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Age Predicts Pterygium Progression in Phase 2 Analysis, With Olivia L. Lee, MD
Younger age and recurrent disease significantly increase the risk of pterygium progression, highlighting critical factors for ophthalmologists.
A post hoc analysis from a Phase 2 trial of CBT-001, a topical multikinase inhibitor, suggests that younger age and recurrent disease are key risk factors for pterygium progression.
The analysis, presented at the 2025 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting, found that among 48 patients evaluated, those younger than 52 years and those with a history of recurrence were more likely to show disease progression over six months.
"We want to inform ophthalmologists who see patients with pterygia what the risk factors for pterygium progression are," Olivia L. Lee, MD, a corneal diseases and uveitis specialist at UCI Health, told HCPLive. "There was a finding that the younger patients, less than 52 years of age, had a higher risk of progression, and the patients who had recurrent pterygia were at higher risk for progression."
Pterygium affects up to 15 million people in the US, but only 2.5 million have been diagnosed, and there is little evidence on the clinical characteristics correlated with pterygium progression. This post-hoc analysis measured data from a Phase 2 randomized clinical trial on the safety and efficacy of a topical multikinase inhibitor.
Lee and colleagues evaluated the link between disease characteristics at baseline from 48 patients (study arm, n = 25; placebo arm, n = 23) and through 6 months (placebo arm, n = 23). The team assessed baseline characteristics, including age, sex, pterygium type, duration of disease, symptoms, vascularity, and hyperemia using Spearman correlation coefficients (CC) for continuous variables and t-tests for dichotomous variables.
Upon analysis, pterygium length was associated with vascularity (CC, 0.64; P <0.001) and conjunctival hyperemia (CC, 0.473; P =0.001), but investigators found these factors did not predict pterygium progression (P =0.507 and P =0.160, respectively). Further progression occurred in patients younger than the median age (CC, –0.508; P =0.013) and those with recurrent pterygium (P =0.051).
Lee noted that patients with more hyperemia and more vascularity in the pterygia itself were associated with longer length, emphasizing the importance of monitoring these clinical features during assessment. Surgical intervention remains the primary treatment for pterygium, but managing recurrences remains a challenge.
"Those recurrent pterygia that, despite good surgical outcomes initially, tend to be more challenging to treat," Lee told HCPLive. "We're hoping that this drug, once it's approved, can be used for helping with these recurrent pterygia."
Lee indicated the Phase 3 trial of CBT-001 is underway, with one-year follow-up ongoing.
"The patients just finished enrolling, but we're still following those patients for one year," Lee told HCPLive. "We’re very hopeful that we'll get good results from the Phase 3, and we can, at future meetings, tell you the progress towards FDA approval."
Lee reports no relevant disclosures.
