INDICATIONS & USAGE DIABETIC MACULAR EDEMA : Treatment of macular edema in diabetic retinopathy. RETINAL VEIN OCCLUSION : Treatment of macular edema following branch or central retinal vein occlusion ( BRVO/CRVO ). POSTERIOR SEGMENT UVEITIS : Treatment of macular edema as a part of non-infectious uveitis affecting the posterior segment. POST CVA / MI PATIENTS : Treatment of DME / RVO cases irrespective of naïve / refractory status. PCME/PME : Pseudophakic CME Saturday, June 8, 2024 3
4 Landmarks in the treatment of DME
5 The MEAD trial – pivotal Phase 3 study in DME Patients were randomised 1:1:1 between: DEX implant 0.7 mg (n=351) DEX implant 0.35 mg* (n=347) Sham (n=350) Efficacy The percentage of patients with > 15 letter improvement in BCVA was 22.2% with Dex 0.7 mg, 18.4% with Dex o.35 mg and 12% with sham. The mean reduction in CRT was -111.6µm with Dex 0.7 mg, -107.9µm with Dex o.35 mg and -41.9µm with sham.
Early Vs Late Switch 9 Retrospective and single-center study in 69 eyes to compare 24-month results of early (n=31) vs late-switch (n=38) to OZURDEX in DME patients who had an insufficient response to anti-VEGF treatment. The primary endpoint was the difference in mean change in BCVA and in CST. BCVA (Improved from 0.2 to 0.4 in early switch group; no significant improvement in late group) CST (Reduction of >10% was noted in 71% vs 47.4% in the early & late switch groups respectively)
10 ACCENTRIX ACCENTRIX ACCENTRIX OZURDEX
Possible therapeutic approaches to a patient with DME 11 Start on anti-VEGF therapy Start on OZURDEX® Switch to OZURDEX® Continue on OZURDEX® Patient with DME requiring intravitreal therapy How do we know when to switch? Early or late? 3 or 6 injections? After how many injections? How to select the suitable subject for best efficacy and safety results? How long to continue and how will patients respond in real life? Switch to another anti-VEGF agent Continue on anti-VEGF Switch to another agent
RVOs with macular edema – The GENEVA Study N = 1267 : 3 arms – 0.7mg Dex (427); 0.35mg Dex (414); sham(426) Time to achieve a 15-letter improvement in BCVA was significantly less in both DEX implant groups compared with sham. The percentage of eyes with a > or =15-letter improvement in BCVA was significantly higher in both DEX implant groups compared with sham. Saturday, June 8, 2024 12
Case scenario 70 y/M, DM, HTN DV for 4 months in RE BCVA: RE- 3/60, N36; LE- 6/9, N6 BE- PCIOL RE- CRVO with CME BASELINE
2nd month BCVA 5/60, N24 After 1 st Injection of Injection Ranibizumab
3rd month BCVA 6/60, N24 After 2 nd Injection of Injection Ranibizumab
4th month BCVA 6/60, N24 After 3 rd Injection of Injection Ranibizumab
Multicenter retrospective cohort study. Eighty-two eyes (63 patients) receiving 142 implant injections over 35 months were included. The probability of visual acuity improvement (≥0.3 logmar ) was 39% at 1 month, 49% at 3 months, 52% at 6 months, and 58% at 12 months. Dexamethasone implant use in uveitis provides favorable visual acuity and vitreous haze score outcomes but requires repeated injections. Saturday, June 8, 2024 21
Saturday, June 8, 2024 22 INJ OZURDEX
Patients with recent CVA/MI Relative contra-indication to anti-VEGF agents DME BRVO with macular edema CRVO with macular edema Saturday, June 8, 2024 23
Cataract with co-existing DME Saturday, June 8, 2024 24
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DEXCAT Study Mean CSF thickness post- treatment was lower in the concomitant gp . than previous DEX gp . ( p < 0.001) Saturday, June 8, 2024 27
DEXCAT Study The CSF increased from 368±38 μm to 371 ± 52 μm in the pre-cataract DEX group While, in the concomitant treatments group, it decreased from 480±101 μm to 325±57 μm A reduction of CSF thickness of ≥ 20% was observed in 7.3% of eyes in the ‘pre-cataract DEX’ group and in 83.7% of eyes in the ‘concomitant treatments’ group at 3 months ( p < 0.001) Saturday, June 8, 2024 28
DEXCAT Study +13 letter gain with pre- cataract DEX group (after 3 months ). +18 letter gain was noted after 3 months i n the concomitant treatment group Saturday, June 8, 2024 29
PME (Pseudophakic Macular Edema) Pseudophakic Cystoid Macular Edema Diabetics with no apparent DR at time of Cataract Sx ( incresed risk of CME) Non-diabetics Intravitreal Dex Implant Edeme refractory to topical steroids & NSAIDs Saturday, June 8, 2024 30