Aldeyra intends to discontinue its noninfectious anterior uveitis program after no primary or secondary endpoints were achieved in the SOLACE trial.
According to a company press release, results of the phase 3 clinical trial of topical ocular reproxalap for noninfectious anterior uveitis demonstrated no statistically significant difference in resolution rates between patients treated with the study drug and those in the vehicle-control group
“Due to high rates of disease resolution in vehicle-treated patients, no primary or secondary endpoints were achieved in the SOLACE trial,” Todd C. Brady, MD, PhD, president and chief executive officer of Aldeyra, said in a conference call. “However, we were encouraged to see consistent signals of drug activity in all time-to-event primary and secondary endpoints. The immune-modulating activity of drug was numerically greater than that of vehicle.”
The discontinuation has no impact on the financial guidance of Aldeyra, he said, with current cash being sufficient to support Aldeyra’s four phase 3 programs in dry eye disease, allergic conjunctivitis, proliferative vitreoretinopathy and Sjögren-Larsson syndrome through 2020.
The SOLACE trial evaluated the efficacy of reproxalap ophthalmic solution (0.5%) on anterior chamber cell count (time to cure) compared with vehicle in patients with noninfectious anterior uveitis. Sixty-one patients were treated with reproxalap and 62 were treated with a vehicle.
An anterior cell grade of zero was achieved after 15 days of treatment with reproxalap compared with 21 days of treatment for vehicle. The difference was not statistically significant.
In patients with moderate disease, a prespecified subgroup, time to cure was 15 days compared with 31 days for vehicle patients, which was statistically significant (P = .05).
“Given the potential impact on standard practice in treating noninfectious anterior uveitis, we intend to publish the results of the SOLACE trial, and we hope that given the high rates of resolution for vehicle-controlled patients, the trial will be useful in the establishment of future guidelines for the treatment of the disease,” Brady said. – by Robert Linnehan