Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Reproxalap · 15 trials · 6 indications
Measured using a 0 - 100 visual analog scale (VAS) where 0 is "no discomfort" and 100 is "maximal discomfort"
Measured using a 0 - 100 visual analog scale where 0 is "no discomfort" and 100 is "maximal discomfort"
Measured using a 0 - 100 visual analog scale (VAS) where 0 is "no discomfort" and 100 is "maximal discomfort"
The method of assessment was a 9-point ocular itch scale measured in half-unit increments (0 none - 4 severe) with a higher score representing worse symptomology. Subjects were dosed once just prior to allergen chamber entry and again halfway through the chamber. The allergen chamber was 210 ten minutes in duration with the itching assessment being collected every 10 minutes from 110 to 210 minutes. The timepoints were assessed using mixed model repeated measures.
Change from baseline comparison of reproxalap to vehicle for Schirmer test (0 to 35 mm). Higher scores represent greater tear production. The least squares mean (standard error) was derived from a mixed model repeated measures analysis of change from baseline, with baseline as a covariate, and time point and treatment group as factors.
Comparison of reproxalap to vehicle for number of subject eyes that are Schirmer test responders (10 millimeters or more increase from baseline). A generalized estimating equation analysis was performed with baseline as a covariate, and time point and treatment group as factors.
The proportion of 6-week safety population subjects that experience at least one visual acuity TE-SAE decrease (defined as an increase of 0.22 or greater in logMAR score) categorized as probably or definitely related to test article.
The proportion of 6-week safety population subjects that experience at least one intraocular pressure TE-SAE (increase from baseline of greater than or equal to 10 mmHg and intraocular pressure of greater than 25 mmHg) categorized as probably or definitely related to test article.
The proportion of 6-week safety population subjects that experience at least one cornea-related TE-SAE (detected via slit-lamp examination) categorized as probably or definitely related to test article.
The proportion 6-week safety population subjects that experience at least one retinal TE-SAE (detected via fundoscopy) categorized as probably or definitely related to test article.
The proportion of 12-month safety population subjects that experience at least one visual acuity TE-SAE (defined as an increase of 0.22 or greater in logMAR score) categorized as probably or definitely related to test article.
Change from baseline comparison of reproxalap to vehicle for ocular itching on a 0 to 4 scale ( 0 = none, 4 = severe). The treatment comparison was performed using a mixed model repeated measures approach for a crossover trial with two treatment periods. The model included time point, treatment, treatment period, treatment sequence, and interaction between time point and treatment as fixed effects, and subject nested within treatment sequence as a repeated measure.
Subject-reported ocular itching score area under the curve from 10 to 60 minutes post allergen challenge using a 0 to 4 scale (0 = none, 4 = severe) was assessed. The least squares mean was derived from analysis of covariance of area under the curve with baseline as a covariate and treatment as a fixed effect The possible range for area under the curve least squares mean is 0 to 100, where a lower score is better.
Change from baseline comparison of reproxalap to vehicle for conjunctival redness assessed on a 0 to 4 scale (0 = none, 4 = extremely severe). The least squares mean (95% confidence interval) was derived from mixed model repeated measure for change from baseline included baseline as a covariate, and treatment, period, sequence, and time point as factors.
Ocular discomfort (0 = none, 10 = extremely severe) was reported by patients in a dry eye chamber. Change from baseline was analyzed using a mixed model repeated measures (MMRM) analysis, with baseline as a covariate, and treatment and intra-chamber time point as factors.
Ocular itching (0 = none, 10 = extremely severe) was reported by patients in a dry eye chamber. Change from baseline was analyzed using a MMRM analysis, with baseline as a covariate, and treatment and intra-chamber time point as factors.
Change from baseline comparison of reproxalap to vehicle for subject-reported ocular dryness score VAS (0 = no discomfort, 100 = maximal discomfort), where a high score means a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measure for change from baseline included baseline, treatment group, and nominal time point as fixed effects.
Change from baseline comparison of reproxalap to vehicle for Schirmer test on a millimeter line (0 = none, 35 = maximum), where a shorter length indicates a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measure for change from baseline included baseline and treatment group as fixed effects.
Change from baseline comparison of reproxalap to vehicle for conjunctival redness on a 0 to 4 scale ( 0 = normal, 4 = prominent), where a high 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 included baseline, site, treatment group, and nominal time point as fixed effects.
Change from baseline comparison of ADX-102 to Vehicle on the Ora Calibra® Discomfort \& 4-Symptom Questionnaire (0 = least, 5 = most) for dryness across all time points. The intervention was administered bilaterally. The Least Squares Mean (Standard Error) was derived from Mixed Model Repeated Measure for change from baseline calculated using baseline score, visit, treatment, and visit-by-treatment interaction.
Mean change from baseline in ocular itching score using a 0 to 4 scale (0 = least, 4 = most) was assessed on days when peak pollen counts meet or exceed the American Academy of Allergy Asthma \& Immunology weed pollen scale 95th percentile (325 grains per cubic meter). The least squares mean (standard error) was derived from analysis of covariance with baseline, treatment, and day as factors.
| Arm | Type | Description |
|---|---|---|
| Reproxalap Ophthalmic Solution (0.25%) administered six times over two consecutive days | EXPERIMENTAL | - |
| Vehicle Ophthalmic Solution administered six times over two consecutive days | PLACEBO_COMPARATOR | - |
| Reproxalap Ophthalmic Solution (0.25%) | EXPERIMENTAL | - |
| Vehicle Ophthalmic Solution | PLACEBO_COMPARATOR | - |
| Reproxalap Ophthalmic Solution (0.25%) administered 7 times over two consecutive days | EXPERIMENTAL | - |
| Vehicle Ophthalmic Solution administered 7 times over two consecutive days | PLACEBO_COMPARATOR | - |
| Reproxalap (0.25%) for six weeks | EXPERIMENTAL | Reproxalap four times daily (QID) for four weeks followed by two times daily (BID) for two weeks |
| Vehicle for six weeks | PLACEBO_COMPARATOR | Vehicle QID for four weeks followed by BID for two weeks |
| Reproxalap (0.25%) for 12 months | EXPERIMENTAL | Reproxalap (0.25%) QID for four weeks followed by BID for 11 months |
| Vehicle for 12 months | PLACEBO_COMPARATOR | Vehicle QID for four weeks followed by BID for 11 months |
| Reproxalap Ophthalmic Solution (0.5%) | EXPERIMENTAL | - |
| Xiidra® (5% lifitegrast ophthalmic solution) | ACTIVE_COMPARATOR | Single dose |
| Reproxalap Ophthalmic Solution (0.25%) administered 7 times over two consecutive days. | EXPERIMENTAL | - |
| Vehicle Ophthalmic Solution administered 7 times over two consecutive days. | PLACEBO_COMPARATOR | - |
| Reproxalap Ophthalmic Solution (0.25%) administered QID over two consecutive days. | EXPERIMENTAL | - |
| Vehicle Ophthalmic Solution administered over two consecutive days. | PLACEBO_COMPARATOR | - |
| Reproxalap Ophthalmic Solution (0.1%) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Reproxalap Ophthalmic Solution (0.25%) | DRUG | Reproxalap Ophthalmic Solution (0.25%) administered six times over two consecutive days |
| Vehicle Ophthalmic Solution | DRUG | Vehicle Ophthalmic Solution administered six times over two consecutive days |
| Placebo Comparator | DRUG | Vehicle Ophthalmic Solution administered for six weeks (QID for four weeks then BID for two weeks). |
| Reproxalap Ophthalmic Solution (0.5%) | DRUG | Reproxalap Ophthalmic Solution (0.5%) administered once. |
| Xiidra® (5% lifitegrast ophthalmic solution) | DRUG | Xiidra® (5% lifitegrast ophthalmic solution) dosed once |
| Vehicle Opthalmic Solution | DRUG | Vehicle Ophthalmic Solution administered over two consecutive days (Day one pre-dry eye chamber and Day two dry eye chamber assessment). |
| Reproxalap Ophthalmic Solution (0.1%) | DRUG | Reproxalap Ophthalmic Solution (0.1%) administered for approximately twelve weeks. |
Inclusion Criteria: * 18 years of age (either gender and any race) * Ability to provide written informed consent and sign the Health Information Portability and Accountability Act form * Reported history of ocular discomfort associated with dry eye disease for at least 6 months prior to Visit 1 * R...
Reproxalap is an investigational small molecule being developed for the treatment of dry eye disease, including dry eye syndrome and allergic conjunctivitis. It is administered as an ophthalmic solution and is currently in Phase 3 clinical development for these ophthalmologic conditions.
Reproxalap is being developed by Aldeyra Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ALDX. The company is conducting clinical trials of Reproxalap ophthalmic solution in the United States for the treatment of dry eye disease.
Reproxalap is in Phase 3 clinical development for dry eye disease. While earlier Phase 2 trials have been completed, the most recent trials, including those with enrollment of 757 and 421 participants, are Phase 3 studies. Reproxalap is investigational and has not been approved by the FDA.
Reproxalap has been studied in four completed clinical trials in the United States. These include NCT03404115, a Phase 2 trial with 300 participants, and three Phase 3 trials: NCT04735393 with 757 participants, NCT06424444 with 421 participants, and NCT06493604 with 116 participants, all evaluating the safety and efficacy of Reproxalap in dry eye disease.
No, Reproxalap is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for dry eye disease. All four clinical trials of Reproxalap have been completed, but the drug remains under investigation and has not yet received regulatory approval for any indication.
Reproxalap is a small molecule that works by reducing levels of reactive aldehydes, which are elevated in ocular inflammation and contribute to dry eye disease. By binding to these aldehydes, Reproxalap aims to alleviate the signs and symptoms of dry eye and allergic conjunctivitis.