Neuroptis, a company specialized in the development of drugs to treat eye disorders, has announced positive results from a second animal trial of its preservative-free ML7 eye drops. ML7 is intended for use in the treatment of eye surface diseases, particularly dry eye syndrome.
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.
"These results have exceeded our expectations. The return to normal of the tarsal glands shows that ML7 eye drops significantly reduce inflammation of the eye surface and its associated structures. We have submitted a patent application for this mechanism of action. ML7 eye drops help to restore a quality tear film while preventing the tears from evaporating too quickly," said Dr Eric Belot, CEO of Neuroptis.
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. Inflammation is recognized as the primary contributing factor in dry eye syndrome (source: PMID: 25390549). 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.