Susvimo Drug Information

Generic name: RANIBIZUMAB

Vascular Endothelial Growth Factor Inhibitor [EPC]

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Uses of Susvimo

Neovascular (wet) Age-related Macular Degeneration (AMD)

SUSVIMO (ranibizumab injection) is indicated for the treatment of patients with Neovascular (wet) Age-related Macular Degeneration (AMD) who have previously responded to at least two intravitreal injections of a Vascular Endothelial Growth Factor (VEGF) inhibitor medication.

Diabetic Macular Edema (DME)

SUSVIMO (ranibizumab injection) is indicated for the treatment of patients with Diabetic Macular Edema (DME) who have previously responded to at least two intravitreal injections of a Vascular Endothelial Growth Factor (VEGF) inhibitor medication.

Diabetic Retinopathy (DR)

SUSVIMO (ranibizumab injection) is indicated for the treatment of patients with Diabetic Retinopathy (DR) who have previously responded to at least two intravitreal injections of a Vascular Endothelial Growth Factor (VEGF) inhibitor medication.

Dosage & Administration of Susvimo

Step 1: Gather the supplies needed. One SUSVIMO ocular implant with insertion tool assembly (included) One SUSVIMO initial fill needle (34-gauge with integrated 5 μm filter) with blue cap (included) One SUSVIMO (ranibizumab injection) 100 mg/mL vial (included) One sterile 5-micron filter needle (19-gauge × 1½ inch) (not included) One sterile 1 mL Luer Lock syringe (not included)
Step 2: Transfer Dose from Vial to Syringe
Note:	Use the filter needle (not included) to withdraw SUSVIMO (ranibizumab injection) from the vial.
Do not use the SUSVIMO initial fill needle for this step. Prepare SUSVIMO (ranibizumab injection) vial by removing the flip-off cap and disinfecting the rubber vial septum with alcohol. Attach a filter needle to the syringe by screwing it tightly onto the Luer lock (see Figure 1). Carefully remove the needle cap by pulling it straight off. Using aseptic technique, withdraw all of the contents of the SUSVIMO (ranibizumab injection) vial through the filter needle into the syringe.
Step 3: Remove Air from Syringe With the filter needle attached, hold the syringe with the needle pointing up. If there are any air bubbles, gently tap the syringe with your finger until the bubbles rise to the top (Figure 2). Slowly push the plunger rod just until all air is expelled from the syringe and needle. It is important to preserve as much drug as possible in order to completely fill the implant. Remove and properly dispose of the filter needle after air is removed from syringe.	Figure2
Step 4: Attach SUSVIMO Initial Fill Needle Do not use the filter needle to fill the implant. Attach the SUSVIMO initial fill needle (included) firmly onto the syringe by screwing it tightly onto the Luer lock (see Figure 3). Ensure that the initial fill needle is attached to the syringe. Carefully remove the needle cap by pulling straight off. Do not wipe the needle at any time.	Figure 3
Step 5: Remove Any Remaining Air from Syringe With the initial fill needle attached, hold the syringe with the needle pointing up. If there are any air bubbles, gently tap the syringe with your finger until the bubbles rise to the top (see Figure 4). Slowly push the plunger rod just until all air is expelled from the syringe and needle, and a drop of drug solution is seen at the needle tip (see Figure 5).	Figure 4 Figure 5
Note:	It is important to preserve as much drug as possible in order to completely fill the implant.
Step 6: Inspect the Syringe for Air Bubbles Inspect the syringe and the needle hub to ensure that no air bubbles are present (see Figure 6). If air bubbles are present, continue to remove air from the syringe and reinspect.	Figure 6
Note:	Use the syringe within 15 minutes of removing all air to avoid ranibizumab drying in the needle and impeding fluid flow. Do not use the initial fill needle if the needle is clogged.
Step 7: Load Syringe into the Carrier Do not hold or push on the plunger rod of the syringe while inserting the needle into the implant septum. Retrieve insertion tool carrier with pre-positioned implant from the inner tray. Align the syringe Luer lock above the Luer lock slot in the carrier to protect the needle from being damaged. Lower the syringe into the carrier (see Figure 7). Push the syringe forward until it stops, taking care to avoid touching the plunger rod (see Figure 8) With the syringe loaded, (see Figure 9) the initial fill needle should now be penetrating the implant septum.	Figure 7: Align and lower the syringe into the carrier Figure 8: Push the syringe into the carrier Figure 9: Syringe with initial fill needle inserted through the implant septum
Step 8: Fill Ocular Implant with SUSVIMO (ranibizumab injection) Under Microscope Under the microscope, slowly administer SUSVIMO (ranibizumab injection) into the ocular implant by slightly tilting the carrier upwards (see Figure 10). The ocular implant should be filled over approximately 5 to 10 seconds, to help avoid air entrapment in the implant reservoir.	Figure 10: Administer ranibizumab into the implant Figure 11: Dome of drug solution forms at tip of implant as viewed under magnification
Note:	When filling the ocular implant, drug solution should only exit the ocular implant from the release control element. If drug solution is leaking from the implant at a different location, such as the side of the implant, do not use the ocular implant. If fluid is leaking from the septum at the needle insertion site, the needle may not be fully penetrating the implant septum. Fully push the syringe forward before continuing to fill the ocular implant.
Continue filling the ocular implant until the implant is completely full of drug solution and all air has been expelled as evidenced by a dome of drug solution formed at the tip of the implant on the release control element (see Figure 11).
Step 9: Inspect the Filled Ocular Implant Under the Microscope Inspect the ocular implant under the microscope to ensure that the ocular implant is completely full of drug solution (see Figure 12).	Figure 12: Proper appearance of implant after initial filling with ranibizumab
Note:	Minimize air bubbles within the implant reservoir as they may cause slower drug release. If an air bubble is present, it must be no larger than 1/3 of the widest diameter of the implant. If excess air is observed, do not use the ocular implant.
Note:	No more than 30 minutes should pass between the initial fill of the implant and the insertion into the patient's eye to ensure that the release control element remains saturated with SUSVIMO (ranibizumab injection). If SUSVIMO (ranibizumab injection) dries in the release control element, the implant may not release the drug properly into the vitreous after insertion.
Step 10: Remove the Syringe and Guide Sleeve from the Carrier Remove the syringe and guide sleeve from the carrier by pulling back on the syringe (see Figure 13). The syringe will be locked into the guide sleeve. Properly dispose of the used syringe together with the needle and guide sleeve in a sharps disposal container or in accordance with local requirements.	Figure 13: Remove the syringe and guide sleeve from the insertion tool carrier
Step 11: Slide the Insertion Tool Handle into the Carrier Slide the insertion tool handle into the guide channel of the carrier, ensuring that both components are facing upwards (see Figure 14). Push the handle forward as far as it will go into the gripper tips (see Figure 15).	Figure 14: Insert the handle into the insertion tool carrier Figure 15: Fully inserted handle
Note:	Do not withdraw the handle and implant until the eye is ready for insertion. Contact between the implant and any surface or object – even within the sterile field – may result in the introduction of a foreign body into the vitreous.

Side Effects of Susvimo

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in one clinical trial of a drug cannot be directly compared with rates in the clinical trials of the same or another drug and may not reflect the rates observed in practice. The data below ( Table 2 ) reflect exposure of 248 patients with AMD in the Archway study through Week 40, 320 patients with DME in the Pagoda study up to Week 64, and 105 patients with DR in the Pavillion study through Week 52 following the SUSVIMO initial fill and implant insertion, refill, and implant removal (if necessary) procedures. In clinical trials of SUSVIMO in AMD patients, the most common (≥ 10%) adverse reactions up to Week 40 were conjunctival hemorrhage (72%), conjunctival hyperemia (26%), iritis (23%), and eye pain (10%). Septum dislodgement was reported in 0.4% of the AMD patient population.

In clinical trials of SUSVIMO in DME patients, patient population the most common (≥ 10%) adverse reactions up to Week 64 were conjunctival hemorrhage (62%), conjunctival hyperemia (15%), iritis (14%), eye pain (13%), cataract (11%), conjunctival disorder (10%) and vitreous hemorrhage (10%). In clinical trials of SUSVIMO in DR patients, the most common (≥ 10%) adverse reactions up to Week 52 were conjunctival hemorrhage (73%), conjunctival disorder (14%), iritis (12%) and conjunctival hyperemia (11%). Table 2 Adverse Reactions occurring in ≥ 4% of patients in the SUSVIMO arm Adverse Reactions AMD Week 40 DME Week 64 DR Week 52 SUSVIMO n = 248 Intravitreal ranibizumab n = 167 SUSVIMO n = 320 Intravitreal ranibizumab 0.5 mg n = 314 SUSVIMO n = 105 Conjunctival hemorrhage 72% 6% 62% 18% 73% Conjunctival hyperemia 26% 2% 15% 0 11% Iritis Iritis includes: iritis, anterior chamber flare, anterior chamber inflammation, and anterior chamber cell. 23% 0.6% 14% 2% 12% Eye pain 10% 5% 13% 6% 9% Conjunctival disorder Conjunctival disorder includes: conjunctival adhesion, conjunctival disorder, conjunctival edema, conjunctival erosion, conjunctival retraction, and subconjunctival fibrosis. 9% 0 10% 0.3% 14% Vitreous floaters 9% 2% 4% 5% 2% Conjunctival bleb/ filtering bleb leak Conjunctival bleb/filtering bleb leak includes: conjunctival bleb, conjunctival filtering bleb leak, conjunctival cyst, subconjunctival cyst, and implant site cyst. 8% 0 8% 0 2% Foreign body sensation in eyes 7% 1% 3% 2% 9% Headache Headache includes: headache and procedural headache. 6% 2% 6% 4% 9% Hypotony of eye 6% 0 3% 0 0 Vitreous detachment 6% 5% 8% 5% 9% Vitreous hemorrhage 5% 2% 10% 2% 6% Cataract Cataract includes: cataract, cortical cataract, nuclear cataract, and subcapsular cataract. 4% 4% 11% 7% 7% Corneal disorder 4% 0 1% 0 1% Corneal abrasion Corneal abrasion includes: corneal abrasion and vital dye staining cornea present. 4% 0.6% 4% 1% 4% Corneal edema 4% 0 4% 0.3% 4% In clinical trials of SUSVIMO, hyphema was reported in 0.4% of AMD patients, 1.9% of DME patients, and 1.9% of DR patients.

Warnings & Cautions for Susvimo

Endophthalmitis

In the active comparator period of controlled clinical trials in AMD, the ranibizumab implant has been associated with a 3-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab (1.7% in the SUSVIMO arm vs 0.5% in the intravitreal arm). When including extension phases of clinical trials, 2% (11/555) of patients receiving the ranibizumab implant experienced an episode of endophthalmitis. Reports occurred between days 5 and 853, with a median of 173 days. Many, but not all, of the cases of endophthalmitis reported a preceding or concurrent conjunctival retraction or erosion event.

In the active comparator period of the controlled clinical trial in DME, 0% of patients in the SUSVIMO arm compared to 0.3% in the intravitreal arm experienced an episode of endophthalmitis. When including the extension phase of the clinical trial, 0.7% (4/556) of patients receiving the ranibizumab implant experienced an episode of endophthalmitis. Reports occurred between days 625 and 1016, with a median of 824 days.

In the period with an observational comparator arm of the clinical trial in DR, there were no patients (0/105) in the SUSVIMO arm who experienced an episode of endophthalmitis . When including the extension phase of the clinical trial 0.8% (1/128) patients receiving the ranibizumab implant experienced an episode of endophthalmitis, with the event reported on day 695. Endophthalmitis should be treated promptly in an effort to reduce the risk of vision loss and maximize recovery. The SUSVIMO (ranibizumab injection) dose (refill-exchange) should be delayed until resolution of endophthalmitis . Patients should not have an active or suspected ocular or periocular infection or severe systemic infection at the time of any SUSVIMO implant or refill procedure. Appropriate intraoperative handling followed by secure closure of the conjunctiva and Tenon's capsule, and early detection and surgical repair of conjunctival erosions or retractions and strict/controlled aseptic technique conditions throughout refill-exchange procedures may reduce the risk of endophthalmitis .

Rhegmatogenous Retinal Detachment Rhegmatogenous retinal detachments have occurred in clinical trials of

SUSVIMO and may result in vision loss. Rhegmatogenous retinal detachments should be promptly treated with an intervention (e.g., pneumatic retinopexy, vitrectomy, or laser photocoagulation). SUSVIMO (ranibizumab injection) dose (refill-exchange) should be delayed in the presence of a retinal detachment or retinal break . Careful evaluation of the retinal periphery is recommended to be performed, and any suspected areas of abnormal vitreo-retinal adhesion or retinal breaks should be treated before inserting the implant in the eye.

Implant Dislocation

In clinical trials, the device has dislocated/subluxated into the vitreous cavity or has extended outside the vitreous cavity into or beyond the subconjunctival space. Device dislocation requires urgent surgical intervention. Strict adherence to the scleral incision length and appropriate targeting of the pars plana during laser ablation may reduce the risk of implant dislocation.

Septum Dislodgement

In clinical trials, a type of implant damage where the septum has dislodged into the implant body has been reported. Perform a dilated slit lamp exam and/or dilated indirect ophthalmoscopy to inspect the implant in the vitreous cavity through the pupil prior to and after the refill-exchange procedure to identify if septum dislodgement has occurred. Discontinue treatment with SUSVIMO (ranibizumab injection) following septum dislodgement and consider implant removal should the benefit of the removal procedure outweigh the risk.

The benefits and risks of retaining, removing, or removing and replacing an implant with a dislodged septum are not well characterized. Appropriate handling and insertion of the refill needle into the septum (avoid twisting and/or rotation) is required to minimize the risk of septum dislodgement.

Vitreous Hemorrhage Vitreous hemorrhages may result in temporary vision loss. Vitrectomy may

be needed in the case of a non-clearing vitreous hemorrhage . In clinical trials of SUSVIMO including the extension phases in patients with AMD, vitreous hemorrhages were reported in 5.2% (23/443) of patients receiving SUSVIMO. In the clinical trial of SUSVIMO including the extension phases in patients with DME, vitreous hemorrhages were reported in 10.1% (56/556) of patients receiving SUSVIMO. In the clinical trial of SUSVIMO including the extension phase in patients with DR, vitreous hemorrhages were reported in 9.4% (12/128) of patients receiving SUSVIMO. The majority of these hemorrhages occurred within the first post-operative month following surgical implantation and the majority of vitreous hemorrhages resolved spontaneously. Patients on antithrombotic medication (e.g., oral anticoagulants, aspirin, nonsteroidal anti-inflammatory drugs) may be at increased risk of vitreous hemorrhage. Antithrombotic medications are recommended to be temporarily interrupted prior to the implant insertion procedure.

The SUSVIMO (ranibizumab injection) dose (refill-exchange) should be delayed in the event of sight-threatening vitreous hemorrhage. The use of pars plana laser ablation and scleral cauterization should be performed to reduce the risk of vitreous hemorrhage.

Conjunctival Erosion or Retraction

A conjunctival erosion is a full thickness degradation or breakdown of the conjunctiva in the area of the implant flange. A conjunctival retraction is a recession or opening of the limbal and/or radial peritomy. Conjunctival erosions or retractions have been associated with an increased risk of endophthalmitis, especially if the implant becomes exposed.

Surgical intervention (e.g., conjunctival/Tenon's capsule repair) is recommended to be performed in case of conjunctival erosion or retraction with or without exposure of the implant flange. In clinical trials of SUSVIMO including the extension phases in patients with AMD, 3.6% (16/443) of patients receiving SUSVIMO reported conjunctival erosion and 1.6% (7/443) of patients receiving SUSVIMO reported conjunctival retraction in the study eye. In the clinical trial of SUSVIMO including the extension phases of patients with DME, 2.2% (12/556) of patients receiving SUSVIMO reported conjunctival erosion and 1.3% (7/556) of patients receiving SUSVIMO reported conjunctival retraction in the study eye.

In the clinical trial of SUSVIMO including the extension phase in patients with DR, 2.3% (3/128) of patients receiving SUSVIMO reported conjunctival erosion and 1.6% (2/128) of patients receiving SUSVIMO reported conjunctival retraction in the study eye. Appropriate intraoperative handling of conjunctiva and Tenon's capsule to preserve tissue integrity and secure closure of peritomy while ensuring placement of sutures away from implant edge may reduce the risk of conjunctival erosion or retraction. The implant and the tissue overlying the implant flange should be monitored routinely following the implant insertion.

Conjunctival Bleb

A conjunctival bleb is an encapsulated elevation of the conjunctiva above the implant flange, which may be secondary to subconjunctival thickening or fluid. Conjunctival blebs may require surgical management to avoid further complications, especially if the implant septum is no longer identifiable due to the conjunctival bleb. In clinical trials of SUSVIMO including the extension phases in patients with AMD, 5.9% (26/443) of patients receiving SUSVIMO reported conjunctival bleb/conjunctival filtering bleb leak in the study eye.

In the clinical trial of SUSVIMO including the extension phases in patients with DME, 9% (50/556) of patients receiving SUSVIMO reported conjunctival bleb/conjunctival filtering bleb leak in the study eye. In the clinical trial of SUSVIMO including the extension phase in patients with DR, 3.9% (5/128) of patients receiving SUSVIMO reported conjunctival bleb/conjunctival filtering bleb leak in the study eye. Strict adherence to the scleral incision length, appropriate intraoperative handling of conjunctiva and Tenon's capsule to preserve tissue integrity and secure closure of peritomy, and proper seating of the refill needle during refill-exchange procedures may reduce the risk of conjunctival bleb.

Postoperative Decrease in Visual Acuity Visual acuity was decreased by 4 letters

on average in the first postoperative month and 2 letters on average in the second postoperative month following initial implantation of SUSVIMO in patients with AMD . Visual acuity was decreased by 7 letters on average in the first postoperative month and 3 to 4 letters on average in the second postoperative month following initial implantation of SUSVIMO in patients with DME and DR .

Postoperative Intraocular Inflammation Postoperative intraocular inflammation has occurred following

SUSVIMO implantation. The majority of cases occurred during the first week following implantation and resolved within the first month. 5.10 Air Bubbles Causing Improper Filling of the Implant Minimize air bubbles within the implant reservoir as they may cause slower drug release. During the initial fill procedure, if an air bubble is present, it must be no larger than 1/3 of the widest diameter of the implant.

If excess air is observed after initial fill, do not use the implant. During the refill-exchange procedure, if excess air is present in the syringe and needle do not use the syringe and needle. If excess air bubbles are observed after the refill-exchange procedure, consider repeating the refill-exchange procedure. 5.11 Deflection or Movement of the Implant Use caution when performing ophthalmic procedures (e.g., B-scan ophthalmic ultrasound, scleral depression, or gonioscopy) that may cause deflection or movement of the implant and subsequent injury.

Pregnancy Safety for Susvimo

Pregnancy Risk Summary There are no adequate and well-controlled studies of SUSVIMO (ranibizumab injection) administration in pregnant women. Administration of ranibizumab to pregnant monkeys throughout the period of organogenesis resulted in a low incidence of skeletal abnormalities at intravitreal doses up to 41 times the human exposure (based on serum levels following the recommended clinical dose). No skeletal abnormalities were observed at serum trough levels similar to the human exposure after a single eye treatment at the recommended clinical dose ( see Data ). Animal reproduction studies are not always predictive of human response, and it is not known whether ranibizumab can cause fetal harm when administered to a pregnant woman. Based on the anti-VEGF mechanism of action for ranibizumab , treatment with SUSVIMO (ranibizumab injection) may pose a risk to human embryofetal development.

All pregnancies have a background risk of birth defects, loss, and other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects is 2% – 4% and of miscarriage is 15% – 20% of clinically recognized pregnancies.

Data Animal Data An embryo-fetal developmental toxicity study was performed on pregnant cynomolgus monkeys. Pregnant animals received intravitreal injections of ranibizumab every 14 days starting on Day 20 of gestation, until Day 62 at doses of 0, 0.125, and 1 mg/eye. Skeletal abnormalities including incomplete and/or irregular ossification of bones in the skull, vertebral column, and hindlimbs and shortened supernumerary ribs were seen at a low incidence in fetuses from animals treated with 1 mg/eye of ranibizumab.

The 1 mg/eye dose resulted in trough serum ranibizumab levels up to 41 times higher than observed human C max levels of SUSVIMO (ranibizumab injection) after treatment of a single eye. No skeletal abnormalities were seen at the lower dose of 0.125 mg/eye, a dose which resulted in trough exposures similar to single eye treatment with SUSVIMO (ranibizumab injection) in humans. No effect on the weight or structure of the placenta, maternal toxicity, or embryotoxicity was observed.

Pediatric Use of Susvimo

Pediatric Use The safety and efficacy of SUSVIMO (ranibizumab injection) in pediatric patients have not been established.

Contraindications for Susvimo

Ocular or Periocular Infections

SUSVIMO (ranibizumab injection) is contraindicated in patients with ocular or periocular infections.

Active Intraocular Inflammation

SUSVIMO (ranibizumab injection) is contraindicated in patients with active intraocular inflammation.

Hypersensitivity

SUSVIMO (ranibizumab injection) is contraindicated in patients with known hypersensitivity to ranibizumab products or any of the excipients in SUSVIMO (ranibizumab injection).

Clinical Studies of Susvimo

Neovascular (wet) Age-related Macular Degeneration (AMD)

The clinical efficacy and safety of SUSVIMO (ranibizumab injection) was assessed in a randomized, visual assessor-masked, active treatment-controlled study (Archway-NCT03677934) in patients with AMD. A total of 415 patients (248 in the SUSVIMO arm and 167 in the intravitreal ranibizumab arm) were enrolled and treated in this study. Patients were diagnosed with AMD within the 9 months prior to screening and received ≥ 3 doses of anti-VEGF intravitreal agents in the study eye within the last 6 months prior to screening. Each patient was required to have demonstrated a response to an anti-VEGF intravitreal agent prior to randomization.

Patients were randomized in a 3:2 ratio to receive continuous delivery of SUSVIMO (ranibizumab injection) via the SUSVIMO implant every 24 weeks or 0.5 mg intravitreal ranibizumab injections every 4 weeks. For patients randomized to the SUSVIMO arm, supplemental treatment with 0.5 mg intravitreal ranibizumab injections was available at Weeks 16, 20, 40, 44, 64, 68, 88, and 92, if needed. In the first 24 weeks, 1.6% of patients assessed for supplemental treatment received 1 or more supplemental treatment(s) and in the following 24 weeks, 5.4% of patients assessed for supplemental treatment received 1 or more supplemental treatment(s). The primary efficacy endpoint of change from baseline in distance Best Corrected Visual Acuity (BCVA) score averaged over Week 36 and Week 40 demonstrated that SUSVIMO was equivalent to intravitreal ranibizumab injections administered every 4 weeks.

Detailed efficacy results are shown in Table 3 and Figure 29 below. Table 3 Visual Acuity outcomes at Week 40 in Archway (GR40548) Study Outcome Measure BCVA measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart at a starting distance of 4 meters. SUSVIMO (100 mg/mL) n=248 Intravitreal ranibizumab 0.5 mg (10 mg/mL) n=167 Difference (95% CI) All estimates are adjusted estimates based on a mixed-effect model with repeated measures.

SUSVIMO arm - intravitreal ranibizumab arm. 95% is a rounding of 95.03% CI; The type 1 error was adjusted for interim safety monitoring. BCVA = Best corrected visual acuity Adjusted Mean change from baseline in BCVA score averaged over Weeks 36 and 40 0.2 0.5 -0.3 (-1.7, 1.1) Equivalence margins were ±4.5 letters. Q24W = every 24 weeks; Q4W = every 4 weeks Figure 29 Adjusted Mean change from Baseline in Best Corrected Visual Acuity in study eye through Week 48 in the Archway (GR40548) study Prior to study treatment, a median of 4 doses of anti-VEGF intravitreal agents were administered in the study eye of patients in the SUSVIMO and intravitreal ranibizumab arms., Decrease in BCVA at Week 4 during post-operative recovery period.

Consistent results were observed across patient subgroup analyses for mean change from baseline in BCVA score (age, gender, number of prior anti-VEGF intravitreal injections, and baseline BCVA score). Figure 29

Diabetic Macular Edema (DME)

The clinical efficacy and safety of SUSVIMO were assessed in a randomized, visual assessor-masked, active treatment-controlled study (Pagoda-NCT04108156) in patients with DME. A total of 634 patients (381 in the SUSVIMO arm and 253 in the intravitreal ranibizumab 0.5 mg arm) were enrolled and treated in this study. Patients were randomized in a 3:2 ratio to receive continuous delivery of SUSVIMO via the implant every 24 weeks or 0.5 mg intravitreal ranibizumab injections every 4 weeks. Prior to study treatment, a median of 4 doses of intravitreal ranibizumab 0.5 mg were administered in the study eye of patients in the SUSVIMO and intravitreal ranibizumab arms.

Patient ages ranged from 29 to 89 years with a mean of 60.7 years. A total of 21% of patients were previously treated for DME. At baseline, the overall mean visual acuity was 65.3 letters (range: 25 to 89 letters). The primary efficacy endpoint of change from baseline in distance Best Corrected Visual Acuity (BCVA) score averaged over Week 60 and Week 64 demonstrated that SUSVIMO was non-inferior to intravitreal ranibizumab injections administered every 4 weeks. Detailed efficacy results are shown in Table 4 and Figure 30 below.

Table 4 Key efficacy outcomes at Week 60 and Week 64 in the Pagoda (GR40550) Study Outcome Measure BCVA measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart at a starting distance of 4 meters. SUSVIMO 100 mg/mL n=381 Intravitreal ranibizumab 0.5 mg (10 mg/mL) n=253 Difference (95% CI) All estimates are adjusted estimates based on a mixed-effect model with repeated measures. 95% is a rounding of 95.05% CI; The type 1 error was adjusted for interim safety monitoring. BCVA = Best corrected visual acuity Change in BCVA scores from baseline averaged over Week 60 and Week 64 Adjusted Mean 9.6 9.4 0.2 (-1.2, 1.6) Figure 30 Adjusted Mean change from Baseline in Best Corrected Visual Acuity in study eye through Week 64 in the Pagoda (GR40550) study Consistent results were observed across patient subgroup analyses for mean change from baseline in BCVA score (age, ethnicity, gender, baseline HbA1c score, focal/macular laser history, baseline BCVA score, prior intravitreal anti-VEGF treatment and DR severity). Figure 30

Diabetic Retinopathy (DR)

The clinical efficacy and safety of SUSVIMO were assessed in a randomized, visual assessor and reading center-masked study (Pavilion-NCT04503551) in patients with moderately-severe to severe non-proliferative diabetic retinopathy (NPDR), without center-involved DME (CI-DME), and who had not received prior treatment in the study eye for DR. A total of 174 patients (106 in the SUSVIMO arm and 68 in the observational comparator arm) were enrolled in this study. Patients who had not received prior treatment in the study eye for DR were randomized in a 5:3 ratio to continuous delivery of SUSVIMO via the implant every 36 weeks or to clinical observation. Prior to the implant procedure, two loading doses of intravitreal ranibizumab 0.5 mg were administered in the study eye.

The observational comparator arm did not receive loading doses of intravitreal ranibizumab. For patients who developed CI-DME or proliferative diabetic retinopathy/anterior segment neovascularization in either arm, supplemental treatment with intravitreal injections of 0.5 mg ranibizumab was available per investigator's clinical judgment at any non-refill-exchange study visit. Patient ages ranged from 24 to 83 years with a mean of 53.9 years.

At baseline, the overall mean visual acuity was 82.4 letters (range: 69 to 97 letters). The primary efficacy endpoint was the proportion of patients with a ≥ 2-step improvement on the ETDRS-DRSS from baseline at Week 52 versus clinical observation. SUSVIMO with two loading doses of intravitreal ranibizumab was superior to clinical observation at Week 52. Detailed results are shown in Table 5 and Figure 31 below. Table 5 Efficacy Outcomes through Week 52 in the Pavilion (GR41675) Study Outcome Measure SUSVIMO 100 mg/mL (n=106) Clinical Observation (n=68) Difference 95% CI All estimates are adjusted estimates based on the CMH method. 95% is a rounding of 95.04% CI; the type 1 error was adjusted for interim safety monitoring. p<0.01 compared with clinical observation.

ETDRS-DRSS = Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Scores CMH = Cochran-Mantel-Haenszel test Adjusted proportion of patients with ≥ 2-step improvement from baseline on the ETDRS-DRSS at Week 52 80% 9% 71% (61%, 81%) Figure 31 Adjusted Proportion of Patients with a ≥ 2-Step Improvement from Baseline on ETDRS-DRSS in Study Eye over Time through Week 52 in the Pavilion (GR41675) Study In the SUSVIMO arm, none of the patients assessed for supplemental treatment received any supplemental injections of intravitreal ranibizumab and 40% of patients in the observational comparator arm received 1 or more supplemental treatments through Week 52. Consistent results were observed across patient subgroup analyses for ETDRS-DRSS score including age, race, ethnicity, baseline hemoglobin (HbA1c) and baseline ETDRS-DRSS score.

Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.

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