The news of positive clinical trial results caused the price of Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) shares to rise significantly during the most recent trading session. ALDX’s share price rose 21.72%, ending the day at $5.10.
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Reproxalap Phase 3 Trial Positive Results
Aldeyra (ALDX) reported that the main objective of their experimental therapy candidate, 0.25% reproxalap ophthalmic solution, has been accomplished. In a Phase 3 randomized, double-masked, vehicle-controlled clinical study, ALDX reached the significant milestone.
This study aimed to evaluate the efficacy of reproxalap in treating the condition of dry eyes. Reproxalap demonstrated statistically significant superiority over the vehicle control in lowering ocular discomfort, which is a symptom of dry eye sickness.
This milestone is the first successful outcome from a Phase 3 clinical investigation in a dry eye chamber, with the primary goal being ocular pain. Aldeyra’s sees that These results demonstrate that reproxalap can effectively reduce the discomfort associated with dry eye disease.
The Trials and Their Prospects
The Phase 3 trial involved administering a vehicle control (a placebo without the active ingredient) to participants before and during exposure to a dry eye chamber, aligning with FDA’s draft guidance on dry eye disease.
Subsequently, 132 patients were randomized to receive either reproxalap or vehicle treatment before and during a subsequent exposure to a dry eye chamber. Out of the total, 66 patients were treated with reproxalap, while the remaining 66 received the vehicle control.
The primary endpoint assessed was ocular discomfort, measured from 80 to 100 minutes in the chamber. This trial was designed to meet the FDA’s requirements for a New Drug Application (NDA) resubmission, as specified in a prior complete response letter.
The study aimed to provide “at least one additional adequate and well-controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye.” Aldeyra indicates that reproxalap is the first investigational drug to provide pivotal data supporting both acute and chronic efficacy in reducing symptoms of dry eye disease.
The company anticipates resubmitting the NDA in 2024, with a review period expected to span six months, as per FDA guidance.
