|Ohr CMO Dr. Jason Slakter|
Moving on from a painful Phase II failure for its top prospect, Ohr Pharmaceutical ($OHRP) heralded new hope for the eye drop in retinal vein occlusion thanks to some positive results from a midstage study.
In an investigator-sponsored Phase II trial, a combination of OHR-102 and Roche's ($RHHBY) Lucentis performed better than the blockbuster drug alone in patients with macular edema tied to retinal vein occlusion, Ohr said. In the 20-patient study, investigators treated all subjects with both drugs for 10 weeks before randomizing them 1:1 to either stay on the combo or switch to as-needed Lucentis alone. At 38 weeks, the patients taking OHR-102 could read an average of 4.5 more letters on an eye chart than those solely on Lucentis, a difference Ohr says is clinically significant.
The results sent the biotech's shares up as much as 57% on Monday, helping make up some of the ground Ohr lost when OHR-102 missed its goals in a Phase II age-related macular degeneration (AMD) trial disclosed in March. In that study, Ohr sought to demonstrate how well its eye drop could reduce the need for Lucentis injections, but OHR-102 failed to significantly outdo placebo. The drug did perform better among a subpopulation of AMD patients in the trial, and Ohr has said it plans to blueprint a Phase III effort to capitalize on that promise. Investors were less optimistic, however, sending the biotech's share value down more than 70%.
But in the retinal vein occlusion study, patients getting OHR-102 needed an average of two Lucentis shots between weeks 10 and 38, while those getting placebo drops needed 3.3 over the same period, Ohr said. And, at 38 weeks, 80% of volunteers getting both drugs reported a mean increase in visual acuity with no patients charting worsened vision. In the Lucentis-only arm, just 50% improved acuity.
"This trial constitutes the second clinical study in a retinal vascular disorder which has shown a positive and clinically meaningful benefit in visual acuity using OHR-102 combination therapy versus an intravitreal anti-VEGF injection alone," Ohr Chief Medical Officer Dr. Jason Slakter said in a statement. "The consistency of the efficacy data in this study, combined with the favorable safety profile of OHR-102, we believe warrants further study in a large controlled clinical trial."
- read the statement