ALG-1007 topical eye drop meets primary, secondary endpoints for dry eye disease
A fixed combination of 0.6% risuteganib (RSG) and 0.125% sodium hyaluronate in a vehicle solution (ALG-1007; Allegro Ophthalmics) demonstrated statistically significant superior improvement of signs and symptoms of dry eye disease compared to control solutions, according to study results presented by Eric D. Donnenfeld, MD, at the 2021 ASCRS Annual Meeting.
In the study, 64 total eyes were randomized to receive either vehicle (n = 16), 0.125% sodium hyaluronate (SH; n = 16), 0.6% RSG (n = 16), or 0.6% RSG + SH (n = 16), for a total of 12 weeks. Co-primary endpoints were change in nasal conjunctival staining and DEMS score and secondary endpoints were change in tear break-up time (TBUT), total ocular staining, VAS score, and inferior cornea staining.
All primary and secondary endpoints were met.
At 12 weeks, all signs and symptoms were statistically greater in the SH group and RSG group compared to the vehicle group; and the RSG group and RSG+SH group compared to the SH group. The most robust improvements were demonstrated in the RSG+SH group.
No drug-related adverse events or serious adverse events were 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. Donnenfeld, founding partner of Ophthalmic Consultants of Long Island and Clinical Professor of Ophthalmology at NYU in a press release. “The components in ALG-1007 appear to have synergistic effects. It should be emphasized that no adverse events, ocular irritation, or prolonged blurred vision were reported in the study—an impressive finding.”
It was also announced that U.S. Food and Drug Administration has accepted the filing of an Investigational New Drug (IND) application for ALG-1007.
Donnenfeld E, et al. Prospective, Randomized, Double-Masked, Vehicle-Controlled, Safety and Efficacy Study of Topical Risuteganib in Treating Dry Eye Disease. Presented at: 2021 ASCRS Annual Meeting.