As expected, Aldeyra Therapeutics Inc. received a complete response letter (CRL) from the U.S. FDA regarding its NDA for reproxalap in dry eye disease, with the agency requiring “at least one” additional study to prove efficacy of the reactive aldehyde species, or RASP, modulator.
Investors awaiting the announcement of a partnering deal for RASP modulator reproxalap ahead of the drug’s Nov. 23 PDUFA date were in for a rude awakening, as Aldeyra Therapeutics Inc. disclosed that the U.S. FDA had raised issues with the NDA, putting its imminent approval in dry eye disease in doubt. The update, disclosed in an SEC filing, sent shares (NASDAQ:ALDX) sinking 66%, or $3.60, to close Oct. 16 at $1.83.
In its newly issued complete response letter (CRL) to Aldeyra Therapeutics Inc., the U.S. FDA said there’s just not enough evidence of efficacy right now to approve ADX-2191, an injectable vitreous-compatible formulation of methotrexate to treat primary vitreoretinal lymphoma (PVRL).
With the drug already under review by the U.S. FDA for dry eye disease (DED), Aldeyra Therapeutics Inc.’s reproxalap hit statistical significance in the second phase III study for allergic conjunctivitis (AC), and the firm is mulling what CEO Todd Brady called the “high-class problem” of how to best commercialize the product. A partner may help puzzle that out.
Aldeyra Therapeutics Inc. is eyeing the start of clinical trials with reactive aldehyde species (RASP) modulators ADX-246 for systemic immune-mediated diseases and ADX-248 for geographic atrophy.
Aldeyra Therapeutics Inc. CEO Todd Brady said that, with new data from a crossover trial with reproxalap in dry eye disease (DED), the question of “approvability has been put to bed,” and the company plans a pre-NDA meeting with U.S. FDA in the third quarter of this year.
With the memory of Dec. 20’s stock-denting, top-line phase III fizzle by Aldeyra Therapeutics Inc. in dry eye disease (DED) still fresh, Palatin Technologies Inc. is launching a late-stage effort in the same indication. Aldeyra offered data from the Tranquility trial with reproxalap – a small-molecule, immune-modulating covalent inhibitor of reactive aldehyde species, known as RASP, formulated as an ophthalmic solution – that showed a miss on the primary endpoint of ocular redness.
Lexington, Mass.-based Aldeyra Therapeutics Inc.’s phase III win in the study called Invigorate with reproxalap for allergic conjunctivitis (AC) restarted speculation about odds of the drug, a small-molecule, immune-modulating covalent inhibitor of reactive aldehyde species (RASP), to treat dry eye disease (DED). “I do think there is potential read-through,” CEO Todd Brady said, especially with regard to the redness endpoint. A six-week safety study necessary before going to the FDA has not yet started, he told investors during a conference call. “That will require some discussions with the FDA, but I do not think, given the length of the trial, the safety study would impair our guidance of potentially filing NDAs by the end of this year.”
Saying it’s too early to gauge the potential economic benefit of a marketed COVID-19 therapy for his firm, Aldeyra Therapeutics Inc. CEO Todd Brady cited “a strong feeling of altruism” among researchers addressing the crisis, as they turn over discoveries likely to be helpful beyond it.