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MILAN, Dec. 5, 2024 /PRNewswire/ — NTC, an international R&D focused pharmaceutical company headquartered in Italy, presents positive results from Phase II MIRAKLE study, a multicentre, randomized, blinded-assessor, phase II non-inferiority study evaluating the efficacy and tolerability of NTC014 (quinolone antibiotic + NSAID in eye drops solution) in the treatment of bacterial conjunctivitis in adults.
Despite NTC014, due to its simplified therapeutic regimen, has been administered at a lower posology than the antibiotic comparator –25% of less antibiotic administered – the main results showed the non-inferiority of NTC014 eye drops vs antibiotic alone in microbiological eradication, with unexpected efficacy results even against pathogens classified as Intermediate or Resistant to the quinolone antibiotic under study.
"These interim findings reaffirm that NTC014 is eligible to be a new treatment for bacterial conjunctivitis", Alessandro Colombo, Chief Scientific Officer, NTC, states. "We aim at demonstrating with robust clinical evidence value and potential for NTC014, considering also that this drug responds to our mission to contribute to fighting antibiotic resistance by using less antibiotics, for a shorter treatment duration with no limitation of usage, also in case of non-confirmation of bacterial etiology."
"We are encouraged by the overall results of the Mirakle study", says Riccardo Carbucicchio, Chief Executive Officer in NTC, "NTC 014 is first in class combination worldwide of an antibiotic and an NSAID. Given the significant unmet medical need, NTC014 aims to provide physicians with an effective treatment for moderate-severe bacterial conjunctivitis, a common eye infection. We believe that NTC 014 has a great potential and we aim to finalize the commercial partnering for this asset in most countries of the world before end of 2025. We do not exclude to develop this asset for surgical use too".
Conjunctivitis is a common disease in Western Countries and imposes economic and social burdens.
Viral conjunctivitis is the most common cause of infectious conjunctivitis both overall and in the adult population, bacterial conjunctivitis is the second most common cause and is responsible for the majority (50%-75%) of cases in children.
NTC has already successfully developed and launched the first combination of a quinolone and steroid for post cataract surgery1, licensed in almost 90 countries and currently marketed in 60 countries, in Europe, Asia, Americas and Africa.
About NTC
A pharmaceutical company headquartered in Milan – Italy, with distributors and partners in more than 100 countries, engaged in research, development, registration, and commercialization of drugs, medical devices, and food supplements in ophthalmology, and other therapeutic areas including pediatrics, gynecology, and gastroenterology. NTC offers more than 200 partners innovative and high quality standard pharmaceutical products. For more information, please visit www.ntcpharma.com
1. Bandello F., et al. One week of levofloxacin plus dexamethasone eye drops for cataract surgery: an innovative and rational therapeutic strategy. Eye (2020), https://doi.org/10.1038/s41433-020-0869-1
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