Germany-based specialty pharmaceutical company Novaliq has enrolled the first patient in a Phase ll clinical trial of NOV03 to treat dry eye disease (DED).
The SEECASE trial is a multi-centre, randomised, double-masked, saline-controlled study examining the effect of NOV03 at two different dosing regimens on signs and symptoms of DED.
During the trial, NOV03 will be assessed in two dosing regimens, two and four instillations per day.
The trial represents Novaliq’s second late-stage clinical programme in the US, and is expected to provide top-line data by the second half of this year.
Novaliq Clinical Development vice-president Sonja Krösser said: “The initiation of this Phase ll US trial represents another significant clinical milestone that advances our clinical dry eye programme, and moves us a step closer to bringing novel dry eye treatments to market that meet unmet needs.
“Earlier studies have demonstrated a highly favourable safety and efficacy profile in patients with DED, particularly for evaporative DED and MGD.
“We are optimistic that we will see similar outcomes in the SEECASE Phase ll trial.”
Novaliq further noted that its NOV03 is specifically designed for patients with evaporative dry eye disease caused by meibomian gland dysfunction.
NOV03 is also capable of immediately stabilising the lipid layer to prevent its excessive evaporation.
With further penetration into the meibomian glands, the solution dissolves meibomian lipids and eventually helps to improve the gland functionality.