Aldeyra Therapeutics, Inc. · NASDAQ:ALDX
Aldeyra Therapeutics — Corporate Update (November 2023)
7 slides from Aldeyra Therapeutics's corporate update, Nov 28, 2023
Slide 1: Reproxalap for the Treatment of Dry Eye Disease: Regulatory Update
Exhibit 99.1 C O N F E R E N C E C A L L Reproxalap for the Treatment of Dry Eye Disease Regulatory Update November 28, 2023 Nasdaq: ALDX © Aldeyra Therapeutics, Inc. 2023
Slide 2: Disclaimers and Forward-Looking Statements
2 Disclaimers and Forward-Looking Statements This presentation and various remarks which may be made during this presentation contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934, as amend
Slide 3: Aldeyra Received a Complete Response Letter for Reproxalap for the Treatment of Dry Eye Disease
3 Aldeyra Received a Complete Response Letter for Reproxalap for the Treatment of Dry Eye Disease The letter stated that the NDA did not demonstrate “efficacy in treating ocular symptoms associated with dry eyes“ and that “at least one additional adequate and well-controlled study to demonstrate a p
Slide 4: Aldeyra Has Proposed to the FDA a Symptom Trial to Satisfy Efficacy Requirements
4 Aldeyra Has Proposed to the FDA a Symptom Trial to Satisfy Efficacy Requirements for Reproxalap in Dry Eye Disease A Special Protocol Assessment (SPA) was submitted to the FDA on November 16, 2023, for a dry eye disease chamber crossover clinical trial (the proposed trial) similar to the crossover
Slide 5: The Proposed Crossover Chamber Trial Design is Materially Identical to the Previously Completed Dry Eye Chamber Trial
5 The Proposed Crossover Chamber Trial Design is Materially Identical to the Previously Completed Dry Eye Chamber Trial Treatment Visits Randomized, double-masked, crossover, vehicle- Design Each treatment visit represents Day 1 (pre-chamber) and Day 2 (chamber) visits. controlled, single-center 0.2
Slide 6: Acute Improvement Was Demonstrated for All Symptoms Assessed in the Previously Completed Trial
6 Acute Improvement Was Demonstrated for All Symptoms Assessed in the Previously Completed Dry Eye Chamber Crossover Trial Dryness Discomfort Grittiness Stinging Burning Itching (collected pre/post chamber only) Symptoms were assessed as secondary endpoints that were not multiplicity controlled. P v
Slide 7: Aldeyra is Well Positioned to Execute on Potential NDA Resubmission Milestones
7 Aldeyra is Well Positioned to Execute on Potential NDA Resubmission Milestones With $143M in cash, cash equivalents, and marketable securities as of September 30, 2023, Aldeyra is well positioned to execute on potential NDA resubmission milestones: SPA feedback anticipated in December 2023 Dry eye
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