Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BTOS-HA · 1 trial · 1 indication
Ocular redness score (0-4 unit scale, allowing half-unit increments) evaluated by the investigator at Visit 2 (Day 1) prior to investigational drug instillation and after investigational drug instillation at 5(+1) minutes, 15(+1) minutes, 30(+1) minutes, 60(+10) minutes, 90(+10) minutes, 120(+15) minutes, 180(+15) minutes, 240(+15) minutes
| Arm | Type | Description |
|---|---|---|
| Brimonidine tartrate ophthalmic solution 0.025% with sodium hyaluronate (BTOS-HA) | EXPERIMENTAL | - |
| Brimonidine tartrate ophthalmic solution 0.025% | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| BTOS-HA | DRUG | Brimonidine tartrate ophthalmic solution 0.025% with sodium hyaluronate (BTOS-HA) administered as 1 topical ocular drop instilled into each eye (OU), 4 times daily (QID), approximately 4 hours apart |
| Lumify® | DRUG | Brimonidine tartrate ophthalmic solution 0.025%, administered as 1 topical ocular drop instilled into each eye (OU), 4 times daily (QID), approximately 4 hours apart |
Inclusion Criteria: 1. Voluntarily provide written informed consent 2. ≥18 years of age 3. Able and willing to follow instructions, including participation in all trial assessments and visits 4. History of vasoconstrictor (redness relief drops) use within the last 6 months, or a desire to use over ...
BTOS-HA is an investigational small molecule being developed for ocular redness. It is a brimonidine tartrate ophthalmic solution 0.025% combined with sodium hyaluronate, intended to reduce eye redness in adult patients. The drug is currently in Phase 3 clinical development and has not yet been approved by regulatory authorities.
BTOS-HA is being developed by Bausch + Lomb Corporation, a company publicly traded under the ticker symbol BLCO. The company is conducting clinical trials to evaluate the efficacy and safety of this ophthalmic solution for the treatment of ocular redness in adult subjects.
BTOS-HA is in Phase 3 clinical development. A Phase 3 trial has been completed, comparing the drug to an active control in adult subjects with ocular redness. The drug remains investigational and is not yet approved for commercial use.
BTOS-HA has one completed Phase 3 clinical trial, registered under NCT06803654. The study compared brimonidine tartrate ophthalmic solution 0.025% with sodium hyaluronate to Lumify in 578 adult subjects with ocular redness. The trial was conducted in the United States and was active-controlled.
BTOS-HA contains brimonidine tartrate, an alpha-adrenergic receptor agonist, combined with sodium hyaluronate. Brimonidine tartrate works by constricting blood vessels in the eye, which reduces redness. The sodium hyaluronate component provides lubrication and may enhance comfort during application.