FDA decisions in eye care: A first-half 2026 recap

The first half of 2026 has delivered a notable mix of FDA approvals, complete response letters, and regulatory milestones across several therapeutic areas relevant to optometric practice. From first-in-class presbyopia drops and EDOF contact lenses to new tools for thyroid eye disease and ongoing setbacks in dry eye, the regulatory landscape has moved quickly. Below is a summary of the major decisions optometrists should be aware of heading into the second half of the year.

Approvals, CRLs, and BLA acceptance: Breaking down each decision

Deseyne EDOF daily contact lens: First-of-its-kind FDA clearance (January 13)

The US FDA cleared the Deseyne lens (Bruno Vision Care/Cataltheia Group), becoming the first daily disposable soft contact lens for presbyopia to utilize an Extended Depth of Focus (EDOF) optical design—technology previously limited to intraocular lenses.¹ The vifilcon C hydrogel lens features a patented hyperrefractive central zone and incorporates hyaluronic acid and tamarind seed polysaccharide to support sustained hydration. Clinical data supporting the clearance reported no adverse events, with visual acuity improving to 20/25 and 20/31 at intermediate and near distances, respectively.¹ The lens builds on more than a decade of clinical use in Europe under the Safilens brand. For ODs, Deseyne adds a presbyopia-specific contact lens option with a mechanism of action distinct from traditional multifocal designs.

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Yuvezzi approved as first dual-agent presbyopia drop (January 29)

The FDA approved Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution, 2.75%/0.1%; Tenpoint Therapeutics)—formerly known as Brimochol PF—marking the first and only dual-agent eye drop approved for presbyopia in adults.² Approval was supported by two phase 3 studies (BRIO-I and BRIO-II). In BRIO-II, the drop achieved all primary near vision endpoints, delivering a statistically significant improvement in binocular uncorrected near visual acuity of 3 lines or more over 8 hours without meaningful distance acuity loss. The 12-month BRIO-II study spanned more than 72,000 treatment days, making it the longest safety study conducted in presbyopia to date. Common side effects included headache, temporary eye pain, and impaired vision; ocular hyperemia rates were lower with Yuvezzi (2.8%) than with carbachol alone (10.7%). Commercial availability was expected in Q2 2026. This is a prescribable option for ODs managing presbyopic patients in states where topical pharmacologics are within scope.

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FDA issues CRL for idebenone in LHON (March 5)

Chiesi Global Rare Diseases announced that the FDA issued a complete response letter (CRL) for its new drug application for idebenone for the treatment of Leber hereditary optic neuropathy (LHON) in adolescents and adults.³ The application had received Priority Review with a PDUFA target date of February 28, 2026. The FDA stated it was unable to approve the application in its current form, citing the need for additional clinical data from adequate and well-controlled studies as well as clarification related to chemistry, manufacturing, and nonclinical information. The NDA was supported by data from the phase 3 RHODOS trial and the phase 4 LEROS open-label study. Idebenone is already approved internationally as Raxone in the EU, UK, and several other countries. LHON currently has no FDA-approved treatment in the US; ODs who identify patients with sudden, painless central vision loss should continue to refer urgently for genetic testing and specialist evaluation.

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TECNIS PureSee EDOF IOL approved for cataract surgery (March 12)

Johnson & Johnson announced FDA approval of the TECNIS PureSee intraocular lens (IOL), an EDOF IOL indicated for use in cataract surgery.⁴ According to the company, the lens is the first and only FDA-approved EDOF IOL without a warning regarding loss of contrast sensitivity, maintaining contrast sensitivity comparable to an aspheric monofocal IOL while providing an extended range of vision. The company reported 97% of patients experienced no very bothersome visual disturbances. Built on the TECNIS platform, PureSee is intended to address both cataract-related vision loss and the effects of presbyopia. US availability was anticipated later in 2026. For optometrists co-managing cataract surgery patients, PureSee expands the surgical IOL portfolio available at their surgical referral partners.

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Aldeyra receives third CRL for reproxalap in dry eye disease (March 17)

Aldeyra Therapeutics received its third CRL from the FDA for its NDA for reproxalap for the treatment of dry eye disease signs and symptoms.⁵ The FDA cited a lack of substantial evidence from adequate and well-controlled investigations and noted inconsistency of study results raises concerns about the reliability of positive findings, concluding the totality of evidence does not support effectiveness. Prior CRLs were issued in November 2023 and April 2025. The most recent NDA—submitted in June 2025 and accepted for review in July 2025—included data from a dry eye chamber trial, which met its primary ocular discomfort endpoint, but a field trial missed statistical significance for the primary end point. The FDA did not recommend additional trials following this latest CRL. Aldeyra intends to request a Type A meeting with the FDA to determine a path forward and has stated no current intention to conduct additional clinical trials. Reproxalap remains unapproved; ODs managing dry eye patients should continue current evidence-based treatment approaches.

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Outlook Therapeutics' BLA for ONS-5010 (Lytenava) accepted for review (June 24)

Following a successful appeal of a December 2025 CRL, Outlook Therapeutics resubmitted its biologics license application for bevacizumab-vikg (ONS-5010; Lytenava) for the treatment of neovascular age-related macular degeneration (nAMD), and the FDA accepted the resubmission for review with a PDUFA target action date of July 29, 2026.⁶ The Office of New Drugs determined in a Formal Dispute Resolution that data from the NORSE TWO phase 3 pivotal trial (NCT03834753)—together with confirmatory NORSE EIGHT natural history data and pharmacodynamic evidence—collectively established substantial evidence of effectiveness. This marks the fourth BLA cycle for Lytenava since 2022. If approved, Lytenava would be one of the first FDA-approved ophthalmic formulation of bevacizumab for wet AMD. ODs managing patients with nAMD should watch for a regulatory decision expected by late July 2026.

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Lumvoa approved for active and chronic thyroid eye disease (June 27)

The FDA approved veligrotug-vvze (Lumvoa; Viridian Therapeutics) for the treatment of thyroid eye disease (TED) regardless of disease activity or duration, making it the first IGF-1R inhibitor with labeling covering both active and chronic TED.⁷ Approval was supported by two phase 3 trials, THRIVE (active TED) and THRIVE-2 (chronic TED), both of which met primary and all secondary end points at week 15. Patients received five IV infusions every 3 weeks over 12 weeks; proptosis reductions were observed as early as week 3. The drug received both Priority Review and Breakthrough Therapy Designation. Key safety signals include hearing impairment (potentially permanent), hyperglycemia (12%), and infusion reactions (~9%). ODs involved in the detection and comanagement of TED may consider to be aware of this option and familiarize themselves with pre-treatment audiologic baseline assessments recommended in the labeling.

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References:

1. FDA clears first extended depth of focus contact lens for presbyopia. News release. Bruno Vision Care. December 23, 2025. Accessed January 12, 2026. https://www.businesswire.com/news/home/20251222625759/en/FDA-Clears-First-Extended-Depth-of-Focus-Contact-Lens-for-Presbyopia

2. Tenpoint Therapeutics Ltd. announces FDA approval of Yuvezzi, the first and only combination eye drop approved to treat presbyopia. News release. Tenpoint Therapeutics. January 29, 2026. Accessed January 29, 2026. https://tenpointtherapeutics.com/wp-content/uploads/2026/01/Tenpoint-Therapeutics-Receives-US-FDA-Approval-YUVEZZI_Final_1_28_26.pdf

3. FDA issues a Complete Response Letter (CRL) regarding the NDA for Idebenone for Leber hereditary optic neuropathy (LHON) in the United States. News release. Chiesi Global Rare Diseases. March 5, 2026. Accessed March 17, 2026. https://chiesirarediseases.com/media/20260305-fda-issues-a-complete-response-letter-crl-regarding-the-nda-for-idebenone-for-leber-hereditary-optic-neuropathy-lhon

4. Johnson & Johnson announces FDA approval of TECNIS PureSee intraocular lens. News release. Johnson & Johnson. March 12, 2026. Accessed March 12, 2026. https://www.jnj.com/media-center/press-releases/johnson-johnson-announces-fda-approval-of-tecnis-puresee-intraocular-lens-a-breakthrough-solution-for-u-s-cataract-patients

5. Aldeyra Therapeutics receives complete response letter from the US Food and Drug Administration for the reproxalap new drug application for the treatment of signs and symptoms of dry eye disease. Published March 17, 2026. Accessed March 17, 2026. https://ir.aldeyra.com/news-releases/news-release-details/aldeyra-therapeutics-receives-complete-response-letter-us-food-1

6. Outlook Therapeutics announces FDA acceptance of resubmitted Biologics License Application for ONS-5010/Lytenava (bevacizumab-vikg) as a treatment for wet AMD. Published June 16, 2026. Accessed June 17, 2026. https://www.globenewswire.com/news-release/2026/06/16/3312535/0/en/outlook-therapeutics-announces-fda-acceptance-of-resubmitted-biologics-license-application-for-ons-5010-lytenava-bevacizumab-vikg-as-a-treatment-for-wet-amd.html

7. Viridian Therapeutics announces US FDA approval and launch of Lumvoa (veligrotug-vvze) for the treatment of thyroid eye disease. News release. Viridian Therapeutics, Inc. June 26, 2026. Accessed June 27, 2026. https://www.businesswire.com/news/home/20260625016249/en/Viridian-Therapeutics-Announces-U.S.-FDA-Approval-and-Launch-of-Lumvoa-veligrotug-vvze-for-the-Treatment-of-Thyroid-Eye-Disease