Aldeyra Therapeutics, headquartered in Lexington, Mass., announced positive results from its Phase III ALLEVIATE trial of reproxalap for allergic conjunctivitis.
Aldeyra Therapeutics, headquartered in Lexington, Mass., announced positive results from its Phase III ALLEVIATE trial of reproxalap for allergic conjunctivitis.
The trial evaluated reproxalap topical ophthalmic solution in two different concentrations, 0.25% and 0.5%. The trial met the primary endpoint, which was the evaluation of ocular itch score (0 to 4) area under the curve from 10 to 60 minutes after the allergen challenge. In other words, the primary endpoint was less itchy eyes. It also met the key secondary endpoint, a two-point responder rate, which is a measure of clinical relevance.
The trial evaluated 318 patients, about 100 per arm of the trial.
“We are thrilled to announce positive results from ALLEVIATE, our first completed Phase III clinical trial,” stated Todd C. Brady, president and chief executive officer of Aldeyra. “Consistent with positive results from five prior Phase II 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 III program in dry eye disease.”
In total, the eye drug has been administered to over 700 patients across seven completed clinical trials. No safety or tolerability problems have been observed and the only adverse events have been mild and transient instillation site irritation.
The company indicates that it plans to meet with the U.S. Food and Drug Administration (FDA) in the second half of the year to discuss the ALLEVIATE results and any remaining clinical requirements for a New Drug Application (NDA) submission. The company is planning additional clinical testing, and to prepare for it, is conducting clinical method development studies, primarily to determine the feasibility of measuring ocular itching caused by environmental exposure to allergens.
Aldeyra also announced they had entered into a Loan and Security Agreement with Hercules Capital to gain access to up to $60 million in non-dilutive financing.
Allergic conjunctivitis is inflammation of the conjunctiva in the eye caused by an allergic reaction. Common symptoms are redness, itching, swelling, tearing and stringy discharge.
On January 29, the company acquired Helio Vision, a privately held biotech company. Along with Helio, Aldeyra picked up a Phase III-ready product candidate, ADX-2191, intravitreal methotrexate) to treat proliferative vitreoretinopathy (PVR). PVR is a serious vision-threatening condition with no approved treatment. It has received Orphan Drug Designation from the FDA.
PVR is also an inflammatory condition and affects up to 10 percent of patients having surgery for retinal detachment, and 50 percent or more of patients undergoing retina surgery after open globe injury. ADX-2191 was discovered by Dean Eliott, the Stelios Evangelos Gragoudas Associate Professor of Ophthalmology at Harvard Medical School and the Director of the Retina Service at Massachusetts Eye and Ear Infirmary (MEEI). It was co-developed by Eliott and Tomasz Stryjewski, a retinal surgeon at MEEI.
Under the terms of that deal, Aldeyra paid $10 million in common stock upfront, subject to a six-month lockup period, and another $2.5 million in common stock two years from the date of closing. Helio Vision shareholders are eligible for another $12.5 million in Aldeyra stock based on various regulatory milestones.
