Shots:

• The P-III (ESSENCE-2) trial evaluates the efficacy, safety, and tolerability of CyclASol vs vehicle in 834 subjects with DED
• The results showed a superior effect over a vehicle on the 1EPs, improvement of tCFS @29Day, (71.6%) patients responded within 4wks., improvements in a variety of symptoms compared to non-responders @29Day. The prespecified objective showed improvements and statistical significance over vehicles with an early onset of action @2wks. of dosing, results are consistent with data from earlier studies
• The company plans to submit an NDA with the US FDA in the near future & plans to work with the EMA & other regulatory to initiate the regulatory approval outside the US

Ref: PR Newswire | Image: Novaliq