Aldeyra Therapeutics, Inc. plans to resubmit reproxalap for US Food and Drug Administration approval to treat dry eye disease based on the positive outcome of a Phase III dye eye chamber clinical trial that the agency required before it would reconsider the company’s new drug application (NDA). Aldeyra plans to refile the NDA before the end of 2024 and expects a six-month review as it promised investors back in March when the FDA cleared the design of its chamber trial design.
Aldeyra Readies Reproxalap For Dry Eye Refiling After Chamber Study Success
Awaiting Word From AbbVie On Option Exercise
The company said earlier this year that it would resubmit reproxalap for US FDA approval before the end of 2024 once it completed another Phase III trial and is eyeing both acute and chronic use.
More from Clinical Trials
• By
RemeGen is planning to complete enrolment in the global Phase III RemeMG study with telitacicept in generalized myasthenia gravis by the end of 2025 or early 2026. The Chinese firm has already sidelined two other global Phase III trials with the molecule to prioritize the indication.
• By
The biotech is banking on itolizumab’s longer-term efficacy as well as unmet need in frontline acute graft-versus-host disease as it prepares to meet with the FDA.
• By
The head of the Spanish medical dermatology specialist told Scrip that maintaining the status quo will only result in the continent’s life sciences sector slipping further behind the US and China.
• By
With its exon 53-skipping candidate already showing promise in 24-week data, Wave now has 48-week data showing improvements in muscle health and functional outcomes.
More from R&D
• By
The Danish firm is spending nearly $580m to repurchase up to 2.2 million shares
• By
The Texas-based firm is giving up on the investigational Alzheimer’s therapy after a second Phase III failure left it with nowhere to go in the disease.
• By
A decision from the FDA is due by 28 September.