Human clinical trials are planned for mid 2014
Neuroptis Biotech, the ophthalmology drug research and development specialist, announces 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.
The candidate molecule, ML7, is the first in a new therapeutic class. It has the potential to bring an effective, targeted therapeutic response to the millions of people who suffer from dry eye syndromes. This can affect patients' lachrymal apparatus, manifesting as insufficient quality or quantity of tears and a feeling of dry eyes.
The syndrome may be idiopathic, or it may be associated with allergies, inflammation of the anterior segment or Gougerot-Sjogren syndrome. It may also occur following cataract surgery.
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):
"The completion of preclinical work and studies marks the culmination of efforts by the team at Neuroptis Biotech and their partners, Provence Technologies, Octalia, Cerep and Iris Pharma," said Dr Eric Belot, CEO of Neuroptis Biotech. "We will start phases I and II in the next few months, as soon as the EMA has given its approval for trials on human subjects.”
Treatment for dry eye syndromes is a growth market with an estimated value of USD 1.2 billion worldwide. The company will begin production of clinical batches to launch the clinical trials through a subcontractor. They will also submit the requisite applications for approval by the European Medicines Agency (EMA) and local patient protection committees.