Ocuphire advances Nyxol to address varied ocular indications

Ocuphire Pharma Inc. will prioritize the development of Nyxol eye drops for three indications following positive topline results from two phase 2 studies, the company announced.

Indications are moderate-to-severe night vision disturbance (NVD), reversal of mydriasis and presbyopia, according to a company press release.

In the multi-center, randomized, double-masked, placebo-controlled MIRA-1 study, phentolamine mesylate ophthalmic solution 1% (Nyxol) reduced pharmacologically induced mydriasis 2 hours after treatment and reduced pupil diameter sooner than placebo.

In the ORION-1 multicenter, randomized, double-masked, placebo-controlled, multiple-dose study, Nyxol was evaluated in 39 subjects with elevated intraocular pressure. After 14 days of once-daily dosing, change in mean diurnal IOP from baseline, which was the trial’s primary endpoint, was not statistically significant. However, there was a trend toward greater IOP lowering in patients with lower pressure at baseline.

“We are excited to see Nyxol advance to phase 3, particularly in NVD, which was the original inspiration for the drug and includes millions of individuals with no treatment options today,” said Mina Sooch, Ocuphire chair, president and CEO. “Additionally, reversing pupil diameter following the tens of millions of eye exams in doctors’ offices represents a unique single-dose treatment opportunity with a simpler and faster regulatory path to approval given it’s an acute vs. chronic indication.”

Ocuphire Pharma Inc. will prioritize the development of Nyxol eye drops for three indications following positive topline results from two phase 2 studies, the company announced.

Indications are moderate-to-severe night vision disturbance (NVD), reversal of mydriasis and presbyopia, according to a company press release.

In the multi-center, randomized, double-masked, placebo-controlled MIRA-1 study, phentolamine mesylate ophthalmic solution 1% (Nyxol) reduced pharmacologically induced mydriasis 2 hours after treatment and reduced pupil diameter sooner than placebo.

In the ORION-1 multicenter, randomized, double-masked, placebo-controlled, multiple-dose study, Nyxol was evaluated in 39 subjects with elevated intraocular pressure. After 14 days of once-daily dosing, change in mean diurnal IOP from baseline, which was the trial’s primary endpoint, was not statistically significant. However, there was a trend toward greater IOP lowering in patients with lower pressure at baseline.

“We are excited to see Nyxol advance to phase 3, particularly in NVD, which was the original inspiration for the drug and includes millions of individuals with no treatment options today,” said Mina Sooch, Ocuphire chair, president and CEO. “Additionally, reversing pupil diameter following the tens of millions of eye exams in doctors’ offices represents a unique single-dose treatment opportunity with a simpler and faster regulatory path to approval given it’s an acute vs. chronic indication.”