Eylea HD 8mg offers wet AMD, DME and DR patients the option of a treatment requiring fewer injections than the previous 2mg formulation. Photo: Regeneron. Click image to enlarge.
Anti-VEGF therapy revolutionized the treatment of many intractable retinal problems, but burdened patients and practices with a busy schedule of office visits for injections, typically administered monthly. When Eylea launched over a decade ago at a 2mg dose, the drug was able to push the maintenance interval to bimonthly in many cases. Now, a high-dose formulation approved last Friday by the FDA has the potential to extend that to 16 weeks in some clinical scenarios, according to manufacturer Regeneron. The positive results of two clinical trials, Photon and Pulsar, sparked the drug’s approval, demonstrating non-inferiority and clinically equivalent vision gains at 48 weeks with eight-, 12- and 16-week dosing regimens after the three initial monthly doses.
The new formulation, called Eylea HD, is approved to treat wet age-related macular degeneration (AMD), diabetic macular edema (DME) and diabetic retinopathy (DR). The recommended regimen for Eylea HD is monthly injections for the first three months followed by treatments every eight to 16 weeks in wet AMD and DME and every eight to 12 weeks for DR.
Though adverse reactions occurred in 3% or fewer patients treated with Eylea HD, Regeneron reports that these included cataract, conjunctival hemorrhage, increased intraocular pressure, ocular discomfort, eye pain or irritation, blurry vision, floaters, vitreous detachment, corneal epithelium defect and retinal hemorrhage.
For more information, go to www.regeneron.com.