Reproxalap

The FDA has accepted the resubmitted new drug application for reproxalap, an investigational treatment for dry eye disease, and assigned a Prescription Drug User Fee Act date, according to a press release from Aldeyra Therapeutics.

Aldeyra Therapeutics has resubmitted a new drug application for topical reproxalap for the treatment of signs and symptoms of dry eye disease, the company announced in a press release.

Patients with dry eye disease experienced improvements in ocular discomfort after treatment with reproxalap, according to a press release from Aldeyra Therapeutics.

Aldeyra Therapeutics has enrolled the first patient in a phase 3 clinical trial designed to allow possible resubmission of the new drug application of topical 0.25% reproxalap for dry eye disease, according to a company press release.

Nearly 5 months after the FDA did not approve reproxalap for dry eye, Aldeyra Therapeutics has announced a plan to resubmit a new drug application for the reactive aldehyde species modulator, according to a press release.

The FDA issued a complete response letter regarding the new drug application for reproxalap for the treatment of dry eye disease, according to a press release from Aldeyra Therapeutics.

Aldeyra Therapeutics has entered into an exclusive option agreement with AbbVie for license to develop, manufacture and commercialize reproxalap, the company announced in a press release.

Healio spoke with I. Paul Singh, MD, about recent new treatment options in dry eye.

Reproxalap, under investigation for the treatment of dry eye disease, met the primary endpoint in the phase 3 TRANQUILITY-2 trial, Aldeyra Therapeutics announced in a press release.

Reproxalap did not meet the primary endpoint of ocular redness but achieved statistical significance in the secondary endpoint of Schirmer test in a phase 3 clinical trial, according to a press release from Aldeyra Therapeutics.