10/28/2026
FDA approves new options for presbyopia, thyroid eye disease, and ocular redness
On October 15 and 16, the FDA approved three ophthalmic medications: phentolamine 0.75% (Ryzumvi) for presbyopia, satralizumab (Enspryng) for thyroid eye disease (TED), and apraclonidine 0.125% (Brytli), an over-the-counter eye drop for ocular redness.
Key clinical insights ⬇️
🔹 Ryzumvi: An alpha-adrenergic antagonist that reduces pupil size without acting on the ciliary muscle. It is preservative-free.
🔹 VEGA-3 (n = 545): On day 8, 27.2% of patients gained ≥15 letters in near visual acuity, compared with 11.5% in the placebo group. The most common adverse events were ocular redness (21%) and irritation (16%), with no serious treatment-related events reported.
🔹 Enspryng: The first IL-6 receptor inhibitor for TED. In the SatraGO-2 trial (active TED), proptosis response was achieved in 52.9% of patients, compared with 23.4% in the placebo group. SatraGO-1 did not meet its primary endpoint.
🔹 Clinical practice: Enspryng is administered subcutaneously, with maintenance doses given at home every 4 weeks. It is contraindicated in patients with active hepatitis B and active or untreated latent tuberculosis.
These new mechanisms expand topical and at-home treatment options. In TED, a new drug class offers additional possibilities, while requiring careful patient selection.
⚠️ These are FDA approvals in the United States. Ryzumvi and Enspryng were evaluated in Phase 3 clinical trials.
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