https://finance.yahoo.com/news/aldeyra-therapeutics-reports-full-2022-120000585.html
Some good progress this company has made in the last 8 months with their retinal studies and medications. I'm excited as this company has had a good slow growth based off their studies and not pump and dumps. Will be a good alternative to other dry eye disease as well.
Recent Corporate Highlights
- Priority Review Designation Granted for NDA of ADX-2191 for the Treatment of Primary Vitreoretinal Lymphoma: The New Drug Application (NDA) submission of ADX‑2191 (methotrexate injection, USP), an investigational drug candidate, is supported by a combination of published literature on the safety and efficacy of intravitreal methotrexate for the treatment of primary vitreoretinal lymphoma and safety data from the recently completed Phase 3 GUARD Trial of ADX‑2191 for the prevention of proliferative vitreoretinopathy. During the Phase 3 GUARD Trial, no safety signals were observed, and ADX‑2191 was well tolerated; there were no observed treatment-emergent serious adverse events. The most common adverse event associated with ADX‑2191 treatment was punctate keratitis, a frequently observed side effect of intravitreal methotrexate, that was most commonly mild in severity. The U.S. Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) date of June 21, 2023. The FDA noted that no potential filing review issues had been identified.
- FDA Accepted for Review NDA of Reproxalap for the Treatment of Signs and Symptoms of Dry Eye Disease: The NDA submission of topical ocular reproxalap, a first-in-class investigational new drug candidate, is supported by previously announced safety and efficacy results from five adequate and well-controlled clinical trials encompassing data for ocular dryness symptom score, ocular redness, Schirmer test, and Schirmer test ≥10 mm responder analysis. The NDA includes activity ranging from within minutes of drug administration to up to 12 weeks of treatment, crossover and parallel-group clinical trial designs, and assessment in dry eye chamber challenge and natural environment settings. The FDA assigned a PDUFA date of November 23, 2023. The FDA noted that no potential filing review issues had been identified, and that an advisory committee meeting was not currently planned.
- Positive Top-Line Results Announced from the 12-Month Safety Clinical Trial of Reproxalap in Dry Eye Disease: Treatment-related serious adverse events in ocular safety were not observed in any patient. Ocular safety events were similar across reproxalap and vehicle treatment groups. Consistent with prior experience with reproxalap and other topical ocular medications, the most common adverse event in reproxalap-treated patients was mild and transient instillation site irritation. In a post-hoc analysis, reproxalap was statistically superior to vehicle in improvement from baseline in distance visual acuity, potentially representing the first demonstration of improvement in distance visual acuity with a topically administered therapy.
submitted by /u/ungratefulanimal
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