Avizorex Pharma submits Clinical Trial Application for its lead compound AVX-012 for Dry Eye Syndrome
Avizorex Pharma –an ophthalmology biotech company with offices at Barcelona Science Park (PCB)– announces the submission of a Clinical Trial Application (CTA) to the Spanish Competent Authority, requesting clearance to initiate a Phase I/II clinical trial investigating the use of AVX-012 Ophthalmic Solution, a small molecule with a novel mechanism of action to treat patients suffering from mild to moderate Dry Eye Syndrome (DES).
The clinic trial, a multicenter study, double-blind, placebo-controlled has been designed to confirm AVX 012 Ophthalmic Solution safety, tolerability and efficacy in DES patients, and if cleared, is expected to be initiated in late 2016 in multiple sites across Spain.
We believe AVX-012 has the potential to significantly improve both signs and symptoms in this large population of DES patients, due to its selective action on temperature/humidity detecting neurons in the cornea and thereby regulating basal tear production to stabilize tear film and might contribute some analgesic effects that reduce ocular discomfort associated with dry eye”,said Patrick Tresserras, Chief Executive Officer of Avizorex Pharma.
Dry Eye Syndrome (DES) is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolality of the tear film and inflammation of the ocular surface. Prevalence reported in the USA, Australia and Europe is approximately 5-15 %, 25% in Canada and 30-50% in Asia, with the highest prevalence being observed in subjects of Asian and Hispanic origin, and is more common in women, especially in postmenopausal women (Source: Gayton, 2009. EMA / 450332/2012, 2012).
“Treatment of dry eye is mainly symptomatic; very few pharmacological treatments for this disease are currently approved in the world. Therefore, DES therapeutics market will grow to $4.6 Billion by 2024, being one of the fastest growing indications in ophthalmology”, saidTresserras.
Avizorex Pharma is a Spanish ophthalmology biotech company founded in 2013 in Alicante (Spanish autonomous community of Valencia), with offices at Barcelona Science Park (PCB). The biotech is focused on developing novel therapies for Dry Eye Syndrome (DES) based on Prof. Carlos Belmonte’s research on the role of temperature-sensitive neurons in tear film regulation at the Instituto de Neurociencias de Alicante (IN). The findings of his studies were published in Nature Medicine in 2010 (doi:10.1038/nm.2264) and demonstrated that stimulation of a protein called TRMP8 activates cold receptors present on the surface of the eye and increases tear secretion naturally, hence reducing ocular dryness.
Avizorex closed a Series A financing round in October 2014 with Barcelona-based VC firm Inveready Technology Investment Group. Inveready has over 70 M € under management through different funds, and has invested into Avizorex through its Life Sciences specialized fund Inveready Innvierte Biotech II.