Aldeyra prepares to submit dry eye treatment to FDA
Based in Lexington, Mass. Aldeyra Therapeutics reported that his reproxalap hit the mark in the phase III Tranquility-2 study for dry eye. The drug showed statistical superiority for its two primary endpoints.
Reproxalap is a first-in-class small molecule modulator of reactive aldehyde species (RASP). RASP is elevated in ocular and systemic inflammatory diseases.
In the study, the drug was statistically superior to vehicle – which is similar to a placebo – for Schirmer’s test, and had Schirmer’s test responder proportions of 10 mm or greater after just one day of receiving the drug. . Schirmer’s test is a measure of eye tear production. For dry eye medications, this is the most common objective indication needed for drug approval.
“The Schirmer test is an accepted method for measuring tear production and has been used in clinical studies for more than 20 years,” said Dr. Cathleen McCabe, MD, dry eye specialist for The Eye Associates in Sarasota, in Florida, and Chief Medical Officer. at Eye Health America. “I am extremely encouraged by the results of the Schirmer test and the other clinical signs data produced by reproxalap, underscoring the broad therapeutic benefit that this therapy can bring to patients suffering from dry eye disease. »
The company plans to submit a New Drug Application (NDA) to the US Food and Drug Administration based on the data. If approved, it would be the first dry eye drug that treats symptoms and at least two labeled objective signs of the disease.
“Many of my dry eye patients complain that current treatments take too long to work, prolong symptoms and negatively affect quality of life,” said Dr. Jacob R. Lang, OD, FAAO, dry eye specialist. dry eye for Associated Eye Care in Saint Paul, Minnesota. “Based on its rapid symptomatic control demonstrated in multiple clinical trials, reproxalap has the potential to be not only an important treatment option, but also a first-line therapy for dry eye disease.”
Drugs approved on the market for dry eye include Tyrvaya from Oyster Point (varenicline solution), AbbVie/Allergan’s Restasis (cyclosporine ophthalmic emulsion), Cequa from Sun Ophthalmics (cyclosporine ophthalmic solution), Xiidra from Novartis (lifitegrast ophthalmic solution) and Eysuvis from Kala Pharmaceuticals (loteprednol etabonate ophthalmic suspension). ).
The dry eye market is broken by product, including artificial tears, anti-inflammatories, punctal plugs, secretagogues and others. The overall market in the United States in 2021, according to Intelligence of Mordorwas $5.209 billion.
“The positive Tranquility-2 results should complete the most comprehensive NDA submission yet for dry eye disease,” said Dr. Todd C. Brady, MD, Ph.D., President and CEO of Aldeyra. “I would like to express my sincere gratitude to the principal investigators and the more than 1,700 patients who have participated in clinical trials of reproxalap over the past five years, as well as to our shareholders and other stakeholders for their continued confidence in Aldeyra. For many of the more than 39 million American adults who suffer from dry eye disease, we believe the need for a fast-acting therapy with a new mechanism of action is important. We are confident in the potential of reproxalap to meet this need.
Aldeyra’s pipeline includes another RASP modulator, the ADX-629. In March, the company announcement the results of a trial with the drug in 10 patients with moderate psoriasis. At 12 weeks, the Psoriasis Area and Severity Index (PASI) scores showed statistically significant decreases from baseline and maximum PASI 50% and PASI 75% response percentages of 57% and 24%, respectively . They also reported data from a crossover trial of the drug in eight patients with mild asthma.
Additionally, ADX-629 is being evaluated in mild to moderate COVID-19.
At the time, Brady said, “The promising results shown by ADX-629 represent the first clinical data supporting RASP modulation as a new pharmacology for the potential treatment of systemic diseases. Accordingly, we plan to advance our proprietary RASP modulator platform, which includes ADX-629 and other novel molecules, into new RASP-mediated indications, achieving another milestone for Aldeyra as we continue to focus on systemic and retinal diseases.