Eye disease specialist Ocugen remains on course to have two drugs in late-stage testing before the end of the year as its dry eye disease candidate OCU310 clears a phase 2 trial.
The proof-of-concept study showed that OCU310—a combination of already-approved drugs brimonidine tartrate and loteprednol etabonate in a new nanoemulsion formulation—improved various symptoms of dry eye disease compared to placebo over 12 weeks and hit its primary target of tolerability, according to the Pennsylvania biotech.
The trial wasn’t powered to show efficacy but showed patients taking the twice-daily eyedrop formulation reported improvements in the frequency and severity of eye dryness and irritation using a questionnaire (the SANDE scale) compared to placebo.
If phase 3 trials are positive, OCU310 could provide Ocugen with a rapid route to a commercial product, as it is based on two established drugs with a long history of ophthalmic use. That “significantly derisks OCU310 from a product safety and regulatory … standpoint,” the company said in a release.
It’s estimated that as many as 16 million Americans have been diagnosed with dry eye disease, an itchy, uncomfortable and disruptive condition that is the top reason people visit their ophthalmologist. For years, the only treatment options were artificial tears, providing temporary relief at best.
There are however two approved drugs for dry eye disease—Allergan’s Restasis (cyclosporine) and Shire’s recently approved LFA-1 antagonist Xiidra (lifitegrast)—although additional treatment options are needed. Ocugen reckons its candidate will have a more rapid onset of action, improved tolerability, and a greater impact on symptoms than currently marketed rivals.
“We believe OCU310 can provide significant benefit to those suffering from dry eye disease, and we look forward to presenting the full results at a future academic meeting, and discussing with the FDA in the coming months,” commented Daniel Jorgensen, M.D., Ocugen’s chief medical officer.
The positive trial means that OCU310 could join the biotech’s brimonidine-only nanoemulsion OCU300 for ocular graft-versus-host disease in phase 3 before the end of 2018. Ocugen has previously indicated it intends to start the pivotal OCU310 program in the first half of this year.
Eyecare market research firm Market Scope estimated in January that new drugs will help drive the dry eye treatment market from a value of $3.7 billion in 2017 to nearly $4.9 billion in 2022, thanks to a series of new product introductions including Allergan’s TrueTear device for increasing tear production.