Table 3.

Clinical trial data on CLS-AX (Suprachoroidal delivery of Axitinib).

	wet AMD	wet AMD
Phase	I/IIa (OASIS) NCT04626128	OASIS Extension study NCT05131646
Geography	US	US
Status	Completed	Ongoing
No of Patients	27 (recruiting)	19 (enrolment completed)
Design	Non-randomized, Multi-centre, Open-label, Dose-escalation, Sequential Assignment	Non-interventional, Open-label, Dose-extension
Inclusion criteria	• Diagnosis of nAMD in the study eye • Active subfoveal choroidal neovascularization secondary to AMD • 2 or more prior anti-VEGF intravitreal injections • EDTRS BCVA score ≤ 75 & ≥ 20 letters	Enrolled in & completed the Parent study (OASIS), as part of cohort 2 or cohort 3, or cohort 4.
Dose & Frequency	Dosing: 0.03, 0.10, 0.50, or 1 mg of CLS-AX; Suprachoroidal injection • Cohort1: 0.03 mg (low dose) (n = 6) • Cohort 2: 0.10 mg low-mid dose (n = 5) • Cohort 3: 0.50 mg high-mid dose (n = 8) • Cohort 4: 1.0 mg high dose (n = 8)	Participants who completed cohorts 2 or 3 or 4, were followed for an additional 12 weeks exit from the parent OASIS study. • Cohort 2: 0.10 mg low-mid dose (n = 5) • Cohort 3: 0.50 mg high-mid dose (n = 8) • Cohort 4: 1.0 mg high dose (n = 8)
Primary endpoint	• Incidence of TEAEs (week 12) • Incidence of serious AEs (week 12)	• The number of subjects experiencing TEAEs (24 weeks) • The number of subjects experiencing serious AEs (24 weeks)
Secondary endpoint	• Change from baseline in pre-injection Intraocular Pressure (week 12) • Change from Baseline (Visit 2) in central subfield retinal thickness & BCVA • Incidence of subjects receiving & qualifying to receive additional IVT aflibercept injections (week 12)	• Change from baseline in pre-injection Intraocular Pressure (24 weeks) • Change from Baseline in central subfield retinal thickness & BCVA (24 weeks) • Incidence of subjects receiving additional therapy in the study eye (8 weeks)
Results Safety	• Excellent safety profile at all doses and timepoints • No Serious Adverse Events No dose limiting toxicities • No Adverse Events from inflammation
Results Durability	• In OASIS, to 3 months: ≥73% reduction in treatment burden 69% of patients did not receive additional therapy 92% of patients did not receive additional therapy as per protocol • In Extension Study, to 6 months (interim data: 77% reduction in treatment burden.
Results Biologic Effect	• Stable mean Best Corrected Visual Acuity (BCVA) • Stable mean Central Subfield Thickness (CST) • On optical coherence tomography (OCT), anatomical signs of tyrosine kinase inhibitor (TKI) biologic effect were observed in anti-VEGF treatment-experienced sub-responders

AE adverse event, anti-VEGF anti vascular endothelial growth factor, BCVA best corrected visual acuity, CST central subfield thickness, ETDRS Early treatment diabetic retinopathy study, IVT intravitreal therapy, nAMD neovascular age-related macular degeneration, NPDR Nonproliferative diabetic retinopathy, OCT optical coherence tomography, SAE serious adverse event, TEAE treatment emergent adverse event, wet-AMD wet age-related macular degeneration.