Date: 2015-01-21
Type of information: Results
phase: preclinical
Announcement: results
Company: Neuroptis Biotech (France)
Product: ML7
Action
mechanism: ML7 is a candidate molecule for the treatment of dry eye syndromes. The first in a new class of therapies, the drug may offer a targeted, effective therapeutic response for millions of people suffering from dry eye syndromes, allergy-driven inflammation, anterior uveitis or Gougerot-Sjögren syndrome. ML7 has been used in the form of preservative-free, stable eye drops, meeting the requirements of the EMEA and FDA registration agencies. Neuroptis has been granted a patent that covers the synthesis and formulation of ML7.
Disease: eye surface diseases, particularly dry eye
Therapeutic area: Ophtalmological diseases
Country:
Trial details:
Latest
news: * On January 21, 2015, Neuroptis, a company specialized in the development of drugs to treat eye disorders, announced positive results from a second animal trial of its preservative-free ML7 eye drops. Both animal trials demonstrated excellent local tolerance and very low systemic absorption. In the first trial conducted in rats by Iris Pharma, following seven days of treatment the ML7 eye drops were statistically more effective than the placebo. The second trial, conducted with the Charles River CRO in Boston, MA, involved rabbits showing significant inflammation of the cornea. In the group treated with ML7 eye drops, the tarsal (or meibomian) glands were seen to return to normal, with no further inflammation or dilation and a protective effect was observed. This is the first time that such results have been seen. To launch the clinical trials the company will begin production of clinical batches through a subcontractor and will submit applications for approval by the European Medicines Agency (EMA) and local patient protection committees. The results for the tarsal (or meibomian) glands will be published in the medical journal IOVS (Investigative Ophthalmology and Visual Science) in 2015. * On November 12, 2013, Neuroptis Biotech has announced positive results in preclinical trials of the eye-drop formulation of its ML7 product. ML7 is intended for use in the treatment of eye surface diseases, particularly dry eye. Studies in animals have shown excellent local tolerance of the product, very low systemic absorption (less than one per cent) and superior efficacy to the placebo, which uses the same eye drops, but without the ML7. In the preclinical trials ML7 was used in the form of preservative-free, stable eye drops in single-unit doses. The preclinical results were published in the medical journal IOVS (Investigative Ophthalmology and Visual Science): "Ocular Inflammation and Corneal Permeability Alteration by Benzalkonium Chloride in Rats: A Protective Effect of a Myosin light chain kinase Inhibitor" (http://www.iovs.org/content/early/2013/03/20/iovs.12-10193.abstract?papetoc) Neuroptis intends to start phases I and II in the next few months, as soon as the EMA has given its approval.
