Aldeyra Therapeutics advocates for expanded access for ADX-2191
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Key takeaways:
- The new drug application for ADX-2191 for the treatment of primary vitreoretinal lymphoma was not approved.
- Aldeyra will seek accessibility under an expanded access program.
Aldeyra Therapeutics will seek to make its investigational drug candidate ADX-2191 available to patients with primary vitreoretinal lymphoma under an FDA expanded access program, according to a press release.
The request for a discussion with the FDA follows a recent negative response in a complete response letter regarding the new drug application for ADX-2191, a non-compounded vitreous-compatible formulation of methotrexate, based on “lack of substantial evidence of effectiveness” from “adequate and well-controlled investigations,” the release said.
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Based on prior discussions with the FDA, Aldeyra did not conduct clinical trials of ADX-2191 in primary vitreoretinal lymphoma (PVRL).
“We do not currently believe that randomized clinical trials of ADX-2191 in PVRL, a rare and fatal cancer with no approved therapy, are feasible,” Todd C. Brady, MD, PhD, president and CEO of Aldeyra Therapeutics, said in the release.
The need for shortening the pathway to make ADX-2191 accessible is dictated by the current shortage of methotrexate, currently used as a compounded intravitreal injection for PVRL, the company said. Expanded access, which is granted to investigational drugs when no other therapies are available, would provide patients with PVRL with a safe alternative treatment option, with the added benefit of avoiding the risks potentially associated with the injection of compounded formulations.
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