Sydnexis, Inc. announced new data from comprehensive subgroup analyses from the phase 3 study of atropine for the reduction of myopia progression (STAR) trial of SYD-101. The data were presented during an oral session at the 51st Annual Meeting of the American Association for Pediatric Ophthalmology and Strabismus (AAPOS) in Boston, the company said in a press release. 

The phase 3 STAR trial evaluated a broad population of 847 children aged 3 to 14 years at treatment initiation. Participants with myopia of -0.50 D to -6.00 D, with a mean baseline progression of -2.65 D, were enrolled across the United States and Europe and randomized (1:1:1) to vehicle (placebo) and SYD-101 0.01%. The study’s primary efficacy endpoint was the proportion of patients with confirmed progression of -0.75 D, and a key secondary endpoint was annual progression rate. SYD-101 0.01% successfully met both the primary endpoint (P<.001) and the key secondary endpoint. Additionally, SYD-101 was well tolerated with no unexpected atropine-related adverse events, according to the news release. 

Some of the key findings from the presentation showed SYD-101 0.01% significantly reduced myopia progression across all time points tested and met the primary efficacy endpoint at 36 months of confirmed myopia progression of -0.75 D or worse (vehicle vs 0.01%; P=.0226). Also, SYD-101 0.01% met the key secondary endpoint of mean annual progression rate (APR) at 12, 24, and 36 months. At month 36, the APR was -0.30 D per year for the 0.01% dose vs -0.38 D per year for vehicle (P<.001).

In addition, treatment benefit of SYD-101 0.01% was highest in younger children compared with older children. In children aged 3 to 12 years at treatment initiation, myopia progression was reduced by 47.9% at 12 months, 37.6% at 24 months, and 28.0% at 36 months vs vehicle ‑1.07 D; 0.01% -0.77 D (P=0.0002). Participants aged 13 to 14 years at treatment initiation showed minimal progression regardless of treatment.

Another key finding from the presentation was that treatment benefit was greatest in children exhibiting fast progression (>0.5 D year) and with mild to moderate baseline myopia (-0.50 D to -3.00 D). In this subgroup, SYD-101 0.01% reduced myopia progression by 76.3% at 12 months, 65.1% at 24 months, and 56.9% at 36 months vs vehicle -1.18 D; 0.01% -0.51 D (P=.0004). SYD-101 was well tolerated with no unexpected atropine-related adverse events, the company said.

SYD-101 is currently approved in the European Union and UK, where it is licensed to Santen S.A. and marketed as Ryjunea.