Dry Eye Crossover Study Could Allow Aldeyra A Quick Response To US FDA’s CRL For Reproxalap

Aldeyra’s bid to rely on a single Phase III trial after an initial one failed is rejected by FDA, but firm already has a special protocol assessment under review for a trial that could provide the symptom data it says agency needs to approve the RASP modulator in dry eye. 

Dry eye disease
Aldeyra hopes it can quickly refile its NDA for dry eye disease • Source: Shutterstock

Aldeyra Therapeutics, Inc. revealed on 27 November that it got a complete response letter from the US Food and Drug Administration for its new drug application for reproxalap in dry eye disease, but told an investor call the following day that can quickly meet the agency’s request for additional data on the drug’s efficacy in symptoms of the disease and possibly refile the application by mid-2024.

Key Takeaways
  • Aldeyra got a complete response letter for reproxalap in dry eye disease, but had already been planning on a new trial to obtain needed symptom data.

The CRL requests an additional study demonstrating efficacy in an ocular symptom of dry eye disease, and Aldeyra said it...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Complete Response Letters

Real-Time Release Of CRLs Is US FDA’s Goal, Agency Leaders Affirm

 

The US FDA says its release of complete response letters for products subsequently approved by the agency is just a first step toward releasing rejection letters when they are issued, assuming legal issues can be resolved.

Complete Response Letter Trio Raises Prospect Of Tidal Shift In Regenerative Medicine Regulation

 

Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.

US FDA’s Second Half 2025 User Fee Goals Swing Toward Respiratory Disease

 

The 43 novel agents with user fee goal dates in the remainder of 2025 have fewer oncologics and infectious disease drugs than the first half of the year.

Slowdown: US FDA’s 2025 Novel Approvals Are On Below-Average Pace

 

US FDA's 25 novel approvals in 2025 fell short of the agency's five-year average count, driven by a drop in drugs center approvals; 45 user fee goals remain in second half of year.

More from Product Reviews

Expedited Reviews For China-Originated Drugs Shift Back Home

 
• By 

The proportion of China-originated drugs granted expedited reviews in China doubled in the first half of this year, Pharmaprojects data show, surpassing those receiving similar treatment in the US and likely driven by multiple factors.

Sarepta Will Resume US Elevidys Shipments For Ambulatory DMD Patients After FDA Reverses Course

 
• By 

The FDA recommended removal of a voluntary hold on shipments of the gene therapy to younger patients after finding that the death of an 8-year-old boy in Brazil was unrelated to Elevidys. Discussions on safety of DMD treatment for non-ambulatory patients is ongoing.

A Record Year For US FDA Approvals? Commissioner Says It’s Possible

 

FDA Commissioner Martin Makary suggested 60 new molecular entities could be approved in 2025, which appears possible, but can the strained staff deliver?