Reproxalap demonstrates positive phase 3 results for dry eye

Topical ocular reproxalap improved ocular dryness more than vehicle in the first part of a phase 3 trial, Aldeyra Therapeutics announced in a press release.

The ongoing, adaptive, two-part, multicenter, randomized, vehicle-controlled, double-masked, parallel-group phase 3 RENEW trial compared 0.25% topical ocular reproxalap, a novel, small-molecule immune-modulating covalent inhibitor of reactive aldehyde species, and vehicle in patients with moderate to severe dry eye disease.

The study’s first part, which included 422 subjects, aimed to confirm dosing regimen, endpoints and sample size for its second part.

Patients in the constant dosing group received either four-times-daily reproxalap or vehicle for 12 weeks, while those in the induction-maintenance dosing group received four-times-daily reproxalap or vehicle for 4 weeks followed by twice-daily reproxalap or vehicle for 8 weeks.

The induction-maintenance dosing group experienced greater activity vs. vehicle than the constant dosing group and therefore will advance to the second part of the RENEW trial, which is expected to start in the first half of 2020, the release said.

“The rapid amelioration of symptoms followed by symptomatic control in the induction-maintenance dosing regimen supports the potential of reproxalap to treat a wide range of dry eye disease states, from severe flares to persistent symptoms,” David Clark, MD, chief medical officer of Aldeyra, said in the release. “In addition, consistent with our positive phase 3 results in allergic conjunctivitis, reproxalap is one of the first dry eye disease drugs to demonstrate activity in reducing ocular itching, a prominent symptom associated with dry eye disease exacerbation, which is especially common during allergy seasons.”

Reproxalap was also statistically superior to vehicle in visual analog scale ocular endpoints for itching, foreign body sensation, discomfort, photophobia and pain.

Topical ocular reproxalap improved ocular dryness more than vehicle in the first part of a phase 3 trial, Aldeyra Therapeutics announced in a press release.

The ongoing, adaptive, two-part, multicenter, randomized, vehicle-controlled, double-masked, parallel-group phase 3 RENEW trial compared 0.25% topical ocular reproxalap, a novel, small-molecule immune-modulating covalent inhibitor of reactive aldehyde species, and vehicle in patients with moderate to severe dry eye disease.

The study’s first part, which included 422 subjects, aimed to confirm dosing regimen, endpoints and sample size for its second part.

Patients in the constant dosing group received either four-times-daily reproxalap or vehicle for 12 weeks, while those in the induction-maintenance dosing group received four-times-daily reproxalap or vehicle for 4 weeks followed by twice-daily reproxalap or vehicle for 8 weeks.

The induction-maintenance dosing group experienced greater activity vs. vehicle than the constant dosing group and therefore will advance to the second part of the RENEW trial, which is expected to start in the first half of 2020, the release said.

“The rapid amelioration of symptoms followed by symptomatic control in the induction-maintenance dosing regimen supports the potential of reproxalap to treat a wide range of dry eye disease states, from severe flares to persistent symptoms,” David Clark, MD, chief medical officer of Aldeyra, said in the release. “In addition, consistent with our positive phase 3 results in allergic conjunctivitis, reproxalap is one of the first dry eye disease drugs to demonstrate activity in reducing ocular itching, a prominent symptom associated with dry eye disease exacerbation, which is especially common during allergy seasons.”

Reproxalap was also statistically superior to vehicle in visual analog scale ocular endpoints for itching, foreign body sensation, discomfort, photophobia and pain.