Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Reproxalap QID · 1 trial · 1 indication
Change from baseline comparison of reproxalap to vehicle for subject-reported ocular dryness score VAS (0 = no discomfort - 100 = maximal discomfort), where a higher score means a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline calculated using baseline score, treatment arm, visit, and the interaction of treatment arm and visit as fixed effects.
Change from baseline comparison of reproxalap to vehicle for fluorescein staining of the nasal region (0 = none - 4 = severe), where a higher score means a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline calculated using baseline fluorescein nasal score, treatment arm, visit, and the interaction of treatment arm and visit as fixed effects.
| Arm | Type | Description |
|---|---|---|
| Reproxalap Ophthalmic Solution (0.25%) QID | EXPERIMENTAL | - |
| Vehicle Ophthalmic Solution QID | PLACEBO_COMPARATOR | - |
| Reproxalap Ophthalmic Solution (0.25%) QID to BID | EXPERIMENTAL | - |
| Vehicle Ophthalmic Solution QID to BID | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Reproxalap Ophthalmic Solution (0.25%) QID | DRUG | Reproxalap Ophthalmic Solution (0.25%) administered QID for twelve weeks |
| Vehicle Ophthalmic Solution QID | DRUG | Vehicle Ophthalmic Solution administered QID for twelve weeks |
| Reproxalap Ophthalmic Solution (0.25%) QID to BID | DRUG | Reproxalap Ophthalmic Solution (0.25%) administered QID for four weeks, followed by BID administration for eight weeks |
| Vehicle Ophthalmic Solution QID to BID | DRUG | Vehicle Ophthalmic Solution administered QID for four weeks, followed by BID administration for eight weeks |
Inclusion Criteria: * Be at least 18 years of age of either gender and any race; * Have a reported history of dry eye for at least 6 months prior to Visit 1; * Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1 Exclusion Criteria: * Have any clinicall...
Reproxalap QID is an investigational small molecule being developed for the treatment of Dry Eye. It is administered four times daily and is currently in Phase 3 clinical development. The drug is not yet approved and remains under investigation for this ophthalmic condition.
Reproxalap QID is a small molecule that targets reactive aldehyde species, which are elevated in dry eye disease. By binding to these aldehydes, the drug aims to reduce inflammation and oxidative stress associated with the condition. This mechanism is being evaluated in clinical trials.
Reproxalap QID is being developed by Aldeyra Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker ALDX. The company is focused on developing innovative therapies for inflammatory and metabolic diseases, with Reproxalap QID being one of its lead candidates for Dry Eye.
Reproxalap QID is in Phase 3 clinical development for Dry Eye. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 program includes a completed trial that evaluated the safety and efficacy of the drug in patients with Dry Eye.
Reproxalap QID was evaluated in the RENEW Trial (NCT03879863), a Phase 3, randomized, double-masked, vehicle-controlled study in 422 patients with Dry Eye. The trial was conducted in the United States and has been completed. The study assessed the safety and efficacy of the drug compared to placebo.
Reproxalap QID refers to a specific dosing regimen of Reproxalap, administered four times daily. The drug is being developed by Aldeyra Therapeutics for Dry Eye. The QID designation indicates the frequency of administration, while the underlying compound remains the same.