Aldeyra Therapeutics, Inc. announced the release of topline data from its 12-month safety clinical trial on 0.25% topical ocular reproxalap for the treatment of dry eye disease (DED).
Tell me about reproxalap.
The investigational new drug candidate is Aldeyra’s first-in-class, small-molecule modulator of reactive aldehyde species (RASP).
RASP is known to be elevated in ocular and systemic inflammatory disease as well as cause decreased tear production, eye redness, change in lipid tear composition, and increased ocular inflammation.
How quickly can it work?
Per study data, reproxalap illustrated signs of activity ranging from within minutes of administration to up to 12 weeks.
Didn’t I just hear news about it?
Indeed. Aldeyra announced earlier this month that the FDA accepted its new drug application (NDA) for reproxalap. A Prescription Drug User Act (PDUFA) is designated for November 23, 2023.
So it’s already been studied in clinical trials, correct?
Correct. The NDA submission was based on data on reproxalap’s performance in five adequate and well-controlled clinical trials. See here for the details.
Now talk about the latest study.
This 12-month, vehicle-controlled, multicenter, parallel-group safety trial on reproxalap enrolled 447 patients diagnosed with DED—of which 299 patients were treated with reproxalap and 148 treated with vehicle.
Assessments on visual acuity and ocular safety (consisting of intraocular pressure [IOP]; slit-lamp examination; corneal endothelial cell density; and dilated fundoscopy) were conducted at six points: baseline, 4 weeks, 6 weeks, 3 months, 6 months, and 1 year of treatment.
What was being observed?
Primary endpoints included the proportion of treatment-related ocular safety events, as indicated in the beginning of the trial, compared to patients treated with vehicle. Further, change from baseline to VA was assessed post-hoc over the course of 12 months via logMAR using a repeated measures analysis.
In both treatment groups, VA showed improvement over the 12-month period. Patients treated with reproxalap exhibited statistically superior (P = 0.018) VA improvement compared to vehicle-treated patients.
Reproxalap-treated patients’ logMAR also saw an estimated 37% improvement (P < 0.0001) from 0.13 (Snellen 20/27) to 0.08 (Snellen 20/24).
Any adverse events?
Aldeyra reported no serious adverse events (SAEs) for any patient, with ocular safety parameters being similar in both treatment groups.
Mild and transient instillation site irritation was observed as the most common AE in patients treated with reproxalap.
As Aldeyra previously announced, a Prescription Drug User Act (PDUFA) is designated for November 23, 2023.