Aldeyra Therapeutics (NASDAQ:ALDX) Chief Executive Todd Brady said the company expects near-term feedback from the U.S. Food and Drug Administration on its dry eye disease candidate reproxalap, following a third complete response letter tied to efficacy questions.
Speaking at a Jefferies fireside chat with biotech analyst Amin Makarem, Brady described Aldeyra as an immunology company with a pipeline that began in front-of-the-eye diseases, including dry eye disease and allergic conjunctivitis. He said reproxalap remains an NDA-stage product and is the company’s primary near-term focus.
Reproxalap regulatory path centers on FDA Type A meeting
Brady said Aldeyra has received three complete response letters, or CRLs, from the FDA for reproxalap in dry eye disease. According to Brady, the most recent CRL, received in March, did not request another trial but questioned whether the company had demonstrated the “totality” of evidence supporting approval.
“The latest CRL didn’t say run more trials. It said prove totality,” Brady said.
Brady said the company is days away from receiving preliminary FDA comments ahead of a Type A meeting, which is used to discuss a rejection and possible paths forward. Aldeyra expects to receive meeting minutes 30 days after the meeting and intends to hold a conference call to update investors on the FDA reviews, the Type A meeting feedback and the company’s next steps.
Brady said one possible outcome is that the FDA reconsiders after reviewing Aldeyra’s meta-analyses, pooled data and assessment of the totality of evidence, potentially leading to label discussions. However, he characterized that as a “low probability” based on prior interactions with the division.
If the FDA maintains its position, Brady said Aldeyra would consider a formal appeal through the FDA’s Formal Dispute Resolution Request process. He noted that an appeal would go to the Office of New Drugs because the signatory office on the rejection is the Office of Specialty Medicine, above the ophthalmology division.
Dispute over trial interpretation
Brady said the FDA identified five trials in the CRL, two of which Aldeyra agrees were not statistically significant. He said the company disagrees with the FDA’s view on three other trials, citing different issues raised by the agency, including a baseline imbalance in one study.
Brady said Aldeyra has laid out its trial data and primary endpoints in its corporate deck, including the company’s view and the FDA’s view of the results. He said investors can assess the company’s argument based on that information.
Asked whether the FDA could require another trial, Brady said he does not expect the reviewing division to do so because it did not request one in the CRL and, according to Brady, division leadership told him the agency wanted to give Aldeyra the opportunity to demonstrate totality without running a new study.
If additional trials are ultimately required, Brady said Aldeyra’s strongest results have been on the Schirmer test, which measures tear production. He said those studies could be short, two-week or two-dose trials, and estimated each would cost $5 million or less.
Commercial positioning tied to acute activity
Brady said reproxalap’s potential commercial opportunity, if approved, would be tied to its acute activity in dry eye disease, including effects seen within minutes in a controlled dry eye chamber setting.
“No other drug’s ever done that,” Brady said, adding that Aldeyra views reproxalap as differentiated because of potential activity during flare settings.
He also said redness could be commercially important if reflected in labeling, describing it as the sign of dry eye disease that patients can see themselves.
Aldeyra has a partnership with AbbVie involving an option on reproxalap. Brady said the arrangement includes a $200 million upfront payment if AbbVie opts in after approval, additional potential milestones and a 60/40 profit-and-loss split between AbbVie and Aldeyra. He said AbbVie has the right to be involved in correspondence and is “intimately involved” in the current clinical and regulatory process.
Pipeline includes ocular lymphoma, atopic dermatitis and dry AMD
Beyond dry eye, Brady highlighted an NDA-stage ocular lymphoma asset: an ocular injection formulation of methotrexate. He said methotrexate is the standard of care, but there is no methotrexate product approved for lymphoma in the eye.
Brady said Aldeyra previously submitted an NDA for the ocular lymphoma program based on literature after FDA encouragement, but the application was rejected. The company is now discussing with the FDA what additional evidence may be needed. Brady said Aldeyra has a Special Protocol Assessment agreement in ocular lymphoma but is evaluating whether that is the right trial to run and whether other FDA divisions, including oncology, should be involved.
Brady also said investors have shown interest in Aldeyra’s atopic dermatitis program, particularly given unmet need in children and mild disease. He said the company has an oral RASP inhibitor that recently completed Phase 1 testing. In dry age-related macular degeneration, Brady said Aldeyra hopes to enter the clinic next year, assuming the program progresses as planned.
Cash runway expected into second half of 2028
Brady said Aldeyra reported $65 million in cash at the end of the last quarter and had seven or eight employees. He said the company also had $15 million in debt that has since been paid down, leaving roughly $50 million in cash after the debt repayment.
The company has guided that its cash runway extends into the second half of 2028. Brady said Aldeyra has enough capital to continue the reproxalap regulatory process, potentially run additional dry eye trials if needed and continue discussions with the FDA on ocular lymphoma.
“I don’t think from a cash standpoint or an infrastructure standpoint we’re at risk of anything in the near term,” Brady said.
About Aldeyra Therapeutics (NASDAQ:ALDX)
Aldeyra Therapeutics, Inc is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel small molecule therapies for immune-mediated diseases. The company's research efforts center on targeted alkenals, a class of reactive aldehyde species that play a key role in inflammatory pathways. By selectively modulating these pathways, Aldeyra aims to address both ocular and systemic indications with high unmet medical need.
The company's lead product candidate, reproxalap, is being investigated in several ophthalmic disorders, including dry eye disease, allergic conjunctivitis and non-infectious anterior uveitis.
This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to contact@marketbeat.com.
The article "Aldeyra Therapeutics Eyes FDA Feedback as Dry Eye Drug Faces Make-or-Break Moment" first appeared on MarketBeat.
