MedPath

Reproxalap

Generic Name
Reproxalap
Brand Names
-
Drug Type
Small Molecule
Chemical Formula
C12H13ClN2O
CAS Number
916056-79-6
Unique Ingredient Identifier
F0GIZ22IJH
Background

Reproxalap (previously ADX 102 or NS-2) is a small molecule inhibitor being developed by Aldeyra Therapeutics investigated against dry eye disease, allergic conjunctivitis, noninfectious anterior uveitis, and Sjögren-Larsson syndrome. NS-2 has orphan drug status due to it being investigated for treatment of Sjogren-Larsson syndrome.

Associated Conditions
-
Associated Therapies
-
optometrytimes.com
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What happened in optometry this week: September 30 - October 4

Aldeyra Therapeutics resubmits NDA for reproxalap for DED treatment; Aviceda Therapeutics completes phase 2b SIGLEC study enrollment for AVD-104 for GA secondary to AMD; MiYOSMART spectacle lens users continue use for up to 8 years; Bausch + Lomb launches Opal digital marketplace for eye care practices; color vision deficiency may impact choroidal diagnosis differentiation.

NDA Resubmitted for Dry Eye Treatment Reproxalap

Aldeyra Therapeutics resubmits NDA to FDA for reproxalap, a potential treatment for dry eye and allergic conjunctivitis, including positive phase 3 trial results. Reproxalap, a first-in-class RASP modulator, aims to reduce dry eye symptoms and ocular redness, with over 2,500 patients tested and mild site irritation as the only observed safety concern.
medthority.com
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Aldeyra Therapeutics resubmits reproxalap new drug application to FDA

Aldeyra resubmitted data for reproxalap, showing positive results in reducing dry eye symptoms and ocular redness, with potential as the first chronic-use therapy for dry eye disease. A Phase III trial demonstrated reproxalap's superiority in reducing ocular discomfort, indicating a rapid clinical effect.
drugs.com
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Aldeyra Therapeutics Resubmits Reproxalap New Drug Application for the Treatment of Dry Eye Disease

Aldeyra Therapeutics resubmits NDA for reproxalap, an investigational drug for dry eye disease, including positive trial results and a draft label reflecting acute and chronic symptom reduction.
optometrytimes.com
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Aldeyra Therapeutics resubmits NDA for reproxalap for DED signs and symptoms treatment

Aldeyra Therapeutics resubmits NDA to FDA for reproxalap, a topical ocular treatment for dry eye disease, with data showing acute and chronic symptom reduction and ocular redness improvement. Reproxalap, also in development for allergic conjunctivitis, has been studied in over 2500 patients with no significant safety concerns.
biospace.com
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Aldeyra Therapeutics Resubmits Reproxalap New Drug Application for the Treatment of Dry

Aldeyra Therapeutics resubmits NDA to FDA for reproxalap, a potential dry eye disease therapy, including positive trial results and a draft label reflecting acute and chronic symptom reduction.

Aldeyra Therapeutics resubmits New Drug Application for reproxalap for the treatment of dry eye disease

Aldeyra Therapeutics resubmitted an NDA to the FDA for topical ocular reproxalap, aiming to treat dry eye disease. The new NDA includes results from a Phase 3 trial showing reproxalap's efficacy in reducing ocular discomfort. The FDA previously requested additional studies due to insufficient efficacy evidence in the initial NDA.
hcplive.com
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Aldeyra Resubmits New Drug Application for Reproxalap for Dry Eye Disease

Aldeyra Therapeutics resubmits NDA for reproxalap, a DED treatment, to FDA, including positive Phase 3 trial results addressing ocular discomfort, after previous CRL. Reproxalap, a RASP modulator, showed acute and chronic symptom reduction in dry eye chamber trials.
finance.yahoo.com
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Aldeyra Therapeutics Resubmits Reproxalap New Drug Application for Chronic Dry Eye Disease Therapy

Aldeyra Therapeutics resubmitted an NDA to the FDA for reproxalap, a potential first chronic dry eye disease therapy showing acute symptom and redness reduction. Positive Phase 3 trial results support its rapid clinical effect. FDA review expected within 6 months.
finance.yahoo.com
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Aldeyra Therapeutics Inc (NASDAQ:ALDX) A Bull Case Theory

Aldeyra Therapeutics focuses on RASP inhibition for immune-mediated diseases, with reproxalap as a lead product for dry eye disease. Despite FDA setbacks, a new Phase 3 trial and a partnership with AbbVie offer hope. Aldeyra's pipeline includes treatments for psoriasis and asthma, presenting a biotech investment opportunity.
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