Aflibercept injection a promising treatment for ROP in preterm infants

Intravitreal aflibercept therapy appears to be safe and efficacious in the management of retinopathy of prematurity (ROP) through 2 years of age when compared with laser therapy in children who are born preterm or with low birth weight, according to 2-year data from the nonrandomized FIREFLYE trial.

The present analysis included 100 children who were born very or extremely preterm (gestational age ≤32 weeks, median gestational age 26 weeks) or with very or extremely low birth weight (≤1,500 g). These children had been previously treated with a 0.4-mg injection of aflibercept (66 children, 128 eyes) or laser (34 children, 64 eyes).

Efficacy outcomes included ROP status, unfavourable structural outcomes, ROP recurrence, treatment for ROP complications, completion of vascularization, and visual function. Safety was also assessed in terms of adverse events and growth and neurodevelopmental outcomes.

At 2 years of age, ROP was not detected in 61 of 63 children in the aflibercept group and in 30 of 32 in the laser group (96.8 percent vs 93.8 percent). The proportion of those with no unfavourable structural outcomes was 93.9 percent versus 94.1 percent. None of the children experienced new retinal detachment.

Four children in the aflibercept group (6.1 percent) received treatment for ROP complications before 1 year of age. Most children were able to fix and follow a 5-cm toy (96.7 percent in the aflibercept group vs 98.4 percent in the laser group). High myopia occurred in nine eyes among five children in the aflibercept group and in 13 among nine children in the laser group.

There were no significant between-group differences observed in growth and neurodevelopmental outcomes as measured by Bayley Scales of Infant and Toddler Development and Adaptive Behavior Scales, respectively.