Summary

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• This summary is based on the review of two randomized controlled trial(s). ^[1-2]
• In the Dry Eye Disease (DED) Study, cenegermin b.i.d. showed a responder rate of 29.3% (24/82, P = 0.007), significantly higher than the vehicle group at 11.9% (10/84). Only the cenegermin t.i.d. group demonstrated statistically significant reductions in Symptom Assessment In Dry Eye (SANDE) scores (P value range, 0.002-0.008), although the primary endpoint change in Schirmer I score was not statistically significant.
• In the Neurotrophic Keratopathy Study, cenegermin-treated patients exhibited higher rates of corneal healing at week 8 compared to the vehicle group, with conventional assessment showing 69.6% healing in the cenegermin group versus 29.2% in the vehicle group (P = 0.006) and conservative assessment showing 65.2% versus 16.7% (P < 0.001), indicating robust efficacy in this population.
• In the DED Study, the most frequently observed treatment-emergent adverse event was eye pain, primarily mild and transient.
• In the Neurotrophic Keratopathy Study, cenegermin was well tolerated, with adverse effects mostly being local, mild, and transient, indicating a favorable safety profile.
• The DED Study included patients with moderate-to-severe DED, including those with Sjogren's DED, where cenegermin demonstrated similar efficacy results, indicating potential benefits for this specific subgroup. The Neurotrophic Keratopathy Study involved patients with neurotrophic persistent epithelial defects, with no additional subgroup findings highlighted.