BIOGEN

Is It Possible to Give More Patients With Retinal Vascular Disorders a Chance to See Their World?

BIOGEN

A biosimilar* referencing PrLUCENTIS (ranibizumab injection) ¹

Approved for the treatment of 1 :
nAMD DME CNV
macular edema
secondary to RVO

*A biosimilar biologic drug, or biosimilar, is a biologic drug that is highly similar to a biologic drug that was already authorised for sale. There are no expected clinically meaningful differences in efcacy and safety between a biosimilar and the biologic drug that was already authorised for sale.2 LUCENTIS is a trademark of Genentech, Inc. Indication and clinical use: BYOOVIZ (ranibizumab) is indicated for the treatment of: - neovascular (wet) age-related macular degeneration (AMD). - visual impairment due to: CNV=choroidal neovascularisation; DME=diabetic macular oedema; nAMD=neovascular age-related macular degeneration; RVO=retinal vein occlusion.

There’s So Much
More to See

BIOGEN

Clinical Trial Results:

Similar Efficacy and
Comparable Safety Proﬁle
to LUCENTIS^1-4

PRIMARY ENDPOINTS MET^1,2

(Weeks 4 and 8)

PRIMARY ENDPOINTS MET^1,2

(Weeks 4 and 8)

Change from baseline in:

CST at Week 4
BCVA at Week 8

BYOOVIZ met the primary endpoint in a phase 3 equivalence study¹

The treatment difference in BCVA of the change from baseline between BYOOVIZ and at Week 8 was letters and the 95% Cl was [-2.023, 0.415], which was contained within the pre-defined similarity margin of letters, [-3 letters, 3 letters]¹

BCVA=best corrected visual acuity (ETDRS letter score); CI=confidence interval; CST=central retinal subfield thickness; ETDRS=Early Treatment of Diabetic Retinopathy Study.

SECONDARY ENDPOINTS MET^2,3

(Weeks 24 and 52)

SECONDARY ENDPOINTS MET^1,2

(Weeks 24 and 52)

Change from baseline in:

CST
BCVA
CRLT
CNV size
Active CNV leakage (proportion of patients)

BCVA=best corrected visual acuity (ETDRS letter score); CNV=choroidal neovascularisation; CRLT=central retinal lesion thickness; CST=central retinal subﬁeld thickness; ETDRS=Early Treatment of Diabetic Retinopathy Study.

SAFETY PROFILE COMPARABLE TO LUCENTIS^1-4

(Most commonly reported adverse events)

SAFETY PROFILE COMPARABLE TO LUCENTIS^1-4

The types, frequency, and severity of adverse events were comparable between BYOOVIZ and the reference product LUCENTIS¹

No deﬁnitive diﬀerences in the overall incidence of AESIs between treatment groups were identiﬁed²
- Increased intraocular pressure (BYOOVIZ, 3 [0.9%]; LUCENTIS,
  6 [1.7%])²