Allegro Ophthalmics, a privately held US biopharmaceutical company, has announced that all primary and secondary endpoints of a 64-eye vehicle-controlled study of ALG-1007 topical eye drop in patients with dry eye disease (DED) were met.

According to the study’s authors, patients treated with ALG-1007 (a fixed combination of 0.6% risuteganib and 0.125% sodium hyaluronate in a vehicle solution) experienced statistically significant improvements in tear break-up time, inferior corneal staining and scores on the dry eye management scale and visual analogue scales, compared with control, from two weeks. Used twice daily, ALG-1007 demonstrated no adverse events, ocular irritation, or prolonged blurring of vision, researchers reported.

“I’m very encouraged by the results of this trial, which demonstrated that ALG-1007 had the most robust improvement in signs and symptoms of dry eye compared to the comparator arms,” said Dr Eric Donnenfeld, professor of ophthalmology at New York University who presented the results at the 2021 American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators annual meeting in Las Vegas. “The components in ALG-1007 appear to have synergistic effects,” he added.

These results support the development of a US-based phase 2b/3 study, said Dr Vicken Karageozian, president and CEO of Allegro Ophthalmics. “This, coupled with the FDA’s acceptance of Allegro’s Investigational New Drug application, will allow investigators to collect more data to elucidate our understanding of how ALG-1007 may provide relief to patients with dry eye.”