The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Aldeyra Therapeutics regarding its new drug application (NDA) of reproxalap, requesting additional clinical trial data to show the drug’s efficacy.

The CRL stated that “at least one additional adequate and well-controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye” should be conducted. Citing that the data submitted as part of the NDA “did not demonstrate efficacy in treating ocular symptoms associated with dry eyes”, as per a 27 November press release.

Aldeyra was quick to add that “no safety or manufacturing issues with reproxalap were identified”. On 16 November, the US-based company submitted a special protocol assessment (SPA) to the FDA for a proposed chamber crossover clinical trial similar to a previous chamber crossover Phase II trial (NCT05424549). The feedback on the SPA review cycle is expected in December, with the topline results expected in H1 2024, depending on if SPA gets approved.

The Phase II chamber crossover trial enrolled 63 participants and met its primary endpoints by showing a significant reduction in conjunctival redness in a dry eye chamber and an improvement in tear production, measured using the Schirmer test, as per a 12 July 2022 press release. The trial also met its secondary endpoint of a Schirmer test score ≥ 10mm, signifying normal tear production.

Aldeyra expects the proposed chamber trial to cost under $2m. The company also reported cash reserves of $143m, as of 30 September. The dry eye disease market is forecasted to generate $10bn in sales across the seven major markets in 2028, as per GlobalData analysis.

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Pursuant to SPA approval by the FDA and positive trial results from the proposed trial, Aldeyra plans to resubmit its NDA in H1 2024. The company also plans to include a draft label “describing chronic and acute symptomatic benefit, in addition to acute reduction in ocular redness of reproxalap” with the new NDA.

Aldeyra has also conducted additional Phase III trials evaluating reproxalap in dry eye disease patients. The drug failed to meet its primary endpoint of reduction in conjunctival redness in the Phase III TRANQUILITY trial (NCT04674358). However, reproxalap was able to show statistically significant improvement in the Schirmer test in both Phase III TRANQUILITY and TRANQUILITY-2 (NCT05062330) trials.

This month, Aldeyra signed an exclusive option agreement for reproxalap with AbbVie, with both sharing the development, manufacture, and commercialisation rights to the drug in the US. In addition, AbbVie holds an exclusive licence to these rights outside the US and Aldeyra will receive tiered royalties on net sales if AbbVie chooses to exercise the option.

Reproxalap is also being evaluated as a treatment for allergic conjunctivitis. In June, the company reported positive data from the Phase III INVIGORATE-2 trial (NCT05234554). In light of the trial meeting its primary endpoint and all the secondary endpoints, the company plans to hold a Type C meeting with the FDA regarding the NDA submission in H1 2024.