Polyrizon Ltd., a biotechnology company focusing on the development of intranasal products announced the submission of its full pre-submission (Pre-Sub) package to the U.S. Food and Drug Administration (FDA) for its PL-14 product, designed to help individuals suffering from nasal allergies. The submission includes comprehensive documentation covering manufacturing plans, clinical development strategies, and regulatory pathways. This submission represents a significant progress in Polyrizon’s regulatory strategy, paving the way for potential marketing clearance and addressing a critical unmet need in allergy treatment.

Polyrizon’s PL-14 Allergy Blocker is a novel, non-invasive nasal spray that forms a physical barrier designed to provide rapid, long-lasting relief from allergic rhinitis symptoms by blocking allergen entry. The PL-14 Allergy Blocker is intended to treat allergy sufferers by promoting the alleviation of mild allergic symptoms (i.e., mild nasal irritation including itchy, runny, or congested nasal passages) triggered by the inhalation of various airborne allergens including indoor and outdoor environmental pollens, house dust, animal hairs, and dust mites.

“We are pleased to submit this Pre-Sub to the FDA, a crucial step in our journey to bring PL-14 Allergy Blocker to market,” said Tomer Izraeli, CEO of Polyrizon. “Allergic rhinitis affects hundreds of millions of people worldwide, and we believe that our innovative approach has the potential to transform treatment options. This submission positions Polyrizon for accelerated development in this high-demand therapeutic area.”