After getting halted in Nasdaq for sometime, shares of Aldeyra Therapeutics (ALDX) resumed trading and climbed up about 60% during the pre-market trading on positive top-line results from its eye inflammation disease trial. The clinical trial met the primary endpoint and the key secondary endpoint for both concentrations of the eye drug reproxalap.
The company announced positive results from its Phase 3 ALLEVIATE Trial of reproxalap, its eye drug, in patients with allergic conjunctivitis.
In preparation for subsequent clinical testing, Aldeyra is conducting clinical method development studies to assess the feasibility of measuring ocular itching induced by environmental exposure to allergen.
Also read: Aldeyra Therapeutics (ALDX) Q4 2018 Earnings Conference Call Transcript
In the second half of 2019, Aldeyra plans to meet with regulatory authorities to discuss the ALLEVIATE results and remaining clinical requirements for a potential submission of a New Drug Application to the FDA.
CEO Todd Brady said, “Consistent with positive results from five prior Phase 2 clinical trials in ocular inflammation, today’s announcement confirms the potential of reproxalap as a novel and clinically meaningful approach for the treatment of allergic conjunctivitis. Given that approximately half of allergic conjunctivitis patients also suffer from ocular dryness, we believe the ALLEVIATE results highlight the relevance of reproxalap to our current Phase 3 program in dry eye disease.”
The company also announced that it entered into a $60 million loan and security agreement with Hercules Capital.
Aldeyra stock had declined 14% since the beginning of this year and 11% in the past 12 months.