FDA advisers review SYD-101 atropine drops for childhood myopia; oral OCT-980 gets orphan status for rhodopsin retinitis pigmentosa

• FDA Oct 30, 2026
  FDA advisory committee reviews Sydnexis's SYD-101 low-dose atropine to slow myopia progression in children
  The Food and Drug Administration (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee met Oct. 30 to discuss the new drug application for SYD-101, atropine sulfate ophthalmic solution 0.01%, for slowing myopia progression in children 3 years of age or older. The FDA's 2025 complete response letter said the phase 3 STAR trial met its primary end point but the data did not support effectiveness, according to Ophthalmology Times. Healio reported that the FDA found results suggested limited to no clinical benefit; no vote was reported. No FDA-approved drug for pediatric progressive myopia exists in the U.S., according to Ophthalmology Times.
  Sources: FDA, Healio, Ophthalmology Times, Ophthalmology Times
• FDA Oct 27, 2026
  FDA grants orphan drug designation to Octant's oral OCT-980 for rhodopsin-associated retinitis pigmentosa
  Octant said Oct. 27 that the Food and Drug Administration (FDA) granted orphan drug designation to OCT-980, an oral small molecule designed to correct misfolded rhodopsin and restore its trafficking within photoreceptors, for rhodopsin-associated autosomal dominant retinitis pigmentosa. A phase 1b/2 open-label, multiple ascending dose study is enrolling adults aged 18 to 65 years at U.S. sites, who take oral tablets for up to 48 weeks. Octant has not reported clinical data. "People with RHO-adRP are living with progressive vision loss and no approved treatment options today," CEO Sri Kosuri said.
  Sources: Ophthalmology Times, Eyewire+, Pharmacally

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