Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Reproxalap Ophthalmic Solution (0.25%), ADX-102 Ophthalmic Solution (0.5%), ADX-102, ADX-102 Ophthalmic Lipid Solution (0.5%), ADX-102 Lipid, ADX-102 Ophthalmic Drops (0.5%), ADX-102 1% Topical Dermal Cream (reproxalap), ADX-102 1% Dermal
Reproxalap · 21 trials · 8 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.
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.
Change from baseline using the Visual Index Ichthyosis Severity (VIIS) Scaling Score (0 = least, 4 = most), where a higher value represents a worse outcome, in ADX-102 treated patients
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.
Time to clearance of anterior chamber cells was defined as the time from initiation of study drug to when a cell count of 0 was achieved and maintained (without cell count increases to \>0) to Week 4 and without rescue or discontinuation due to rescue prior to Week 4. Anterior chamber cell count is the number of cells visible within the anterior chamber of the eye, measured using a slit lamp and following SUN (Standardization of Uveitis Nomenclature) where a cell count \<1 is Grade 0 (absent) and a cell count of \>50 is Grade 4+ (severe).
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 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 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 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.
Change from baseline of ADX-102 on ocular discomfort in subjects with dry eye disease using the Ora Calibra® Ocular Discomfort Scale (0 = least, 4 = most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.
Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.
Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.
Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.
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 (0.25%) 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 | - |
| ADX-102 1% Topical Dermal Cream (reproxalap) | EXPERIMENTAL | - |
| Vehicle of ADX-102 Topical Dermal Cream | PLACEBO_COMPARATOR | - |
| Reproxalap Ophthalmic Solution (0.5%) | EXPERIMENTAL | - |
| ADX-102 Ophthalmic Solution (0.5%) | EXPERIMENTAL | - |
| Vehicle of ADX-102 Ophthalmic Solution | PLACEBO_COMPARATOR | - |
| 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 (0.25% Novel Formulation) QID to BID | EXPERIMENTAL | - |
| Reproxalap Ophthalmic Solution (0.1%) | EXPERIMENTAL | - |
| ADX-102 Ophthalmic Solution (0.1%) | EXPERIMENTAL | - |
| ADX-102 Ophthalmic Lipid Solution (0.5%) | EXPERIMENTAL | - |
| ADX-102 Ophthalmic Drops (0.5%) | EXPERIMENTAL | ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks. |
| ADX-102 Ophthalmic Drops (0.1%) | EXPERIMENTAL | ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks. |
| Vehicle of ADX-102 Ophthalmic Drops | PLACEBO_COMPARATOR | Vehicle of ADX-102 Ophthalmic Drops |
| 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 (0.25%) 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 |
| ADX-102 1% Topical Dermal Cream (reproxalap) | DRUG | ADX-102 1% Topical Dermal Cream administered approximately every 24 hours for 6 months. |
| Vehicle of ADX-102 Topical Dermal Cream | DRUG | Vehicle of ADX-102 Topical Dermal Cream administered approximately every 24 hours for 6 months. |
| Reproxalap Ophthalmic Solution (0.5%) | DRUG | Reproxalap Ophthalmic Solution (0.5%) administered once. |
| ADX-102 Ophthalmic Solution (0.5%) | DRUG | ADX-102 Ophthalmic Solution (0.5%) administered for approximately four weeks. |
| Vehicle of ADX-102 Ophthalmic Solution | DRUG | Vehicle of ADX-102 Ophthalmic Solution administered for approximately four weeks. |
| 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 (0.25% Novel Formulation) QID to BID | DRUG | Reproxalap Opthalmic Solution (0.25% Novel Formulation) administered QID for four weeks, followed by BID administration for eight weeks |
| Vehicle Ophthalmic Solution (0.25% Novel Formulation) QID to BID | DRUG | Vehicle Ophthalmic Solution administered QID for four weeks, followed by BID administration for eight weeks |
| Reproxalap Ophthalmic Solution (0.1%) | DRUG | Reproxalap Ophthalmic Solution (0.1%) administered for approximately twelve weeks. |
| ADX-102 Ophthalmic Solution (0.1%) | DRUG | ADX-102 Ophthalmic Solution (0.1%) administered for approximately 4 weeks. |
| ADX-102 Ophthalmic Lipid Solution (0.5%) | DRUG | ADX-102 Ophthalmic Lipid Solution administered for approximately 4 weeks. |
| ADX-102 Ophthalmic Drops (0.5%) | DRUG | ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks. |
| ADX-102 Ophthalmic Drops (0.1%) | DRUG | ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks. |
| Vehicle of ADX-102 Ophthalmic Drops | DRUG | Vehicle of ADX-102 Ophthalmic Drops administered twice in two 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 developed by Aldeyra Therapeutics for immune-mediated ophthalmic and dermatologic conditions. It is being studied in allergic conjunctivitis, dry eye disease, non-infectious anterior uveitis, and Sjogren-Larsson syndrome. Reproxalap is not approved; it remains in clinical development.
Reproxalap is being developed for dry eye disease, also called dry eye syndrome, to reduce ocular inflammation and improve symptoms. It is also under study for allergic conjunctivitis, non-infectious anterior uveitis, and Sjogren-Larsson syndrome. It is investigational and has not been approved for any indication.
Reproxalap targets aldehydes, a class of toxic molecules implicated in inflammation and cellular damage. By binding aldehydes, the drug aims to reduce the inflammatory cascade associated with dry eye disease and other immune-mediated conditions. This mechanism is being evaluated in clinical trials.
Reproxalap is developed by Aldeyra Therapeutics, Inc., a biotechnology company traded on the Nasdaq under the ticker ALDX. Aldeyra is the sponsor of the clinical trials evaluating reproxalap in ophthalmic and dermatologic indications.
Reproxalap is in Phase 3 clinical development. It has completed six trials, including Phase 3 studies in dry eye disease and a Phase 2 trial in dry eye syndromes. Reproxalap is investigational and has not been approved by the FDA for any indication.
Reproxalap has been studied in completed trials including NCT06493604, NCT06424444, and NCT06389214 in dry eye disease, and NCT05424549 in dry eye syndromes. These randomized, double-blind, placebo-controlled trials enrolled a total of 1,532 participants across the United States and Canada.
Yes, Reproxalap is also known as ADX-102. Other names include ADX-102 Ophthalmic Solution (0.5%), ADX-102 Ophthalmic Lipid Solution (0.5%), ADX-102 Ophthalmic Drops (0.5%), and ADX-102 1% Topical Dermal Cream. The ophthalmic solution is also referred to as Reproxalap Ophthalmic Solution (0.25%).