Clearside Biomedical Highlights Excellent Safety Profile of CLS-AX and Potential for Extended Duration of Effect in Data Presentation at the American Society of Retina Specialists 41st Annual Scientific Meeting - Seite 2

OASIS was an open-label, single dose-escalation Phase 1/2a trial in neovascular age-related macular degeneration (wet AMD). OASIS was a 3-month trial, followed by a 3-month Extension Study. The trial included four cohorts at the following doses: Cohort 1 at 0.03 mg; Cohort 2 at 0.1 mg; Cohort 3 at 0.5 mg; Cohort 4 at 1.0 mg. Participants from Cohorts 2, 3 and 4 who rolled over into the Extension Study were followed for a total of 6 months after a single dose of CLS-AX. Participants enrolled in OASIS were heavily anti-VEGF treatment experienced with active disease at screening, which was confirmed by an independent reading center.

Clearside’s suprachoroidal delivery platform is also featured at ASRS in presentations related to several partner programs:

• Suprachoroidal Delivery of RGX-314 for Neovascular AMD: Results of the Phase II AAVIATE Study
• Suprachoroidal Delivery of RGX-314 Gene Therapy for Diabetic Retinopathy: The Phase II ALTITUDE Study
• Phase 2 Trial of Belzupacap Sarotalocan (Bel-Sar, AU-011), a Targeted Therapy for Choroidal Melanoma via Suprachoroidal Administration
  

About CLS-AX (axitinib injectable suspension)

CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal injection. Axitinib is a tyrosine kinase inhibitor (TKI), currently approved as an oral tablet formulation to treat advanced renal cell carcinoma, that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. Clearside believes this broad VEGF blockade may have efficacy advantages over existing retinal therapies by acting at a different level of the angiogenesis cascade and may benefit patients who sub-optimally respond to current, more narrowly focused anti-VEGF therapies. Suprachoroidal injection of this proprietary suspension of axitinib has demonstrated meaningful potential in preclinical studies in multiple species and in a Phase 1/2a wet AMD clinical trial in which CLS-AX was well tolerated and demonstrated an excellent safety profile. With suprachoroidal administration of axitinib, there is the potential to achieve prolonged duration and targeted delivery to affected tissue layers while limiting drug exposure to the front of the eye. Clearside is developing CLS-AX as a long-acting therapy for the treatment of retinal diseases.