FDA Advisory Committee to review SYD-101 for pediatric myopia October 30

The FDA will convene an Advisory Committee on October 30, 2026, to review the SYD-101 (atropine 0.01%; Sydnexis) application for pediatric progressive myopia (PPM), according to a new announcement from Sydnexis. The meeting will include an Open Public Hearing. SYD-101 is already approved in the European Union and United Kingdom, where it is licensed to Santen and marketed as Ryjunea.¹

The meeting follows a complete response letter (CRL) issued October 23, 2025, in which the FDA acknowledged the STAR trial met its primary endpoint but concluded the submitted data did not support effectiveness.² Sydnexis then filed a Formal Dispute Resolution Request with the FDA Office of Specialty Medicine, and in July 2026 the agency announced its intent to convene the committee.³ No FDA-approved pharmaceutical therapy for PPM exists in the US, so eye care providers prescribing atropine currently rely on compounded formulations.¹

The phase 3 STAR trial (NCT03918915) was a multicenter, randomized, double-masked, vehicle-controlled study of 847 children aged 3 to 14 years across the US and Europe.¹ Enrolled children had baseline myopia of −0.50 D to −6.00 D and were randomized 1:1:1 to vehicle or 1 of 2 SYD-101 concentrations.³

The prespecified primary end point was the proportion of children with confirmed myopia progression beyond −0.75 D at month 36. The 2003 FDA Dermatologic and Ophthalmic Drugs Advisory Committee identified this threshold as clinically meaningful, and the FDA later agreed to its use in STAR. SYD-101 0.01% met the primary end point versus vehicle (P = .0226).¹

The STAR trial

Annual myopia progression rate served as the key secondary endpoint, and SYD-101 0.01% also met this measure versus vehicle (P = .0002). The company reported the drop was well tolerated, with no new safety signals identified through month 48. Rates of specific adverse events, including photophobia or near-vision complaints, were not included in the announcement.¹

Subgroup analyses presented at the 2026 American Association for Pediatric Ophthalmology and Strabismus annual meeting showed treatment benefit across the study population. According to Sydnexis, the largest reductions occurred in children aged 3 to 12 years and in fast progressors.⁴

The Open Public Hearing portion of the October meeting will allow physicians and caregivers to share firsthand clinical experience directly with committee members. Sydnexis said it will release meeting logistics, including how to register to attend or submit comments, as details become available.¹ In July, the company said it had asked the FDA to include practicing pediatric ophthalmologists and optometrists in the discussion.³

"We welcome the opportunity for a thorough, science-based discussion on SYD-101 and the totality of evidence supporting its use in pediatric progressive myopia," said Perry Sternberg, chief executive officer of Sydnexis, in the announcement.¹

"Low-dose atropine is already used routinely by many pediatric ophthalmologists and optometrists as part of standard clinical practice," said Rahul Bhola, MD, chief of ophthalmology at Children's Hospital of Orange County.¹ "But an FDA-approved treatment would give physicians a standardized, rigorously evaluated option."

Bhola added an approved therapy "would also help address the access and consistency challenges often associated with compounded formulations, which is the only option available today in the US."¹

If approved, SYD-101 would give optometrists a standardized, FDA-reviewed atropine option in place of compounded preparations, with prescribing subject to state scope of practice. Until a decision, ODs managing progressing myopia in children continue to rely on compounded low-dose atropine alongside FDA-approved optical interventions. Optometrists interested in addressing the committee should watch for Open Public Hearing registration details from Sydnexis and the FDA.¹

References

1. Sydnexis announces FDA Advisory Committee meeting date to review NDA for SYD-101 for pediatric progressive myopia. News release. Sydnexis, Inc; September 24, 2026. Accessed September 24, 2026. https://sydnexis.com/sydnexis-announces-fda-advisory-committee-meeting-date-to-review-nda-for-syd-101-for-pediatric-progressive-myopia/

2. Sydnexis receives complete response letter from FDA for SYD-101 to slow pediatric myopia progression. News release. Sydnexis, Inc; October 23, 2025. Accessed September 24, 2026. https://www.businesswire.com/news/home/20251023759236/en/Sydnexis-Receives-Complete-Response-Letter-from-FDA-for-SYD-101-to-Slow-Pediatric-Myopia-Progression

3. Sydnexis announces FDA Advisory Committee meeting to review NDA for SYD-101 for pediatric progressive myopia. News release. Sydnexis, Inc; July 13, 2026. Accessed September 24, 2026. https://sydnexis.com/sydnexis-announces-fda-advisory-committee-meeting-to-review-nda-for-syd-101-for-pediatric-progressive-myopia/

4. Sydnexis announces new data from phase 3 STAR trial of SYD-101 presented at 2026 AAPOS Annual Meeting. News release. Sydnexis, Inc; March 2026. Accessed September 24, 2026. https://www.biospace.com/press-releases/sydnexis-announces-new-data-from-phase-3-star-trial-of-syd-101-presented-at-2026-aapos-annual-meeting