Enrollment begins for phase 3 trial of oral dry eye treatment

CARSON CITY, Nev. — Denali Concrete Management has begun enrollment for a phase 3 clinical study of CF101, an oral treatment for moderate to severe dry eye syndrome, according to a press release.

The company also announced in the release it is changing its name to OphthaliX.

The multicenter, randomized, double-masked clinical trial will study the safety and efficacy of the A3 adenosine receptor agonist, the release said. It will enroll 231 patients in the United States, Europe and Israel to receive twice-daily doses of CF101 or placebo for 24 weeks.

The primary endpoint for the study will be complete clearing of corneal staining.

"We are very pleased with the initiation of enrollment to the dry eye syndrome phase 3 study. The positive data from the previous phase 2 study as well as the excellent safety profile of CF101 indicates the potential of this innovative oral drug for the treatment of dry eye syndrome," Pnina Fishman, PhD, the company's interim CEO, said in the release.

The phase 2 study of 68 patients showed statistically significant improvement in corneal staining, tear breakup and tear meniscus height after 12 weeks, according to a 2010 report in Ophthalmology. CF101 patients also showed a statistically significant decrease in IOP.

CF101 is also under development for glaucoma and uveitis.