Ohr Pharmaceutical, at work on an eye drop to complement the blockbuster Lucentis, watched its top prospect fail to meet the main goal in a Phase II trial, dimming hopes for the drug's future.
In a 9-month trial on patients with age-related macular degeneration (AMD), Ohr ($OHRP) coupled its OHR-102 eye drops with Lucentis, testing how well the drug could reduce the need for Roche's ($RHHBY) injection compared with placebo. OHR-102 failed to meaningfully decrease the mean number of injections versus water drops, Ohr said, failing its primary endpoint and sending the biotech's shares down nearly 70% on Friday morning.
But, as ever, there's some good news, according to Ohr. The study randomized 142 patients, but looking only at the 70 with choroidal neovascularization (CNV), Ohr found that OHR-102 improved visual acuity in 42% of patients versus placebo's 28%. The result was "clinically meaningful," Ohr said, but not, apparently, statistically significant.
Still, Ohr sees a path forward with the drug, focusing on AMD patients with CNV and arguing that the subpopulation results support a Phase III effort.
"Now that the full data from the Phase II study is available, we are thoroughly evaluating all of the underlying factors that may have contributed to variability in patient response," Chief Medical Officer Dr. Jason Slakter said in a statement. "These analyses will help guide and optimize the design of the Phase III trials of OHR-102 in wet-AMD."
- read the results