Potential best in class for dry eye

Article

LX214, a topical mixed nanomicellar formulation of voclosporin, has completed its Phase 1 human safety and an open-label pilot efficacy study and is being heralded by its maker Lux Biosciences as a promising treatment for dry eye.

LX214, a topical mixed nanomicellar formulation of voclosporin, has completed its Phase 1 human safety and an open-label pilot efficacy study and is being heralded by its maker Lux Biosciences as a promising treatment for dry eye.

Randomized, double-masked, placebo-controlled data from 30 healthy volunteers showed LX214 to be well tolerated at the two doses (0.02% and 0.2%) studied, with safety and tolerability measurements (pain, burning, reddening, photophobia, foreign body sensation and others) indistinguishable from placebo.

An additional cohort of five patients with severe dry eye syndrome was treated with LX214 in both eyes twice a day for 14 days at the target 0.2% concentration. Data from these patients confirmed that systemic exposure to voclosporin was very low and below the threshold level where measurement of voclosporin blood concentrations would be required in future studies. Signs and symptoms of disease were also assessed in this cohort of patients. Despite the small sample size and short duration of treatment, clinically meaningful improvements were noted in both signs (tear production) and symptoms (OSDI index) at both 7 and 14 days.

“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,” said Eddy Anglade, MD, Lux Biosciences' Chief Medical Officer. “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.”

Related Videos
ARVO 2024: Andrew D. Pucker, OD, PhD on measuring meibomian gland morphology with increased accuracy
 Allen Ho, MD, presented a paper on the 12 month results of a mutation agnostic optogenetic programme for patients with severe vision loss from retinitis pigmentosa
Noel Brennan, MScOptom, PhD, a clinical research fellow at Johnson and Johnson
ARVO 2024: President-elect SriniVas Sadda, MD, speaks with David Hutton of Ophthalmology Times
Elias Kahan, MD, a clinical research fellow and incoming PGY1 resident at NYU
Neda Gioia, OD, sat down to discuss a poster from this year's ARVO meeting held in Seattle, Washington
Eric Donnenfeld, MD, a corneal, cataract and refractive surgeon at Ophthalmic Consultants of Connecticut, discusses his ARVO presentation with Ophthalmology Times
John D Sheppard, MD, MSc, FACs, speaks with David Hutton of Ophthalmology Times
Paul Kayne, PhD, on assessing melanocortin receptors in the ocular space
Osamah Saeedi, MD, MS, at ARVO 2024
© 2024 MJH Life Sciences

All rights reserved.