Lux Biosciences reports positive results from phase 1 trial of dry eye treatment

JERSEY CITY, N.J. — Lux Biosciences announced positive results from its pilot phase 1 safety and efficacy study of LX214, a topical ophthalmic solution containing voclosporin for treating dry eye dry, according to a press release from the company.

The randomized, double-masked, placebo-controlled trial found LX214 to be well-tolerated at both 0.02% and 0.2% dose concentrations among 30 healthy volunteers. In addition, the compound yielded safety and tolerability scores similar to placebo, the release said.

Among an additional cohort of five severe dry eye patients who received a 0.2% dose concentration of LX214 in both eyes twice daily for 14 days, improvements were observed in both signs and symptoms of disease at day 7 and day 14, indicating that the compound may be a candidate for further clinical development in dry eye. In addition, systemic exposure to voclosporin was low and below the threshold level where measurement of voclosporin blood concentrations would be required in future studies, according to the release.

"The benign safety and tolerability results in humans demonstrated in both these trials confirm the positive profile exhibited by LX214 in preclinical studies, which showed this drug candidate to establish therapeutic levels in relevant ocular tissues and to be non-irritating when applied topically to the eye," Eddy Anglade, MD, chief medical officer for Lux Biosciences, said in the release. "Moreover, even though the 14 day results in severe dry eye patients were based on a small, uncontrolled sample, they presented quite encouraging indicators of efficacy."