Key Takeaways
- Aldeyra Therapeutics has resubmitted its New Drug Application for reproxalap to the FDA, seeking approval for its use in treating the signs and symptoms of dry eye disease, following successful clinical trials.
- In a Phase 3 trial, reproxalap significantly reduced ocular discomfort, a key symptom of dry eye disease, marking the first successful Phase 3 trial in a dry eye chamber using symptoms as the primary endpoint.
- If approved, reproxalap could become the first dry eye therapy for chronic use, showing rapid and effective symptom relief for both ocular discomfort and redness, addressing a critical unmet need for patients.
Aldeyra Therapeutics, a biotechnology company focused on discovering and developing innovative therapies for immune-mediated and metabolic diseases, has announced the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for reproxalap, an investigational topical ocular drug designed to treat the signs and symptoms of dry eye disease. The resubmission comes after a recent FDA request for additional trial data and includes positive results from a newly completed clinical trial that evaluated the drug’s effectiveness in reducing symptoms of dry eye disease.
The resubmitted NDA features a draft label that reflects reproxalap’s demonstrated acute and chronic activity. The drug has shown rapid efficacy in reducing dry eye symptoms in both a controlled dry eye chamber trial and a real-world field trial, as well as reducing ocular redness in two separate dry eye chamber trials. This comprehensive data package underscores reproxalap’s potential to offer relief to millions of people suffering from dry eye disease.
Reproxalap Poised to Become First Chronic Dry Eye Disease Therapy with Proven Rapid Symptom Relief
If approved, reproxalap would become the first dry eye disease therapy specifically indicated for chronic use that also demonstrates rapid effectiveness in alleviating key symptoms such as ocular discomfort and redness—two of the most prominent and troublesome aspects of the condition. According to Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra Therapeutics, “If approved, reproxalap would have the potential to be the first dry eye disease therapy for chronic use with pivotal data demonstrating acute activity in reducing dry eye symptoms and ocular redness, two characteristics of dry eye disease of primary importance to patients.”
Aldeyra’s recent Phase 3 randomized, double-masked, vehicle-controlled dry eye chamber trial achieved the primary endpoint, with reproxalap significantly reducing ocular discomfort compared to placebo (P=0.004). Ocular discomfort is an FDA-accepted symptom of dry eye disease, and the trial’s results highlight reproxalap’s ability to provide rapid clinical effects. To Aldeyra’s knowledge, this represents the first successful Phase 3 clinical trial in a dry eye chamber with a symptom as the primary endpoint—an achievement that demonstrates reproxalap’s potential to make a meaningful impact on patients’ quality of life.
Aldeyra Resubmits Reproxalap NDA, Aiming to Provide New Therapeutic Option for Dry Eye Disease
With this resubmission, Aldeyra is hopeful that reproxalap could soon offer a new therapeutic option for the millions of people suffering from dry eye disease. The resubmission follows the FDA’s previous review of reproxalap, during which additional clinical data was requested. Aldeyra’s new submission aims to address those requirements with further supporting evidence of the drug’s efficacy.
Under the Prescription Drug User Fee Act (PDUFA), the FDA will review the resubmitted NDA for reproxalap. The FDA is expected to acknowledge acceptance of the NDA for review within 30 days of submission and complete its review within six months, per PDUFA guidelines. If approved, reproxalap could provide patients with a novel treatment that not only targets the chronic nature of dry eye disease but also delivers rapid symptom relief in both controlled environments and real-world settings.
Aldeyra remains committed to advancing reproxalap as a transformative treatment for dry eye disease. As the company awaits the FDA’s decision, these promising clinical results reinforce the potential for reproxalap to become an important therapeutic option for the millions of patients affected by this widespread and often debilitating condition.
Resource: Aldeyra Therapeutics, October 03, 2024
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