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What are the relative safety concerns and safety advantages of sustained-release steroid implants?
Exercise caution in using sustained-release steroids
 Steve Charles |
I am opposed to the use of sustained-release steroids for diabetic macular edema, retinal vein occlusion and age-related macular degeneration largely because of potential glaucoma complications, which are often irreversible. Everyone is a steroid responder to an extent. The frequently quoted 6% incidence of glaucoma applies only to topical 1% prednisolone acetate. The rate approaches 100% with Retisert (fluocinolone intravitreal implant, Bausch + Lomb) and 30% with triamcinolone.
Moreover, cataract formation occurs in essentially 100% of patients using sustained-release steroids if the follow-up period is long enough. Cataract surgery is not without risk and has approximately a 0.5% to 1% rate of retinal detachment and a 0.01% incidence of endophthalmitis.
Anti-VEGF monotherapy may be a safer option, as it is not associated with glaucoma or cataract, and has been shown to be highly effective for diabetic macular edema (in the RISE and RIDE studies and other analyses from the DRCR.net), retinal vein occlusion (in BRAVO and CRUISE) and choroidal neovascularization due to AMD or other diseases.
Furthermore, it is important to note that using one therapy at a time can produce the unintended consequence of increasing duration of macular edema, thereby producing poor visual outcomes because of structural damage. Using dated, so-called “gold standard” therapy followed by substantial delay and then “rescue therapy” with a more effective agent may produce poor outcomes. Many retinal specialists perform grid laser for diabetic macular edema, then use an intravitreal steroid and finally apply anti-VEGFs, and then they attribute poor visual outcomes to the addition of the latter therapy.
Steve Charles, MD, FACS, FICS, is a clinical professor of ophthalmology at the University of Tennessee and principal architect of the Alcon Accurus and Constellation systems. Disclosure: Dr. Charles has no relevant financial disclosures.
Sustained-release steroids are a safe, effective alternative treatment
 Carl D. Regillo |
Intraocular corticosteroids have been shown to be effective in reducing macular edema and improving visual outcomes in patients with retinal vein occlusions and diabetic retinopathy. The use of steroids via intravitreal injection for these retinal problems dates back more than 10 years. During most of this time, clinicians have used triamcinolone suspension in an off-label fashion and have been comfortable with the expected side effects of IOP elevation and cataract progression, both of which are readily manageable.
Newer sustained-release steroid devices are now, or will soon be, available. The biodegradable dexamethasone implant Ozurdex (Allergan) is an FDA-approved, commercially available device that delivers favorable steroid effects for 4 to 6 months and has a relatively low rate of IOP elevation. It is approved for macular edema related to retinal vein occlusion and is being tested for macular edema from diabetic retinopathy. It appears to have a better safety profile than the usual 4-mg dose of triamcinolone. A fluocinolone device, Iluvien (Alimera Sciences), has been tested for macular edema from both diabetic retinopathy and retinal vein occlusion and is under FDA consideration for the former indication. Its primary advantage is a long 2- to 3-year duration of effect. In phase 3 testing, its safety profile was comparable to that of triamcinolone in terms of IOP elevation, but rates of significant cataract development were high at 3 years. However, cataract surgery generally results in good outcomes, because the underlying retinal condition often responds favorably to steroid treatment.
Given the chronic nature of macular edema from retinal conditions, as well as the short duration of anti-VEGF drugs, sustained-release steroids represent a good treatment alternative with an acceptable safety profile. They are an important addition to our armamentarium, alongside laser and anti-VEGF therapy.
Carl D. Regillo, MD, FACS, is an OSN Retina/Vitreous Board Member and the director of clinical retina research at Wills Eye Institute and professor of ophthalmology at Thomas Jefferson University. Disclosure: Dr. Regillo is a consultant for and receives research support from Alimera and Allergan.