Ocugen has commenced a Phase lll clinical trial to evaluate OCU310 for the treatment of patients with dry eye disease (DED).
The placebo-controlled trial aims to enrol around 240 patients and is expected to analyse the efficacy and safety results after 28 days of treatment.
The trial’s primary endpoints are change from baseline to four weeks or on Day 28 in Symptom Assessment iN Dry Eye (SANDE) score and the change from baseline to four weeks or at Day 28 as measured by lissamine green conjunctival staining scores.
Top-line data from the trial is expected to be released in the second half of next year.
Ocugen chairman, CEO and co-founder Shankar Musunuri said: “OCU310 has the potential to improve the signs and symptoms in patients with DED as early as 28 days as opposed to existing therapies.”
OCU310, Ocugen’ second lead product candidate, is a twice-daily, steroid-free, preservative-free eye drop of 0.2% brimonidine tartrate developed using the company’s nanoemulsion technology, OcuNanoE.
It is currently being developed for treating the signs and symptoms of DED, a common ocular disorder involving the abnormal production, composition and instability of tear film.
Earlier this year, Ocugen concluded a Phase ll clinical trial of OCU310 in patients with DED.
In the placebo-controlled proof-of-concept trial, the patients were dosed with brimonidine tartrate (0.2%) twice a day for 84 days.
The trial met its endpoint of tolerability, as well as various other pre-defined exploratory endpoints for common signs and symptoms of DED, thereby supporting the range of endpoints for the Phase lll trial.