AbbVie Inc. and Aldeyra Therapeutics, Inc. have entered into an exclusive option agreement for 0.25% reproxalap ophthalmic solution (reproxalap).
Refresh me on this candidate.
The investigational new drug candidate is Aldeyra’s first-in-class, small-molecule modulator of reactive aldehyde species (RASP).
RASP has been known to be elevated in ocular and systemic inflammatory disease as well as cause decreased tear production, eye redness, change in lipid tear composition, and increased ocular inflammation.
To note, the FDA accepted a new drug application (NDA) for reproxalap earlier this year for the treatment of dry eye disease (DED).
How quickly can it work?
Per previous study data—including from five well-controlled clinical trials, a 12-month safety study, and a phase 3 trial—reproxalap has illustrated a reduction in the signs and symptoms of DED ranging from within minutes of administration to up to 12 weeks.
Positive topline data was reported from each of those trials.
Gotcha. But hold up … didn’t we just hear an update about it?
Indeed we did. Last month, Aldeyra disclosed that a late-cycle review meeting with the FDA identified major issues with the candidate’s clinical data.
And let’s remember: this was just a month out from reproxalap’s Prescription Fee Drug User Act (PDUFA) deadline of November 23, 2023.
Click here for those details, including more context surrounding the FDA’s about the FDA’s concerns.
Okay… now this new agreement.
Under the terms, AbbVie has the option to acquire a co-license for the development, manufacturing, and commercialization of reproxalap in the United States.
And on top of that, the company has the exclusive license for the same rights to reproxalap outside of the U.S.
What’s in it for Aldeyra?
Per the agreement, Aldeyra will be given a $1 million non-refundable option fee as well as an upfront payment of $100 million fewer option fees, dependent on whether AbbVie chooses to use its option.
What about any milestone payments?
Those are included, too:Aldeyra would also be eligible to receive up to $300 million in regulatory and commercial milestone payments—“inclusive of a $100 million milestone payment upon [FDA] approval of reproxalap in dry eye disease,” according to the company.
And in terms of commercialization profits?
In the U.S., both companies would share commercialization profits and losses in a 60% (AbbVie) / 40% (Aldeyra) split.
Outside the U.S., “Aldeyra would be eligible to receive tiered royalties on net sales.”
Anything else?
Oh yes. About that option license for AbbVie… the company will also be granted the right of first negotiation for any compound Alderya owns or controls that relate to the ocular surface within the ophthalmic space.
Lastly, this option is in addition to AbbVie also having the right to review data for any other of Aldeyra’s compounds (owned or controlled) within the ophthalmology and immunology therapeutic areas before that data is shared with a third party.
So what exactly are the FDA’s concerns about reproxalap?
Good question … and it’s tough to say.
Since those concerns were made public last month, all’s been quiet in terms of next steps for reproxalap’s journey to marketing approval.
But with that November 23, 2023, PDUFA date fast approaching, time will tell.