RASP to be investigated as biomarker for dry eye disease
Aldeyra shared development plans to support a new drug application for reproxalap for dry eye disease.
After reaching an agreement with the FDA to explore the use of reactive aldehyde species as an objective sign for the treatment of dry eye disease, Aldeyra Therapeutics announced plans for a new drug application for reproxalap.
The FDA agreement is a meaningful announcement that allows Aldeyra to conduct the appropriate studies to evaluate the treatment effect of reproxalap in dry eye disease, Gary D. Novack, PhD, professor of ophthalmology at the School of Medicine at University of California, Davis, and president of PharmaLogic Development, told Ocular Surgery News.
No regulatory biomarkers have been used in an approval by the FDA for treatments for dry eye disease or ocular surface disease. Novack published a review article in Eye and Contact Lens in 2019, writing that an ideal biomarker for ocular surface disease would be a “simple laboratory or clinical evaluation before treatment, which would predict subsequent therapeutic response.”
“This announcement by Aldeyra shows the openness of the FDA. This particular division of ophthalmology has always been open to data, and this is yet another example of how they’re open to good science. This provides a potential meaningful way to show this is a sign directly related to the mechanism of action. It provides an opportunity for Aldeyra to complete these studies and get their data,” he said.
Two clinical trials
The company intends to initiate two clinical trials to assess reproxalap in reducing tear levels of reactive aldehyde species (RASP) in patients with dry eye disease.
Assessment of RASP is expected after single and multiple doses of the drug over 2 days in the two planned trials.
When given topically, reproxalap has demonstrated consistent significant activity in dry eye disease, allergic conjunctivitis and ocular inflammation. In a phase 2a clinical trial, reproxalap demonstrated a reduction in tear RASP levels after 28 days of treatment, according to a company press release.
Results from the first RASP trial are expected by the end of the year, and a safety trial in patients with dry eye disease is expected in the fourth quarter. The NDA submission is expected in late 2021.
“It’s very interesting and provides a great opportunity. The FDA is open to this for Aldeyra to now go out and do appropriate studies to see if they see a treatment effect with their drug,” Novack said.
- References:
- Aldeyra plans advancement of reproxalap for dry eye. www.healio.com/news/ophthalmology/20200605/aldeyra-plans-advancement-of-reproxalap-for-dry-eye. Published June 5, 2020. Accessed July 1, 2020.
- Aldeyra Therapeutics announces new drug application (NDA) development plans for dry eye disease. https://ir.aldeyra.com/news-releases/news-release-details/aldeyra-therapeutics-announces-new-drug-application-nda. Published July 7, 2020. Accessed July 8, 2020.
- Aldeyra Therapeutics reaches agreement with the US Food and Drug Administration for the use of RASP as an objective sign for the treatment of dry eye disease. ir.aldeyra.com/news-releases/news-release-details/aldeyra-therapeutics-reaches-agreement-us-food-and-drug. Published June 4, 2020. Accessed July 1, 2020.
- For more information:
- Gary D. Novack, PhD, can be reached at PharmaLogic Development, 17 Bridgegate Drive, San Rafael, CA 94903; email: gary_novack@pharmalogic.com.
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