase 2 clinical development. Two Phase 2 trials and one Phase 1 trial have been completed, and no trials are currently active. The program has not advanced to Phase 3, and the drug is not approved for any indication.
R348, 0.2% has been evaluated in three completed trials: NCT02040623, a Phase 2 study in chronic ocular graft-versus-host disease; NCT01900249, a Phase 2 study in keratoconjunctivitis sicca; and NCT01733992, a Phase 1 safety, tolerability, and pharmacokinetics study in dry eye disease.
Yes, R348, 0.2% and R348 Ophthalmic Solution, 0.2% refer to the same investigational product. The trial records also list it as R932348 ophthalmic solution. All of these names describe the same Rigel Pharmaceuticals eye drop formulation evaluated in the completed Phase 1 and Phase 2 studies.
The R348, 0.2% trials were randomized, double-blind, and placebo-controlled, enrolling a total of 240 participants across the completed studies. Participants were adults 18 years and older, and the trials were conducted in the United States. The studies enrolled patients with chronic ocular graft-versus-host disease and keratoconjunctivitis sicca.