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Label indication ALPHAGAN P (brimonidine tartrate ophthalmic solution) 0.1% or 0.15% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. ALPHAGAN P is an alpha adrenergic agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. ( 1 ) FDA label
Also known as Brimonidine Tartrate, OCU-310
Brimonidine · 2 trials · 1 indication
The SANDE questionnaire is a short Visual Analog Scale (VAS) assessment that quantifies both severity and frequency of current dry eye symptoms. The SANDE is comprised of two questions, and each question employs a 100-mm horizontal linear VAS. The measurement of symptom frequency ranges from "rarely" to "all of the time", and the symptom severity from "very mild" to "very severe". Data collected from the SANDE questionnaire was calculated by multiplying the frequency score by the severity score and obtaining the square root. The result is the Overall SANDE score which ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.
Conjunctival staining with Lissamine Green dye (1%; LG) staining in each eye was conducted using the slit lamp. A single drop of 1% Lissamine Green dye was applied to the inferior conjunctival fornix of both eyes. The conjunctivae was examined with the slit lamp at ×10 magnification, using a neutral-density filter. The conjunctiva was graded for each eye from 0 to 3 based on the density of punctate staining in the nasal-bulbar and temporal-bulbar zones. Total scores ranged from 0 (no staining) to 6 (most severe staining) with a lower score representing a more desirable outcome.
Participants assessed their tolerance to the administration of the study drug, utilizing a VAS. The VAS is a 100-mm horizontal line with verbal descriptors at either end. Participants placed a single slash mark across the horizontal line between the end labeled "completely intolerable" (0 mm) and "easily tolerable" (100mm).
| Arm | Type | Description |
|---|---|---|
| OCU-310 | EXPERIMENTAL | Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day for 4 weeks |
| Placebos | PLACEBO_COMPARATOR | Ophthalmic buffered saline Eye Drops given 2 times a day for 4 weeks |
| Study Drug Arm #1 | EXPERIMENTAL | Combination Therapy: brimonidine (0.2%) administered as eye drops, followed by corticosteroid eye drops, two times a day (BID) for 12 weeks |
| Study Drug Arm #2 | EXPERIMENTAL | Monotherapy: brimonidine (0.2%) administered as eye drops followed by placebo, two times a day (BID) for 12 weeks |
| Control Arm | PLACEBO_COMPARATOR | Placebo: sodium carboxymethylcellulose (0.25%) administered as eye drops followed by a second application, two time a day (BID) for 12 weeks |
| Name | Type | Description |
|---|---|---|
| Brimonidine Tartrate | DRUG | Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day for 4 weeks. |
| Placebos | DRUG | Ophthalmic buffered saline Eye Drops given 2 times a day for 4 weeks. |
| Brimonidine | DRUG | Two products delivered in sequence twice daily. |
| Brimonidine Mono Therapy | DRUG | Brimonidine given twice daily along with placebo drops |
| sodium carboxymethylcellulose | DRUG | Placebo given twice daily. |
| Corticosteroid Eye Drop | DRUG | Eye drop to be administered after Brimonidine in treatment arm 1 |
Inclusion Criteria: 1. Aged 18 years or older. 2. Sign and date informed consent form approved by the IRB 3. History of Dry Eye Disease for ≥6 months 4. Demonstrate the following 2 signs of DED in the same eye at Screening and Baseline (Day 1): 1. Conjunctival staining at ≥3 (out of a possible ...
Brimonidine is being developed as an eye drop treatment for dry eye disease. Ocugen, Inc. is studying a brimonidine tartrate nanoemulsion eye drop solution in adults with dry eye disease. The program has completed both a Phase 2 and a Phase 3 clinical trial in the United States.
Brimonidine targets the alpha-2 adrenergic receptors ADRA2A, ADRA2C, and ADRA2B, where it acts as an agonist. By binding and activating these receptors, brimonidine influences signaling pathways relevant to the ocular surface in dry eye disease. It is a small molecule administered as a topical eye drop.
Ocugen, Inc. (ticker OCGN) is developing brimonidine tartrate as a nanoemulsion eye drop solution for dry eye disease. The company has completed two clinical trials of the candidate, including a Phase 3 study and an earlier Phase 2 study, both conducted in the United States.
Brimonidine has completed a Phase 3 trial for dry eye disease, making it the most advanced stage reached in this program. It remains an investigational therapy and is not approved for dry eye disease. Both completed trials, a Phase 2 and a Phase 3, have finished enrollment and follow-up.
Two completed trials have studied brimonidine in dry eye disease. NCT03785340 was a Phase 3 study of brimonidine tartrate nanoemulsion eye drop solution with 252 participants. NCT03418727 was a Phase 2 dry eye disease study with 84 participants. Both were randomized, double-blind, placebo-controlled trials conducted in the United States.
Yes, brimonidine and brimonidine tartrate refer to the same active ingredient. Brimonidine tartrate is the salt form used in the eye drop formulation that Ocugen, Inc. is developing for dry eye disease. Searches for either name point to the same investigational dry eye program.