New Dry eye treatment drug trial
This week close to 70 people needing dry eye treatment completed RegeneRx’s Phase 2 clinical trial for the product RGN-259. The results so far look promising however further quality control, data and statistical analysis needs to be undertaken. If everything goes to schedule, the results will be published October 2011.
The clinical trial was placebo-controlled (and double-masked) and it assessed the assurance and desired effect of the RGN-259 eyedrops, which are preservative free. Patients received the treatment (or placebo) two times a day for thirty days. Different levels of classic dry eye symptoms such as dryness, surface damage, burning, grittiness, redness and ocular itchiness were monitored during the trial.
Dry eye treatment breakthrough
J.J. Finkelstein, the CEO of RegeneRx is very confident this will be a breakthrough product for his company and people needing dry eye relief. He also noted that dry eye is a very common ailment and most products on the market are not meeting consumer expectation.
In two animal models RGN-259 reduced defects of the ocular surface area caused by dry eye syndrome compared with positive and negative controls. RGN-259 even outperformed Restasis™’s ability to reduce ocular surface damage. This is remarkable as Restasis is the only approved drug for dry eye treatment.Overall, the clinical improvements with RGN-259 statistically produced exciting results for the hundreds of thousands of people desperately needing reliable dry eye relief.
It has been published that RGN-259 can adequately repair ocular surface issues, caused as a result of dry eye syndrome. A very encouraging result of the trial was a patient who had a non-healing corneal wound 23 days after surgery, and after 11 days of treatment with RGN-259 was healed. Moreover, for six patients with corneal defects, which had been existent for six weeks, after RGN-259 treatment – all had either completely recovered or showed major improvements within the treatment period. Due to the potential RGN-259 has shown a phase three study to continue research in dry eye treatment in 2012 is very likely.
