Is Ozurdex (dexamethasone) 0.7mg intravitreal injection, once per 3 months, medically necessary for a patient with retinal neovascularization and Coats' Disease, who has previously received Avastin (bevacizumab), Eylea (aflibercept), and Vabysmo (faricimab) intravitreal injections?

Medical Necessity Assessment for Ozurdex in Coats' Disease

Ozurdex (dexamethasone 0.7mg intravitreal implant) is NOT medically necessary for this patient with Coats' Disease and retinal neovascularization, as there is insufficient evidence supporting its use in Coats' Disease, and existing data suggests potential harm from anti-VEGF agents in this condition—making the addition of corticosteroid therapy experimental rather than evidence-based.

Evidence-Based Treatment Standards for Coats' Disease

Primary Treatment Modality

• Laser photocoagulation and/or cryotherapy directed at abnormal telangiectatic vessels remains the standard of care for Coats' Disease 1, 2
• Direct ablation of vascular telangiectasia with large-spot-size diode laser has demonstrated resolution of exudative retinal detachment in 100% of treated cases 1

Anti-VEGF Use in Coats' Disease: Significant Safety Concerns

• Intravitreal bevacizumab (Avastin) in Coats' Disease has been associated with vitreoretinal fibrosis in 50% of cases and traction retinal detachment in 38% of cases 2
• These tractional complications developed at a mean of 5 months following anti-VEGF injections and are not typically observed with standard laser/cryotherapy alone 2
• The patient has already received multiple anti-VEGF agents (Avastin, Eylea, Vabysmo), which may have contributed to current complications rather than providing benefit 2

Ozurdex Evidence Specific to Coats' Disease

Limited and Low-Quality Evidence

• Only one case report exists documenting Ozurdex use in Coats' Disease, involving 2 pediatric patients who received it as an adjunct to other therapies 3
• This case report provides insufficient evidence to establish efficacy, safety, or medical necessity 3
• The report noted temporary IOP elevation in both cases, adding to known safety concerns 3

FDA-Approved Indications for Ozurdex

• Ozurdex received FDA approval in 2009 specifically for retinal vein occlusion, NOT for Coats' Disease or retinal neovascularization from other etiologies 4
• The GENEVA study demonstrated efficacy in retinal vein occlusion with visual gains at 90 days that were lost by 6 months 4
• Therapeutic effect diminishes between 3-6 months, requiring retreatment intervals of at least 4 months 4

Retinal Neovascularization Management

Evidence-Based Approach for Neovascularization

• For retinal neovascularization, dense peripheral panretinal photocoagulation (PRP) is the best treatment 5
• Anti-VEGF agents can be used adjunctively when complete PRP is insufficient to control angiogenesis, but this applies to retinal vein occlusion-related neovascularization, not Coats' Disease 5
• In diabetic retinopathy with retinal neovascularization, anti-VEGF agents (ranibizumab, aflibercept, bevacizumab) are effective, but corticosteroids are not first-line therapy 5

Corticosteroid Role in Neovascular Disease

• Intravitreal corticosteroids are considered second-line therapy for macular edema in retinal vein occlusion due to significant ocular side effects including secondary glaucoma (18-20% incidence) and cataract formation (10-16% at one year) 5, 4
• Corticosteroids have a role when there is failure to respond or inadequate response to anti-VEGF therapy in retinal vein occlusion 5
• The SCORE2 study showed dexamethasone rescue was used for poor responders to aflibercept in CRVO, not as primary therapy 5

Critical Safety Considerations

Known Ozurdex Complications

• IOP elevation requiring topical anti-glaucoma therapy occurs in 18-20% of patients 4
• Cataract formation/progression occurs in 10-16% at one year 4
• The patient already has pseudophakia and nuclear sclerosis history, indicating prior cataract issues 4
• Endophthalmitis, though rare, has been reported following Ozurdex implantation 6

Inappropriate Treatment Escalation

• The patient has received three different anti-VEGF agents (Avastin, Eylea, Vabysmo) without documented benefit, suggesting the underlying pathology is not VEGF-mediated or is refractory to this approach 1, 2
• Adding corticosteroid therapy when anti-VEGF therapy has failed in Coats' Disease lacks evidence-based rationale 3

Clinical Recommendation

The appropriate management strategy should focus on:

• Direct laser photocoagulation or cryotherapy to ablate abnormal telangiectatic vessels in Coats' Disease 1
• Panretinal photocoagulation for retinal neovascularization if present 5
• Discontinuation of anti-VEGF therapy given the risk of vitreoretinal fibrosis and traction in Coats' Disease 2
• Close monitoring for vitreoretinal traction given the patient's extensive anti-VEGF exposure history 2

Ozurdex every 3 months represents off-label, experimental use without supporting evidence in Coats' Disease and should not be authorized as medically necessary.