Author(s): Emily Kaiser Maharjan
Key Takeaways
- Aldeyra’s phase 3 trial of reproxalap showed statistical superiority in reducing ocular discomfort compared to the vehicle, supporting NDA resubmission.
- The unique chamber trial design, controlling environmental factors, sets Aldeyra’s study apart from traditional dry eye trials.
- No safety signals or treatment-related discontinuations were reported, with reproxalap being well-tolerated.
- Aldeyra plans to resubmit the NDA in mid-2025, addressing FDA concerns from a previous Complete Response Letter.
Aldeyra Therapeutics has achieved primary end point in one of their phase 3 trials of reproxalap for the treatment of dry eye disease, which the company will include in the resubmission of the new drug application (NDA) for the therapeutic candidate.1 The dry eye chamber trial was statistically superior to the vehicle in terms of ocular discomfort and while the field trial missed statistical significance for the primary end point, it was consistent with previous field trials and will be submitted with the NDA submission as supportive data. The company intends to resubmit its NDA in mid-2025, pending a Type A meeting with the FDA.
Source: Ophthalmology Times
read more: Aldeyra Therapeutics hits primary end point in 1 of 2 phase 3 trials for reproxalap