One day, three approvals: FDA expands options for ocular redness, thyroid eye disease, and presbyopia

October 16, 2026, delivered 3 ophthalmic FDA approvals that, taken together, touch nearly every corner of the eye care practice, from the patient browsing a pharmacy aisle to the oculoplastic surgeon managing a rare autoimmune orbitopathy.

The first was a consumer product. The FDA approved Brytly, Alcon's apraclonidine ophthalmic solution 0.125%, for relief of eye redness due to minor irritations, describing it as the first nonprescription eye drop with apraclonidine.¹ The agency framed the decision as part of a broader push to expand access to nonprescription medicines.¹

The second was a first-in-class biologic for a rare disease. Roche announced that the FDA approved Enspryng (satralizumab) for adults with thyroid eye disease (TED), giving patients a subcutaneous therapy that can be self-administered at home after training.² The supplemental Biologics License Application had carried priority review with an October 15 PDUFA target date, as Ophthalmology Times reported in June.³

The third was a label expansion. Opus Genetics announced FDA approval of its supplemental New Drug Application for phentolamine ophthalmic solution 0.75% to treat presbyopia in adults.⁴ The drug is already marketed by Viatris as Ryzumvi for pharmacologically induced mydriasis.⁴

The 3 approvals share a common thread: each repurposes or extends a known molecule. Apraclonidine has long been prescribed at higher concentrations to control intraocular pressure; satralizumab has been approved for neuromyelitis optica spectrum disorder (NMOSD) since 2020; and phentolamine had already reached the clinic for reversing dilation.^1,2,4 What changes now is who can use them, and for what.

Brytly (apraclonidine ophthalmic solution 0.125%): An OTC whitening drop

Approval date: October 16, 2026¹

Brytly is approved as a nonprescription treatment for eye redness due to minor irritations in adults and children aged 12 years and older.¹ Alcon states that each dose whitens the eye for up to 12 hours, as Ophthalmology Times reported.⁵

The FDA noted that redness most often stems from swollen or dilated surface vessels, triggered by minor irritants such as dryness or dust.¹ Apraclonidine itself is not new to ophthalmology: higher-concentration prescription formulations are used to lower intraocular pressure in glaucoma and around certain laser procedures.¹ Brytly's 0.125% concentration is labeled for redness relief only.⁵

"Expanding access to safe and effective nonprescription treatments is a priority for FDA," said Mike Davis, MD, PhD, director of the FDA Center for Drug Evaluation and Research.¹

Labeling and counseling points

The Drug Facts label carries several instructions that clinicians may need to reinforce:¹

• Do not use more than twice daily.
• Remove contact lenses before instillation and wait at least 10 minutes before reinserting.
• Wait 5 minutes between Brytly and any other eye drop.
• Stop use and see a doctor for eye pain, vision changes, continued redness or irritation, or symptoms that worsen or last beyond 3 days.

Alcon reports that the formulation contains no bleaches or dyes and cites internal data showing a low risk of rebound redness and tachyphylaxis when used as directed; the company did not release clinical trial results with the announcement.⁵

Brytly enters a category in which low-dose brimonidine 0.025% has been the main alpha-agonist alternative to older vasoconstrictor whiteners. Selina McGee, OD, FAAO, DipABO, founder of Bespoke Vision, told Ophthalmology Times that the drop gives eye care professionals an option to recommend with long-lasting redness reduction from a single dose.⁵

Enspryng (satralizumab): A subcutaneous, at-home option for TED

Approval date: Announced October 16, 2026 (PDUFA target date October 15, 2026)^2,3

Enspryng is now approved for adults with TED, making it the first IL-6 receptor inhibitor and the first subcutaneous therapy approved in the indication.^2,6 After training from a health care provider, patients or caregivers can administer it at home, with dosing every 4 weeks during the maintenance phase.² TED marks the drug's second US indication after NMOSD.²

Satralizumab, developed by Chugai, is a humanized monoclonal antibody that binds both soluble and membrane-bound IL-6 receptors. Its recycling-antibody design allows pH-dependent, repeated target engagement and extended circulation.²

The SatraGO program

The approval rests on 2 identically designed phase 3 trials, SatraGO-1 (NCT05987423) and SatraGO-2 (NCT06106828), which together randomized 258 patients from 19 countries 1:1 to satralizumab or placebo.² The primary end point was the proportion of patients with active, moderate-to-severe TED achieving at least a 2-mm reduction in proptosis in the study eye at week 24.²

The trials diverged. SatraGO-1 missed its primary end point, while SatraGO-2 met it:²

Roche reported consistent results in SatraGO-2's overall population, which included patients with chronic TED, and no new safety signals relative to the drug's NMOSD profile.²

Clinician perspectives

César A. Briceño, MD, a trial investigator at the Scheie Eye Institute, University of Pennsylvania, told Ophthalmology Times that the treatment effect was consistent across both trials and that the divergent statistics appeared to reflect differing placebo response rates.⁶ He acknowledged that the proptosis benefit is smaller than reported with IGF-1R antagonists but said the safety profile could make satralizumab valuable for patients with multiple comorbidities or those who are poor candidates for existing therapies.⁶

Raymond Douglas, MD, PhD, an oculoplastic surgeon in Beverly Hills, California, described IGF-1R therapy as the current yardstick but said IL-6 blockade appears well suited to the inflammatory component of the disease.⁶ Both clinicians highlighted the convenience of home dosing for patients who live far from infusion centers or struggle to drive because of diplopia. Douglas cautioned, however, that protocols for monitoring patients treated outside the infusion setting still need to be worked out.⁶

Ryzumvi (phentolamine ophthalmic solution 0.75%): A presbyopia indication

Approval date: October 16, 2026⁴

The FDA approved Opus Genetics' supplemental New Drug Application for phentolamine ophthalmic solution 0.75% to treat presbyopia in adults.⁴ The preservative-free drop is a nonselective alpha-1 and alpha-2 adrenergic antagonist that narrows the pupil by blocking the iris dilator without engaging the ciliary muscle.⁴ Viatris, through an affiliate, holds exclusive US commercialization rights.⁴

The molecule has a track record in clinic. Ophthalmology Times covered its initial approval in September 2023, when it was renamed from Nyxol and cleared for reversal of pharmacologically induced mydriasis on the basis of the MIRA trials.⁷ That indication covers adults and children 3 years and older.⁴

VEGA-2 and VEGA-3

Both phase 3 presbyopia trials met their primary and all key secondary efficacy end points, with no treatment-related serious adverse events.⁴ As Ophthalmology Times reported when topline results were released in June 2025, VEGA-3 (NCT06542497) randomized 545 participants 3:2 to phentolamine or placebo, dosed once daily in the evening, at 40 US sites.⁸

The primary end point also required less than a 5-letter loss in binocular best-corrected distance visual acuity. No tachyphylaxis was observed over 6 weeks.⁸

Safety and clinical positioning

In the presbyopia trials, the most common ocular adverse reactions were conjunctival hyperemia (21%) and instillation site irritation (16%).⁴ The label advises against use in active ocular inflammation such as iritis and asks contact lens wearers to wait 10 minutes after dosing before reinserting lenses.⁴ Opus did not disclose a launch date.⁹

In comments to Ophthalmology Times, Alice Epitropoulos, MD, FACS, described the drop as an adjunct and lifestyle option rather than a replacement for glasses or contact lenses, noting that its non-miotic, non-accommodative mechanism may appeal to some patients.⁹ John Hovanesian, MD, was more measured, observing that existing presbyopia drops have met limited enthusiasm because of modest efficacy and side effects. He added that phentolamine's tolerability in mydriasis reversal is a point in its favor.⁹

References

1. FDA approves new nonprescription eye drop for relief of eye redness. News release. US Food and Drug Administration. October 16, 2026. Accessed October 20, 2026. https://www.fda.gov/drugs/drug-alerts-and-statements/fda-approves-new-nonprescription-eye-drop-relief-eye-redness

2. FDA approves Roche's Enspryng, a first-in-class IL-6R inhibitor, as the first and only at-home subcutaneous treatment option for thyroid eye disease (TED). News release. Roche. October 16, 2026. Accessed October 20, 2026. https://www.roche.com/media/releases/med-cor-2026-10-16

3. Ophthalmology Times Staff. FDA grants priority review to satralizumab sBLA for thyroid eye disease. Ophthalmology Times. June 30, 2026. Accessed October 20, 2026. https://www.ophthalmologytimes.com/view/fda-grants-priority-review-satralizumab-sbla-thyroid-eye-disease

4. Opus Genetics announces FDA approval of phentolamine ophthalmic solution 0.75% for the treatment of presbyopia. News release. Opus Genetics, Inc. October 16, 2026. Accessed October 20, 2026. https://www.globenewswire.com/news-release/2026/10/16/3382714/0/en/opus-genetics-announces-fda-approval-of-phentolamine-ophthalmic-solution-0-75-for-the-treatment-of-presbyopia.html

5. Shiva A. FDA clears low-dose apraclonidine as OTC redness reliever. Ophthalmology Times. October 19, 2026. Accessed October 20, 2026. https://www.ophthalmologytimes.com/view/fda-clears-low-dose-apraclonidine-as-otc-redness-reliever

6. Charters L, Stevenson S, Harp MD. FDA approves subcutaneous Enspryng for TED. Ophthalmology Times. October 16, 2026. Accessed October 20, 2026. https://www.ophthalmologytimes.com/view/fda-approves-subcutaneous-enspryng-for-ted

7. Filkins K, Harp MD, Kaiser Maharjan E, et al. FDA approves RYZUMVI (phentolamine ophthalmic solution) for the treatment of pharmacologically-induced mydriasis. Ophthalmology Times. September 27, 2023. Accessed October 20, 2026. https://www.ophthalmologytimes.com/view/fda-approves-ryzumvi-phentolamine-ophthalmic-solution-for-the-treatment-of-pharmacologically-induced-mydriasis

8. Harp MD. Opus Genetics reports positive phase 3 results for phentolamine ophthalmic solution 0.75%. Ophthalmology Times. June 26, 2025. Accessed October 20, 2026. https://www.ophthalmologytimes.com/view/opus-genetics-reports-positive-phase-3-results-for-phentolamine-ophthalmic-solution-0-75-

9. Joy J, Charters L, Stevenson S. FDA approves phentolamine ophthalmic solution 0.75% (Ryzumvi) for presbyopia. Ophthalmology Times. October 16, 2026. Accessed October 20, 2026. https://www.ophthalmologytimes.com/view/fda-approves-phentolamine-ophthalmic-solution-0-75-ryzumvi-for-presbyopia