Name: Lytenava (bevacizumab-vikg) in Neovascular age-related macular degeneration: Product comparison
Published: 2026-09-28T12:24:10-04:00

NORSE TWO: LYTENAVA versus ranibizumab, dosing regimens and primary endpoint at Month 11

“In NORSE TWO, adult patients with nAMD were randomized to LYTENAVA 1.25 mg (N=113) administered once monthly for 1 year or ranibizumab 0.5 mg (N=115) administered once monthly for 3 months (Days 0, 30, and 60) followed by once every 3 months for 1 year (Days 150 and 240). Patient ages ranged from 54 to 98 years, with a median age of 79 years.” (opens the prescribing information at this quote)
“The primary efficacy endpoint was the proportion of patients who gained ≥ 15 Best Corrected Visual Acuity (BCVA) letters from baseline to Month 11 as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score. The difference observed between the study drug groups was significant, in favor of LYTENAVA (see Table 2).” (opens the prescribing information at this quote)

NORSE TWO: patients gaining 15 or more ETDRS letters at 11 months

Field	LYTENAVA 1.25 mg once monthly (N = 113)	Ranibizumab 0.5 mg once monthly x 3 months then every 3 months (N = 115)
Number of subjects, n/N (%)	“45/108 (41.7)”	“24/104 (23.1)”

NORSE TWO: risk difference between LYTENAVA and ranibizumab

“Risk difference 0.1859 95% CI 0.0442, 0.3086” (opens the prescribing information at this quote)

NORSE EIGHT: LYTENAVA versus ranibizumab, non-inferiority at Week 8

“In a multicenter, randomized, masked, controlled study (NORSE EIGHT – NCT06190093), 400 adult patients with nAMD were randomized (1:1) to LYTENAVA 1.25 mg or ranibizumab 0.5 mg, administered every 4 weeks for 3 total doses (Day 0, Week 4, and Week 8). The primary efficacy endpoint was the mean change in baseline BCVA as measured by ETDRS score at Week 8 using a non-inferiority (NI) margin of -3.5 letters.” (opens the prescribing information at this quote)
“NORSE EIGHT did not meet its pre-specified NI margin of -3.5 letters in mean change from baseline BCVA at Week 8 compared to ranibizumab.” (opens the prescribing information at this quote)
“At Week 8, the LYTENAVA group had a mean increase in BCVA of 3.3 compared to a mean increase of 4.5 in the ranibizumab group. The LS mean difference and 95% CI was -2.3 (-4.0, -0.5).” (opens the prescribing information at this quote)
“LYTENAVA showed an increase from baseline in BCVA at Week 12 consistent with NORSE TWO.” (opens the prescribing information at this quote)

Comparison with unapproved compounded bevacizumab

“Because no FDA-approved ophthalmic formulations of bevacizumab are available currently, clinicians wishing to treat retinal patients with bevacizumab have had to use unapproved repackaged IV bevacizumab provided by compounding pharmacies—products that have known risks of contamination and inconsistent potency and availability. If approved, ONS-5010 would provide an FDA-approved option for physicians that currently have no choice but to prescribe unapproved repackaged oncologic IV bevacizumab from compounding pharmacies for the treatment of wet AMD.” (opens the source at this quote in a new tab)

“Rather than relying on repackaged formulations originally intended for intravenous use, physicians now have access to a purpose-built ophthalmic formulation of bevacizumab designed specifically for intravitreal administration that delivers the manufacturing consistency, product quality, and regulatory oversight patients deserve.” (opens the source at this quote in a new tab)
“Bevacizumab already accounts for the majority of first-line anti-VEGF treatment in wet AMD, underscoring its important role in retina care.” (opens the source at this quote in a new tab)

Market size and competitive landscape

“The U.S. anti-VEGF retina market is estimated at approximately $8.5 billion annually, with millions of intravitreal injections administered every year.” (opens the source at this quote in a new tab)

“The Company's launch and go-to-market strategy is designed to reflect the evolving biosimilar landscape, affordability considerations, and the potential for additional market entrants, while supporting broad patient access and reimbursement.” (opens the source at this quote in a new tab)