OT Roundup: 3 FDA approvals, vorolanib insert miss, brepocitinib in uveitis

This edition of OT Roundup covers 3 FDA approvals announced on a single day, a second phase 3 miss for Duravyu in wet age-related macular degeneration (AMD) discussed with Veeral Sheth, MD, positive phase 3 results for brepocitinib in noninfectious uveitis, and registry data on GLP-1 receptor agonists and anti-VEGF treatment in diabetic macular edema (DME).

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Three FDA approvals in one day

On October 16, the FDA approved the first nonprescription apraclonidine eye drop, Brytly (apraclonidine ophthalmic solution 0.125%; Alcon), for eye redness; the first at-home subcutaneous therapy for thyroid eye disease (TED), satralizumab (Enspryng; Roche); and a presbyopia indication for phentolamine ophthalmic solution 0.75% (Opus Genetics), already marketed as Ryzumvi (Viatris) to reverse pharmacologically induced mydriasis. In the phase 3 VEGA-3 trial, 27.2% of patients on phentolamine gained at least 15 letters of near vision 12 hours after the day 8 dose, vs 11.5% on placebo.

>>> Read the full roundup of the 3 approvals here.

Duravyu misses noninferiority in LUCIA

Duravyu (vorolanib insert; EyePoint), a sustained-release tyrosine kinase inhibitor, missed its primary end point in the Phase 3 LUCIA trial, the second of 2 pivotal wet AMD trials. Sheth, of University Retina, said insert eyes needed 38% fewer injections but gained fewer letters than aflibercept. “I definitely don't think that these results sink the class,” he said, and he suggested weighing who was enrolled, how rescue was defined and what happened to vision at 1 year. EyePoint will cut about 53% of its workforce and end both wet AMD trials early to focus on DME.

>>> Read the full LUCIA trial coverage here.

>>> Read about EyePoint's pivot to DME here.

Brepocitinib meets all phase 3 end points in noninfectious uveitis

In the 2 phase 3 CLARITY trials, which enrolled 371 patients, brepocitinib (Priovant Therapeutics), a first-in-class inhibitor of tyrosine kinase 2 and Janus kinase 1, met the primary end point of time to treatment failure. The hazard ratio was 0.27 in CLARITY-1 and 0.22 in CLARITY-2. Pooled steroid-free quiescence at week 48 was 62% vs 20% on placebo. Priovant plans to file a supplemental new drug application in the first half of 2027.

>>> Read the full brepocitinib story here.

GLP-1 receptor agonists and anti-VEGF burden in DME

An IRIS Registry analysis presented at the American Academy of Ophthalmology meeting matched 9,896 patients who started a GLP-1 receptor agonist with controls. Over 36 months, anti-VEGF injection trajectories, visual acuity and central subfield thickness did not differ significantly. The retrospective design shows association, not cause.

>>> Watch the full interview with Preeti Nagalamadaka, BS, here.

Where to listen

OT Roundup is part of the Eyepod podcast network.

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New episodes of OT Roundup will be available every other Friday.