Aldeyra submits NDA for primary vitreoretinal lymphoma treatment
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Aldeyra has submitted a new drug application to the FDA for ADX2191 for the treatment of primary vitreoretinal lymphoma, according to a company press release.
The submission is supported by positive safety data from the phase 3 GUARD Trial that investigated ADX2191 (methotrexate injection, USP) for the prevention of proliferative vitreoretinopathy as well as previously published literature supporting the safety and efficacy of the drug in primary vitreoretinal lymphoma treatment.
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According to the release, there were no observed treatment-emergent serious adverse events associated with ADX2191, with the most common adverse event being punctate keratitis, which was most commonly mild in severity.
ADX-2191 previously received orphan drug designation for the treatment of primary vitreoretinal lymphoma.
“Compounding methotrexate for intravitreal injection, the current standard of care for primary vitreoretinal lymphoma, poses several challenges for physicians and patients, including risk of infection and increased injection volume, potentially leading to ocular hypertension and corneal inflammation,” Todd C. Brady, MD, PhD, president and CEO of Aldeyra, said in the release. “ADX-2191 is a novel formulation of methotrexate that is designed to be vitreous-compatible and has the potential to be the first marketed drug for patients suffering from primary vitreoretinal lymphoma.”
Aldeyra has also requested priority review designation for ADX2191 as part of the submission.
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