Ocuphire reports good news trials of eye drug candidate

FARMINGTON HILLS—Ocuphire Pharma Inc., a startup pharmaceutical company focused on the development and commercialization of therapies to treat patients with a variety of ophthalmic disorders, announced statistically significant and clinically meaningful results from its recently completed two Phase 2b studies of its lead drug candidate, Nyxol Eye Drops.

Top-line results of the primary and secondary endpoints of the studies provided confirmatory and novel data on a single dose and a once-daily, evening dosing regimen for Nyxol’s pupil modulation effects. Results included a clear improvement in visual acuity, and Nyxol was affirmed to have an attractive safety and tolerability profile in both acute and chronic settings.

Based on these data, combined with data from five prior trials, Ocuphire is prioritizing its clinical program to develop Nyxol in three important indications with currently unmet or poorly addressed needs: moderate-to-severe night vision disturbances (NVD), reversal of mydriasis (RM) and presbyopia. During the first half of 2020, Ocuphire plans to initiate two Phase 3 registration studies with Nyxol in NVD and RM, and a Phase 2 study to assess the combination of Nyxol plus a miotic agent in presbyopia.

Ocuphire said its employees and clinical advisors will continue to evaluate the datasets as they prepare for the End of Phase 2 meeting with the FDA for the overall Nyxol program. Full results from these studies will be submitted for presentation at upcoming medical meetings.

“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, chair, president, and CEO of Ocuphire. “Additionally, reversing pupil dilation following the tens of millions of eye exams in doctor’s offices represents a unique single-dose treatment opportunity with a simpler and faster regulatory path to approval given its an acute versus chronic indication.”

Based on findings from the two studies, Ocuphire has bolstered its intellectual property portfolio with the filing of two more patent applications relating to Nyxol as a single agent or in combination with other approved ophthalmic agents in the treatment of presbyopia, reversal of mydriasis and glaucoma. All of the global intellectual property covering Nyxol is wholly owned by Ocuphire.

Nyxol is a novel eye drop drug candidate for multiple front-of-the-eye disorders, including night vision disturbances (NVD), reversal of mydriasis (RM), presbyopia, and normal-tension glaucoma. With safety and efficacy data from seven Phase 1 and Phase 2 trials, Nyxol has demonstrated a differentiated target product profile that includes moderately reducing pupil size (which leads to improved vision night and day at both far and near distances), lowering intraocular pressure in normal range, and convenient once-daily evening dosing with durable effects. Nyxol was originally invented by Dr. Gerald Horn, an ophthalmologist and laser vision specialist in Chicago, who also invented the recently-approved redness reliever eye drop Lumify.

NVD causes people to experience glare, halos, starbursts, and poor vision in dim light. NVD is a significant unmet need, as it affects more than an estimated 4 million people in the U.S., and there is no approved drug therapy.

Medically-induced mydriasis, or dilation, occurs as part of more than 80 million eye exams conducted in the U.S. every year, as well as millions of specialty exams. Mydriasis increases light sensitivity and impairs vision for hours, and there is currently no treatment available on the market.

{resbyopia is the progressive loss of the eye’s ability to focus on near objects, and it affects everyone to some degree with aging (over 100 million people in the U.S.), generally beginning at around age 40. There is no cure for the condition, which is generally treated with corrective lenses, however the approach of using pupil modulation is being investigated in clinical trials.

For more information, visit www.ocuphire.com.

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