Phase III clinical trial for treatment of dry eye syndrome

A joint venture between two pharmaceutical companies looks to initiate a Phase III study for the treatment of dry eye syndrome.

ReGenTree, a collaboration between RegeneRx and GtreeBNT, announced the venture due to study the drug RGN-259. The trial, ARISE-3 is a randomised, double-masked, placebo controlled Phase III clinical trial which is entirely based on the results of ARISE-1 and ARISE-2. 

“A total of 700 patients will be enrolled into the trial and the Company expects the treatment will be completed in the first half of 2020,” officials at the company stated.

The purpose of the collaboration between the two companies is solely for the development of the drug RGN-259, in both the US and in Canada for ophthalmic indications. In addition to dry eye syndrome, the company is currently also conducting investigations into its use for those affected  by neurotrophic keratopathy (NK), an orphan indication in ophthalmology.

Dry eye syndrome is caused by a chronic lack of sufficient lubrication and moisture on the surface of the eye. Consequences of the disease are usually identified as subtle, but constant eye irritation, and could increase to significant inflammation, and possibly even scarring on the surface of the eye.

Other conditions associated with dry eye syndrome are keratitis sicca, keratoconjunctivitis sicca and dysfunctional tear syndrome. Keratitis sicca is sued to describe the dryness and inflammation of the cornea, keratoconjunctivitis sicca describes dry eye that affects both the cornea and the conjunctiva, and dysfunctional tear syndrome describes the inadequate quality of tears that could be as important as having an inadequate quantity of tears.

A huge number of people suffer from dry eye syndrome, with reports suggesting that this number will only increase. 

The novel therapeutic peptide developed by the company aims to help those with dry eye syndrome, and is a sterile, preservative-free eye drop formulation that has the compound thymosin beta 4 as its active ingredient.