Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NS2 · 2 trials · 3 indications
Mean change from baseline in ocular itching score using a 0 to 4 scale (0 = none, 4 = severe) on Day 14, 60 minutes into the allergen challenge. The least squares mean (standard error) was derived from analysis of covariance (ANCOVA) with baseline as a covariate and treatment group as a factor.
Change from baseline comparison of NS2 ophthalmic drops (0.5%), NS2 (0.5%) and Pred Forte® (0.1%) ophthalmic drops, and Pred Forte® (1%) ophthalmic drops on an anterior chamber cell grade scale of 0 to 4 (0 = absent, 4 = severe). The least squares mean (standard error) was derived from analysis of covariance (ANCOVA) with baseline as a covariate and treatment group as a factor.
| Arm | Type | Description |
|---|---|---|
| NS2 Ophthalmic Drops (0.5%) | EXPERIMENTAL | NS2 Ophthalmic Drops (0.5%) |
| NS2 Ophthalmic Drops Vehicle (0.0%) | SHAM_COMPARATOR | NS2 Ophthalmic Drops Vehicle (0.0%) control |
| NS2 | EXPERIMENTAL | NS2 ophthalmic drops (0.5%) in the affected eye |
| NS2 and Pred Forte | EXPERIMENTAL | NS2 ophthalmic drops (0.5%) and Prednisolone acetate ophthalmic suspension (1%) in the affected eye |
| Pred Forte | ACTIVE_COMPARATOR | Prednisolone acetate ophthalmic suspension (1%) in the affected eye |
| Name | Type | Description |
|---|---|---|
| NS2 Ophthalmic Drops (0.5%) | DRUG | - |
| NS2 Ophthalmic Drops Vehicle (0.0%) | DRUG | - |
| NS2 | DRUG | NS2 ophthalmic drops (0.5%) |
| Prednisolone acetate ophthalmic suspension (1%) | DRUG | - |
Inclusion Criteria: * Graded conjunctival redness in at least one region (nasal or temporal) in each eye at any one time point (not necessarily the same time point) post-CAPT (Conjunctival Allergen Provocation Test) of \>2 * Graded ocular itching at any one time point * Visual acuity of at least 20...
NS2 is an investigational small molecule being developed for the treatment of non-infectious anterior uveitis and allergic conjunctivitis. It is administered as an ophthalmic formulation for these ocular inflammatory conditions. NS2 is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
NS2 is being developed by Aldeyra Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ALDX. Aldeyra is focused on developing innovative therapies for inflammatory and metabolic diseases, with NS2 being one of its pipeline candidates for ophthalmology indications.
NS2 is in Phase 2 clinical development. Two Phase 2 trials have been completed: one in patients with anterior uveitis (NCT02406209) and another in subjects with allergic conjunctivitis (NCT02578914). NS2 is an investigational drug and has not received FDA approval.
NS2 has completed two Phase 2 clinical trials. NCT02406209 was a safety and efficacy study in 45 patients with non-infectious anterior uveitis in the United States. NCT02578914 was a safety and activity study in 100 subjects with allergic conjunctivitis and seasonal allergies in Canada. Both trials were randomized, double-blind, and sham-controlled.
NS2 is not known to have alternative names. It is a distinct investigational compound developed by Aldeyra Therapeutics. No other names for NS2 have been reported in clinical trial registrations or company communications.