Author: Timothy Jackson (United Kingdom)
Co-authors: Allen Hu, Jeremiah Brown, Mark Humayun
Purpose
To assess the safety of intravitreal ONS-5010 bevacizumab-vikg.
Setting/Venue
20 US retinal clinics.
Methods
This was a prospective, multi-center, open-label, single-arm, interventional clinical trial. Up to 3 doses of intravitreal 1.25 mg (50 µL) ONS-5010 were administered monthly with follow up to 3 months. The key inclusion criteria were treatment-naïve or previously-treated, active wet age-related macular degeneration (AMD), diabetic macular oedema (DMO), or branch retinal vein occlusion (BRVO) requiring anti-VEGF therapy, and best-corrected visual acuity of ≥ 20 ETDRS letters. The analysis included all participants who received at least one dose of ONS-5010. Follow-up data were collected monthly. The frequency of adverse events (AEs) was collected, as well as safety parameters from ocular and systemic safety assessments.
Results
A total of 197 participants (65 with wet AMD, 108 DMO and 24 BRVO) received at least one dose of ONS-5010, with 192 (97.5%) completing the 3-month study. At least 1 AE was reported in 62 (31.5%) participants; 20 (10.2%) had study eye AEs of which 12 (6.1%) were deemed related to study treatment by the Investigator. AEs reported in ≥ 2% of participants comprised urinary tract infection, COVID-19, fall, and conjunctival hemorrhage. Conjunctival hemorrhage was the most commonly reported ocular AE (5 AEs in 4 participants). No AEs related to intraocular inflammation were reported. Eleven (5.6%) participants had serious AEs; none were related. One unrelated SAE was ocular (retinal hemorrhage). At day 90, 188 (97.9%) participants lost fewer than 15 letters compared to baseline.
Conlusions
The ONS-5010 safety profile is consistent with prior ophthalmic studies of bevacizumab. This supports the continued development of ONS-5010 for the treatment of wet AMD, DMO and BRVO. Subject to further testing and marketing authorization, an on-label, ophthalmic formulation of bevacizumab would increase the treatment options available to patients, clinicians and healthcare funders.
Financial Disclosure
Consultant to Outlook Therapeutics (Brown, Jackson, Hu); Paid Medical Advisor to Outlook Therapeutics (Humayun).
Comments
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