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For US Healthcare Professionals

CIMERLI® is the first and only FDA-approved biosimilar interchangeable with Lucentis® (ranibizumab injection) for all indications1

CIMERLI® has attributes identical to Lucentis®2,3:

  • Same FDA-approved indications
  • Same dosage strengths
    (0.3 mg & 0.5 mg)
  • Same formulation &
    excipients
  • Same amino
    acid sequence

Rigorous FDA determination of biosimilarity is based on the totality of evidence4

Biosimilarity

CIMERLI® was proven to be biosimilar to Lucentis®3,5

PharmacodynamicsCIMERLI®Lucentis®Biological functionSafety profilePharmacokineticsImmunogenicityDrug purityDrug stability
CIMERLI®Lucentis®Biological functionSafety profilePharmacokineticsImmunogenicityDrug purityPharmacodynamicsDrug stability

CIMERLI® was proven to be highly similar to Lucentis® with no clinically meaningful differences5

Totality of Evidence4

CIMERLI® meets rigorous FDA requirements for biosimilarity

Comparative analytical assessments

Demonstrate similarity of the key relevant structural and functional quality attributes of CIMERLI® to Lucentis®3

Non-clinical studies

Establish ocular pharmacokinetics comparable to Lucentis® in rabbit model (within the vitreous humor)3

Comparative clinical study

Demonstrate no clinically meaningful differences in terms of efficacy, safety, and immunogenicity, as well as pharmacokinetic and pharmacodynamic evaluation in wAMD patients (COLUMBUS-AMD study)3,5

CIMERLI is approved for wAMD, DR, DME, macular edema following RVO, and mCNV2

DR, diabetic retinopathy; DME, diabetic macular edema; RVO, retinal vein occlusion; mCNV, myopic choroidal neovascularization; wAMD, neovascular (wet) age-related macular degeneration.

Interchangeability

Two bottles of medicine on a scale

CIMERLI® is the first and only biosimilar interchangeable with Lucentis® for all FDA-approved indications1

Approved as an interchangeable biosimilar,1 CIMERLI® can be expected3,4:

  • To produce the same clinical results as Lucentis® in any given patient and for all FDA-approved indications
  • To not increase risk, in terms of safety or reduction of efficacy, when alternating or switching from Lucentis®

‟FDA’s high standards for approval should assure healthcare providers that they can be confident in the safety and effectiveness of the interchangeable product, just as they would for an FDA-approved reference product.”4

—U.S. Food & Drug Administration

CIMERLI® met additional FDA requirements to gain interchangeability designation1,3

Totality of Evidence

  • CIMERLI® demonstrated biosimilarity to Lucentis®

With these additional factors to support interchangeability:

  • CIMERLI® is a product with relatively low complexity [e.g., no glycosylation]
  • CIMERLI® has low incidence of immunogenicity (along with no history of ranibizumab inducing severe immune responses)
  • CIMERLI®-related serious adverse events were comparable to Lucentis®

When alternating or switching between CIMERLI® and Lucentis®:

  • Risk of clinically impactful immunogenic response from systemic anti-drug antibodies does not increase
  • Risk of intraocular inflammation is expected to be consistent with ranibizumab product use

Be confident CIMERLI® can be substituted for Lucentis® in any given patient.

A head-to-head study of CIMERLI® vs reference product Lucentis® published in Ophthalmology, the journal of the American Academy of Ophthalmology.

The COLUMBUS-AMD comparative study4

A head-to-head study of CIMERLI® vs reference product Lucentis® published in Ophthalmology, the journal of the American Academy of Ophthalmology.

Study Design

  • A prospective 48-week, evaluation-masked, parallel-group, global, multicenter, randomized study in patients with treatment-naïve, subfoveal CNV due to wAMD
  • Patient characteristics were well balanced between study arms:
    • ≥50 years
    • Subfoveal or juxtafoveal CNV with foveal-involving leakage related to CNV activity
    • FCP retinal thickness ≥350 µm on SD-OCT
    • Total lesion area of ≤12 MPS disc areas
    • Total CNV area ≥50% of total lesion area
    • Study eye BCVA 20/32
      to 20/100
PrimaryChange in BCVA from baseline at Week 8Key SecondaryChange in BCVA from baseline at Week 48, change in retina thickness from baseline at Week 48, safety and immunogenicityEndpointsR 1:1n=477Treatment: CIMERLI™IVT 0.5 mg (50 μL) Q4W for ≤48 weeksn=238Reference Product: Lucentis®IVT 0.5 mg (50 μL) Q4W for ≤48 weeksn=239
EndpointsPrimaryChange in BCVA from baseline at Week 8*Key SecondaryChange in BCVA from baseline at Week 48, change in retina thickness from baseline at Week 48, safety and immunogenicityTreatment: CIMERLI™IVT 0.5 mg (50 μL) Q4W for ≤48 weeksn=238Reference Product: Lucentis®IVT 0.5 mg (50 μL) Q4W for ≤48 weeksn=239R 1:1n=477

*FDA required primary endpoint selection of BCVA at 8 weeks4,5

The 8-week primary endpoint is considered to be highly sensitive to detect any difference between the biosimilar and reference product because rate of improvement in visual acuity is particularly steep during the first 8 weeks. Odds of observing a true difference in efficacy between CIMERLI® and Lucentis® would be seen during this timeframe.

BCVA, best corrected visual acuity; CNV, choroidal neovascularization; ETDRS, Early Treatment Diabetic Retinopathy Study; FCP, foveal center point; IVT, intravitreal; MPS, macular photocoagulation study; wAMD, neovascular (wet) age-related macular degeneration; Q4W, every 4 weeks; R, randomized; SD-OCT, spectral domain optical coherence tomography.

CIMERLI® head-to-head trial established clinical equivalence to Lucentis®

Proven vision gains at 8 weeks and
sustained through Week 484

Primary endpoint:
BCVA improved in both CIMERLI® and Lucentis® treatment groups with an average of 5 more ETDRS letters at 8 weeks.

Secondary endpoint:
BCVA improved in both CIMERLI® and Lucentis® treatment groups with an average of 8 more ETDRS letters at 48 weeks.

CIMERLI®Lucentis®Time (weeks)Adjusted mean BCVA change4Baseline812162024283236404448051015PrimaryEndpointSustainedVisionGains
SustainedvisiongainsTime (weeks)Adjusted mean BCVA change4Baseline812162024283236404448051015PrimaryendpointCIMERLI®Lucentis®+5ETDRSletters
Zoom

Proven vision gains at 8 weeks and
sustained through Week 484

Secondary Endpoint:
Patients in both treatment groups experienced highly similar reductions in FCP and FCS retinal thickness, as well as total lesion area.

FCP thickness chart
CIMERLI™Lucentis®
Zoom

FCP Thickness:
Mean reduction from baseline of 213.3 µm CIMERLI® and 211.0 µm Lucentis® at Week 48.

CIMERLI®Lucentis®
Zoom

FCS Thickness:
Mean reduction from baseline of 182.9 µm CIMERLI® and 190.8 µm Lucentis® at Week 48.

FCP=foveal center point; FCS=foveal central subfield.

Take a closer look at the head-to-head trial results between CIMERLI® and Lucentis®

Review the COLUMBUS-AMD Publication (opens in a new tab)Download the COLUMBUS-AMD Presentation (opens in a new tab)

CIMERLI® demonstrated a comparable safety profile to Lucentis®4

No clinical differences in adverse events were observed between CIMERLI® and Lucentis®
AdverseReactionCIMERLI®% (n=238)Lucentis®% (n=239)CataractReduced Visual AcuityVitreousHemorrhageIntraocularInflammation*2.1% (5)1.3% (3)0.4% (1)0.8% (2)0.0% (0)0.0% (0)0.4% (1)0.8% (2)1.3% (3)0.8% (2)0.0% (0)0.4% (1)0.4% (1)1.3% (3)0.8% (2)0.4% (1)Retinal Pigment Epithelium TearIncreasedIntraocularPressureEye PainIncreasedGamma-GlutamylTransferase LevelMost frequently observed drug-related adverse events (AEs)
Adverse ReactionCIMERLI®% (n=238)Lucentis®% (n=239)CataractReduced Visual AcuityVitreous HemorrhageIntraocular Inflammation*2.1% (5)1.3% (3)0.4% (1)0.8% (2)0.0% (0)0.0% (0)0.4% (1)0.8% (2)1.3% (3)0.8% (2)0.0% (0)0.4% (1)0.4% (1)1.3% (3)0.8% (2)0.4% (1)Retinal Pigment Epithelium TearIncreased Intraocular PressureEye PainIncreased Gamma-GlutamylTransferase LevelMost frequently observed drug-related adverse events (AEs)

*Among CIMERLI® patients, one case of iridocyclitis and one case of conjunctivitis were observed;
two cases of punctate keratitis were observed among Lucentis® patients.

CIMERLI® demonstrated an immunogenicity profile comparable to Lucentis®4

  • Few patients developed anti-drug antibodies (ADAs) during the study and had similar levels of ADA titers across treatment arms†
  • No neutralizing antibodies (NAbs) were detected up to Week 24
    • 1 patient tested positive for NAbs up to Week 48 (CIMERLI®)

†The clinical significance of immunoreactivity to ranibizumab is unclear at this time.

Incidence of Anti-Drug Antibodies
Incidence of Anti-Drug Antibodies

Injection-site reactions are common with intravitreal injections2

Serious side effects include infections inside of the eye and detached retinas that may cause:

  • Blurry vision
  • Light sensitivity
  • Cloudy vision

Some patients have had increased eye pressure before and within 1 hour of an injection.

Uncommonly, CIMERLI® patients have had serious, sometimes fatal, problems related to blood clots, such as heart attacks or strokes. Although there were only a few fatal events, which included causes of death typical of patients with advanced diabetic complications, these events may be caused by CIMERLI®.

The most common eye-related side effects are:

  • Conjunctival hemorrhage
  • Eye pain
  • Eye floaters
  • Increased intraocular pressure

The most common non-eye related side effects are:

  • Nasopharyngitis
  • Anemia
  • Nausea

See the CIMERLI® Important Safety Information and the CIMERLI® Prescribing Information (opens in a new tab) for more information on side effects.

See Head-to-head Data »Review Safety Data »
Review CIMERLI® Totality of Evidence »See safety data »
Review CIMERLI® Totality of Evidence »See Head-to-head Data »

CIMERLI® has the same dosing as Lucentis®2,6®2,6®2,5

See Prescribing Information (opens in a new tab)

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Important Safety Information

Important Safety Information

CONTRAINDICATIONS: CIMERLI® (ranibizumab-eqrn) is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab products or any of the excipients in CIMERLI®. Hypersensitivity reactions may manifest as severe intraocular inflammation.

WARNINGS AND PRECAUTIONS

  • Endophthalmitis and Retinal Detachments: Intravitreal injections, including those with ranibizumab products, have been associated with endophthalmitis, retinal detachment, and iatrogenic traumatic cataract. Proper aseptic injection technique should always be utilized when administering CIMERLI®. In addition, patients should be monitored following the injection to permit early treatment, should an infection occur
  • Increases in Intraocular Pressure: Increases in intraocular pressure have been noted both pre-injection and post-injection (at 60 minutes) while being treated with ranibizumab products. Monitor intraocular pressure prior to and following intravitreal injection with CIMERLI® and manage appropriately
  • Thromboembolic Events: Although there was a low rate of arterial thromboembolic events (ATEs) observed in the ranibizumab clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause)

Neovascular (Wet) Age-Related Macular Degeneration (wAMD)

  • The ATE rate in the three controlled neovascular AMD studies (AMD-1, AMD-2, AMD-3) during the first year was 1.9% (17 of 874) in the combined group of patients treated with 0.3 mg or 0.5 mg ranibizumab compared with 1.1% (5 of 441) in patients from the control arms. In the second year of Studies AMD-1 and AMD-2, the ATE rate was 2.6% (19 of 721) in the combined group of ranibizumab-treated patients compared with 2.9% (10 of 344) in patients from the control arms. In Study AMD-4, the ATE rates observed in the 0.5 mg arms during the first and second year were similar to rates observed in Studies AMD-1, AMD-2, and AMD-3
  • In a pooled analysis of 2-year controlled studies (AMD-1, AMD-2, and a study of ranibizumab used adjunctively with verteporfin photodynamic therapy), the stroke rate (including both ischemic and hemorrhagic stroke) was 2.7% (13 of 484) in patients treated with 0.5 mg ranibizumab compared to 1.1% (5 of 435) in patients in the control arms (odds ratio 2.2 [95% confidence interval (0.8-7.1)])

Macular Edema Following Retinal Vein Occlusion (RVO)

  • The ATE rate in the two controlled RVO studies during the first 6 months was 0.8% in both the ranibizumab and control arms of the studies (4 of 525 in the combined group of patients treated with 0.3 mg or 0.5 mg ranibizumab and 2 of 260 in the control arms). The stroke rate was 0.2% (1 of 525) in the combined group of ranibizumab-treated patients compared to 0.4% (1 of 260) in the control arms

Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR)

  • In a pooled analysis of Studies D-1 and D-2, the ATE rate at 2 years was 7.2% (18 of 250) with 0.5 mg ranibizumab, 5.6% (14 of 250) with 0.3 mg ranibizumab, and 5.2% (13 of 250) with control. The stroke rate at 2 years was 3.2% (8 of 250) with 0.5 mg ranibizumab, 1.2% (3 of 250) with 0.3 mg ranibizumab, and 1.6% (4 of 250) with control. At 3 years, the ATE rate was 10.4% (26 of 249) with 0.5 mg ranibizumab and 10.8% (27 of 250) with 0.3 mg ranibizumab; the stroke rate was 4.8% (12 of 249) with 0.5 mg ranibizumab and 2.0% (5 of 250) with 0.3 mg ranibizumab
  • Fatal events occurred more frequently in patients with DME and DR at baseline: A pooled analysis of Studies D-1 and D-2 showed that fatalities in the first 2 years occurred in 4.4% (11 of 250) of patients treated with 0.5 mg ranibizumab, in 2.8% (7 of 250) of patients treated with 0.3 mg ranibizumab, and in 1.2% (3 of 250) of control patients. Over 3 years, fatalities occurred in 6.4% (16 of 249) of patients treated with 0.5 mg ranibizumab and in 4.4% (11 of 250) of patients treated with 0.3 mg ranibizumab. Although the rate of fatal events was low and included causes of death typical of patients with advanced diabetic complications, a potential relationship between these events and intravitreal use of VEGF inhibitors cannot be excluded
  • Retinal vasculitis with or without occlusion, typically in the presence of preexisting intraocular inflammation or post-treatment with other intravitreal agents, have been reported with the use of ranibizumab products. Discontinue treatment with CIMERLI® in patients who develop these events. Patients should be instructed to report any change in vision without delay

ADVERSE REACTIONS

  • Serious adverse reactions related to the injection procedure that occurred in <0.1% of intravitreal injections, including endophthalmitis, rhegmatogenous retinal detachment, and iatrogenic traumatic cataract
  • The most frequently reported ocular adverse reactions in ranibizumab-treated patients compared with the control group were conjunctival hemorrhage, eye pain, vitreous floaters, and increased intraocular pressure. The most common non-ocular adverse reactions were nasopharyngitis, anemia, nausea, and cough
  • As with all therapeutic proteins, there is the potential for an immune response in patients treated with ranibizumab products. The clinical significance of immunoreactivity to ranibizumab products is unclear at this time

Postmarketing Experience

The following adverse reaction has been identified during post-approval use of ranibizumab products:

  • Ocular: Tear of retinal pigment epithelium among patients with neovascular AMD

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz, Inc at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch (opens in a new tab).

Before prescribing, please see CIMERLI® Prescribing Information (opens in a new tab).

Indications

Indications

CIMERLI® is indicated for the treatment of patients with:

  • Neovascular (wet) Age-Related Macular Degeneration (wAMD)
  • Macular Edema Following Retinal Vein Occlusion (RVO)
  • Diabetic Macular Edema (DME)
  • Diabetic Retinopathy (DR)
  • Myopic Choroidal Neovascularization (mCNV)

References:

  1. Purple Book Database of Licensed Biological Products. U.S. Food and Drug Administration. https://purplebooksearch.fda.gov/faqs. Updated 2024. Accessed on June 4, 2024.
  2. CIMERLI® (ranibizumab-eqrn) prescribing information. Princeton, NJ: Sandoz, Inc.; 2024.
  3. Data on file. Sandoz, Inc.
  4. Considerations in demonstrating interchangeability with a reference product. U.S. Food and Drug Administration. https://www.fda.gov/media/124907/download. Published 2019. Accessed on February 24, 2022.
  5. Holz FG, Oleksy P, Ricci F, et al. Efficacy and Safety of Biosimilar FYB201 Compared with Ranibizumab in Neovascular Age-Related Macular Degeneration. Ophthalmology. 2022;129(1):54-63. doi:10.1016/j.ophtha.2021.04.031
  6. Lucentis® (ranibizumab injection) prescribing information. South San Francisco, CA: Genentech, Inc.; 2024.

References:

  1. Purple Book Database of Licensed Biological Products. U.S. Food and Drug Administration. https://purplebooksearch.fda.gov/faqs. Updated 2024. Accessed on June 4, 2024.
  2. CIMERLI® (ranibizumab-eqrn) prescribing information. Princeton, NJ: Sandoz, Inc.; 2024.
  3. Data on file. Sandoz, Inc.
  4. Holz FG, Oleksy P, Ricci F, et al. Efficacy and Safety of Biosimilar FYB201 Compared with Ranibizumab in Neovascular Age-Related Macular Degeneration. Ophthalmology. 2022;129(1):54-63. doi:10.1016/j.ophtha.2021.04.031
  5. Bressler S, Hepp R. The Biosimilar Market: What You Need to Know. Retina Today. https://retinatoday.com/articles/2022-may-june/the-biosimilar-market-what-you-need-to-know. Published 2022. Accessed on June 14, 2022.
  6. Lucentis® (ranibizumab injection) prescribing information. South San Francisco, CA: Genentech, Inc.; 2024.

References:

  1. Purple Book Database of Licensed Biological Products. U.S. Food and Drug Administration. https://purplebooksearch.fda.gov/faqs. Updated 2024. Accessed on June 4, 2024.
  2. CIMERLI® (ranibizumab-eqrn) prescribing information. Princeton, NJ: Sandoz, Inc.; 2024.
  3. Data on file. Sandoz, Inc.
  4. Holz FG, Oleksy P, Ricci F, et al. Efficacy and Safety of Biosimilar FYB201 Compared with Ranibizumab in Neovascular Age-Related Macular Degeneration. Ophthalmology. 2022;129(1):54-63. doi:10.1016/j.ophtha.2021.04.031
  5. Lucentis® (ranibizumab injection) prescribing information. South San Francisco, CA: Genentech, Inc.; 2024.

Important Safety Information

Important Safety Information

CONTRAINDICATIONS: CIMERLI® (ranibizumab-eqrn) is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab products or any of the excipients in CIMERLI®. Hypersensitivity reactions may manifest as severe intraocular inflammation.

WARNINGS AND PRECAUTIONS

  • Endophthalmitis and Retinal Detachments: Intravitreal injections, including those with ranibizumab products, have been associated with endophthalmitis, retinal detachment, and iatrogenic traumatic cataract. Proper aseptic injection technique should always be utilized when administering CIMERLI®. In addition, patients should be monitored following the injection to permit early treatment, should an infection occur
  • Increases in Intraocular Pressure: Increases in intraocular pressure have been noted both pre-injection and post-injection (at 60 minutes) while being treated with ranibizumab products. Monitor intraocular pressure prior to and following intravitreal injection with CIMERLI® and manage appropriately
  • Thromboembolic Events: Although there was a low rate of arterial thromboembolic events (ATEs) observed in the ranibizumab clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause)

Neovascular (Wet) Age-Related Macular Degeneration (wAMD)

  • The ATE rate in the three controlled neovascular AMD studies (AMD-1, AMD-2, AMD-3) during the first year was 1.9% (17 of 874) in the combined group of patients treated with 0.3 mg or 0.5 mg ranibizumab compared with 1.1% (5 of 441) in patients from the control arms. In the second year of Studies AMD-1 and AMD-2, the ATE rate was 2.6% (19 of 721) in the combined group of ranibizumab-treated patients compared with 2.9% (10 of 344) in patients from the control arms. In Study AMD-4, the ATE rates observed in the 0.5 mg arms during the first and second year were similar to rates observed in Studies AMD-1, AMD-2, and AMD-3
  • In a pooled analysis of 2-year controlled studies (AMD-1, AMD-2, and a study of ranibizumab used adjunctively with verteporfin photodynamic therapy), the stroke rate (including both ischemic and hemorrhagic stroke) was 2.7% (13 of 484) in patients treated with 0.5 mg ranibizumab compared to 1.1% (5 of 435) in patients in the control arms (odds ratio 2.2 [95% confidence interval (0.8-7.1)])

Macular Edema Following Retinal Vein Occlusion (RVO)

  • The ATE rate in the two controlled RVO studies during the first 6 months was 0.8% in both the ranibizumab and control arms of the studies (4 of 525 in the combined group of patients treated with 0.3 mg or 0.5 mg ranibizumab and 2 of 260 in the control arms). The stroke rate was 0.2% (1 of 525) in the combined group of ranibizumab-treated patients compared to 0.4% (1 of 260) in the control arms

Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR)

  • In a pooled analysis of Studies D-1 and D-2, the ATE rate at 2 years was 7.2% (18 of 250) with 0.5 mg ranibizumab, 5.6% (14 of 250) with 0.3 mg ranibizumab, and 5.2% (13 of 250) with control. The stroke rate at 2 years was 3.2% (8 of 250) with 0.5 mg ranibizumab, 1.2% (3 of 250) with 0.3 mg ranibizumab, and 1.6% (4 of 250) with control. At 3 years, the ATE rate was 10.4% (26 of 249) with 0.5 mg ranibizumab and 10.8% (27 of 250) with 0.3 mg ranibizumab; the stroke rate was 4.8% (12 of 249) with 0.5 mg ranibizumab and 2.0% (5 of 250) with 0.3 mg ranibizumab
  • Fatal events occurred more frequently in patients with DME and DR at baseline: A pooled analysis of Studies D-1 and D-2 showed that fatalities in the first 2 years occurred in 4.4% (11 of 250) of patients treated with 0.5 mg ranibizumab, in 2.8% (7 of 250) of patients treated with 0.3 mg ranibizumab, and in 1.2% (3 of 250) of control patients. Over 3 years, fatalities occurred in 6.4% (16 of 249) of patients treated with 0.5 mg ranibizumab and in 4.4% (11 of 250) of patients treated with 0.3 mg ranibizumab. Although the rate of fatal events was low and included causes of death typical of patients with advanced diabetic complications, a potential relationship between these events and intravitreal use of VEGF inhibitors cannot be excluded
  • Retinal vasculitis with or without occlusion, typically in the presence of preexisting intraocular inflammation or post-treatment with other intravitreal agents, have been reported with the use of ranibizumab products. Discontinue treatment with CIMERLI® in patients who develop these events. Patients should be instructed to report any change in vision without delay

ADVERSE REACTIONS

  • Serious adverse reactions related to the injection procedure that occurred in <0.1% of intravitreal injections, including endophthalmitis, rhegmatogenous retinal detachment, and iatrogenic traumatic cataract
  • The most frequently reported ocular adverse reactions in ranibizumab-treated patients compared with the control group were conjunctival hemorrhage, eye pain, vitreous floaters, and increased intraocular pressure. The most common non-ocular adverse reactions were nasopharyngitis, anemia, nausea, and cough
  • As with all therapeutic proteins, there is the potential for an immune response in patients treated with ranibizumab products. The clinical significance of immunoreactivity to ranibizumab products is unclear at this time

Postmarketing Experience

The following adverse reaction has been identified during post-approval use of ranibizumab products:

  • Ocular: Tear of retinal pigment epithelium among patients with neovascular AMD

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz, Inc at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch (opens in a new tab).

Before prescribing, please see CIMERLI® Prescribing Information (opens in a new tab).

Indications

Indications

CIMERLI® is indicated for the treatment of patients with:

  • Neovascular (wet) Age-Related Macular Degeneration (wAMD)
  • Macular Edema Following Retinal Vein Occlusion (RVO)
  • Diabetic Macular Edema (DME)
  • Diabetic Retinopathy (DR)
  • Myopic Choroidal Neovascularization (mCNV)

Important Safety Information

CONTRAINDICATIONS: CIMERLI® (ranibizumab-eqrn) is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab products or any of the excipients in CIMERLI®. Hypersensitivity reactions may manifest as severe intraocular inflammation.

Important Safety Information

Important Safety Information

CONTRAINDICATIONS: CIMERLI® (ranibizumab-eqrn) is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab products or any of the excipients in CIMERLI®. Hypersensitivity reactions may manifest as severe intraocular inflammation.

WARNINGS AND PRECAUTIONS

  • Endophthalmitis and Retinal Detachments: Intravitreal injections, including those with ranibizumab products, have been associated with endophthalmitis, retinal detachment, and iatrogenic traumatic cataract. Proper aseptic injection technique should always be utilized when administering CIMERLI®. In addition, patients should be monitored following the injection to permit early treatment, should an infection occur
  • Increases in Intraocular Pressure: Increases in intraocular pressure have been noted both pre-injection and post-injection (at 60 minutes) while being treated with ranibizumab products. Monitor intraocular pressure prior to and following intravitreal injection with CIMERLI® and manage appropriately
  • Thromboembolic Events: Although there was a low rate of arterial thromboembolic events (ATEs) observed in the ranibizumab clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause)

Neovascular (Wet) Age-Related Macular Degeneration (wAMD)

  • The ATE rate in the three controlled neovascular AMD studies (AMD-1, AMD-2, AMD-3) during the first year was 1.9% (17 of 874) in the combined group of patients treated with 0.3 mg or 0.5 mg ranibizumab compared with 1.1% (5 of 441) in patients from the control arms. In the second year of Studies AMD-1 and AMD-2, the ATE rate was 2.6% (19 of 721) in the combined group of ranibizumab-treated patients compared with 2.9% (10 of 344) in patients from the control arms. In Study AMD-4, the ATE rates observed in the 0.5 mg arms during the first and second year were similar to rates observed in Studies AMD-1, AMD-2, and AMD-3
  • In a pooled analysis of 2-year controlled studies (AMD-1, AMD-2, and a study of ranibizumab used adjunctively with verteporfin photodynamic therapy), the stroke rate (including both ischemic and hemorrhagic stroke) was 2.7% (13 of 484) in patients treated with 0.5 mg ranibizumab compared to 1.1% (5 of 435) in patients in the control arms (odds ratio 2.2 [95% confidence interval (0.8-7.1)])

Macular Edema Following Retinal Vein Occlusion (RVO)

  • The ATE rate in the two controlled RVO studies during the first 6 months was 0.8% in both the ranibizumab and control arms of the studies (4 of 525 in the combined group of patients treated with 0.3 mg or 0.5 mg ranibizumab and 2 of 260 in the control arms). The stroke rate was 0.2% (1 of 525) in the combined group of ranibizumab-treated patients compared to 0.4% (1 of 260) in the control arms

Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR)

  • In a pooled analysis of Studies D-1 and D-2, the ATE rate at 2 years was 7.2% (18 of 250) with 0.5 mg ranibizumab, 5.6% (14 of 250) with 0.3 mg ranibizumab, and 5.2% (13 of 250) with control. The stroke rate at 2 years was 3.2% (8 of 250) with 0.5 mg ranibizumab, 1.2% (3 of 250) with 0.3 mg ranibizumab, and 1.6% (4 of 250) with control. At 3 years, the ATE rate was 10.4% (26 of 249) with 0.5 mg ranibizumab and 10.8% (27 of 250) with 0.3 mg ranibizumab; the stroke rate was 4.8% (12 of 249) with 0.5 mg ranibizumab and 2.0% (5 of 250) with 0.3 mg ranibizumab
  • Fatal events occurred more frequently in patients with DME and DR at baseline: A pooled analysis of Studies D-1 and D-2 showed that fatalities in the first 2 years occurred in 4.4% (11 of 250) of patients treated with 0.5 mg ranibizumab, in 2.8% (7 of 250) of patients treated with 0.3 mg ranibizumab, and in 1.2% (3 of 250) of control patients. Over 3 years, fatalities occurred in 6.4% (16 of 249) of patients treated with 0.5 mg ranibizumab and in 4.4% (11 of 250) of patients treated with 0.3 mg ranibizumab. Although the rate of fatal events was low and included causes of death typical of patients with advanced diabetic complications, a potential relationship between these events and intravitreal use of VEGF inhibitors cannot be excluded
  • Retinal vasculitis with or without occlusion, typically in the presence of preexisting intraocular inflammation or post-treatment with other intravitreal agents, have been reported with the use of ranibizumab products. Discontinue treatment with CIMERLI® in patients who develop these events. Patients should be instructed to report any change in vision without delay

ADVERSE REACTIONS

  • Serious adverse reactions related to the injection procedure that occurred in <0.1% of intravitreal injections, including endophthalmitis, rhegmatogenous retinal detachment, and iatrogenic traumatic cataract
  • The most frequently reported ocular adverse reactions in ranibizumab-treated patients compared with the control group were conjunctival hemorrhage, eye pain, vitreous floaters, and increased intraocular pressure. The most common non-ocular adverse reactions were nasopharyngitis, anemia, nausea, and cough
  • As with all therapeutic proteins, there is the potential for an immune response in patients treated with ranibizumab products. The clinical significance of immunoreactivity to ranibizumab products is unclear at this time

Postmarketing Experience

The following adverse reaction has been identified during post-approval use of ranibizumab products:

  • Ocular: Tear of retinal pigment epithelium among patients with neovascular AMD

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz, Inc at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch (opens in a new tab).

Before prescribing, please see CIMERLI® Prescribing Information (opens in a new tab).

Indications

CIMERLI® is indicated for the treatment of patients with:

  • Neovascular (wet) age-related macular degeneration (wAMD)
  • Macular Edema Following Retinal Vein Occlusion (RVO)

Indications

Indications

Indications

CIMERLI® is indicated for the treatment of patients with:

  • Neovascular (wet) Age-Related Macular Degeneration (wAMD)
  • Macular Edema Following Retinal Vein Occlusion (RVO)
  • Diabetic Macular Edema (DME)
  • Diabetic Retinopathy (DR)
  • Myopic Choroidal Neovascularization (mCNV)

Proven vision gains at 8 weeks
and sustained through Week 484

Bar Chart: Vision gains at 8 weeks and sustained through Week 483

Proven vision gains at 8 weeks
and sustained through Week 484

Bar Chart: Reduction in FCP retinal thickness

Study Week

Proven vision gains at 8 weeks
and sustained through Week 484

Bar Chart: Reduction in FCS retinal thickness

Study Week

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