Clearside Biomedical ( NASDAQ: CLSD ) reported data from a phase 1/2a trial called OASIS of CLS-AX (axitinib injectable suspension) in patients with neovascular age-related macular degeneration (wet AMD), a type of eye disease.
The trial results include final 3-month data from all 4 groups (n=27) and interim data from the Extension Study that follows participating patients for 6 months after a single dose of CLS-AX — which is administered by suprachoroidal injection via Clearside's SCS Microinjector.
The company said that CLS-AX met the trial's main goal, showing a positive safety profile at all doses and timepoints.
There were no serious adverse events and no adverse events related to inflammation, vasculitis or vascular occlusion.
There were no vitreous 'floaters' or dispersion of CLS-AX into the vitreous, no retinal detachments or endophthalmitis (pus containing inflammation of the intraocular fluids), and no adverse events related to intraocular pressure, according to the company.
In the OASIS study up to the 3-month timepoint, in groups 3 & 4 (n=16): 69% of patients did not receive additional therapy; 92% of patients did not receive additional therapy per protocol criteria. There was a 73% reduction in treatment burden from the average monthly injections in the three months before CLS-AX was given, the company added.
In the ongoing Extension Study (n=12): Supplemental anti-VEGF injection-free rate up to each visit — to month 5: 7 out of 8 patients did not receive additional therapy; to month 6: 3 out of 4 patients did not receive additional therapy, according to the company.
There was 90% reduction in treatment burden from the average monthly injections in the six months before CLS-AX was given.
Clearside noted that in the OASIS and Extension studies, CLS-AX showed signs of biologic effect with stable mean Best Corrected Visual Acuity and and stable mean Central Subfield Thickness.
"The positive safety results seen in all four cohorts, combined with evidence that CLS-AX showed biologic effect in a difficult to treat patient population, supports our belief that CLS-AX has the potential to treat retinal diseases with a repeatable, reliable, and validated in-office delivery approach using our SCS Microinjector," said Thomas Ciulla, chief medical officer and chief development officer.
The company expects to start a phase 2 trial in Q1 2023.
CLSD +3.57% to $1.45 premarket Nov. 9
For further details see:
Clearside stock rises as CLS-AX shows promise in early-stage study in eye disorder