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The following is a summary of “Recombinant human nerve growth factor (cenegermin) for moderate-to-severe dry eye: phase II, randomized, vehicle-controlled, dose-ranging trial,” published in the July 2024 issue of Ophthalmology by Wirta et al.

Dry eye disease (DED) involves neurosensory abnormalities and benefits from cenegermin, a topical recombinant human nerve growth factor enhancing corneal healing.

Researchers conducted a retrospective study assessing cenegermin’s effectiveness and safety in moderate-to-severe DED and determining the best dosing approach.

They enrolled patients with DED, including Sjogren’s DED. Participants were assigned to receive cenegermin 20 mcg/mL 3 times daily (t.i.d.), cenegermin 20 mcg/mL twice daily (b.i.d.), or vehicle once daily for 4 weeks, followed by a 12-week follow-up. The primary endpoint assessed changes in Schirmer I score from baseline to week 4. Secondary endpoints included responder rates (Schirmer I test > 10 mm/5 min) post-treatment and changes in Symptoms Assessment iN Dry Eye (SANDE) scores from baseline to the end of follow-up. Statistical significance was evaluated using a 1-sided test (α = 0.025).

The result showed that mean changes in Schirmer I scores did not reveal statistically significant differences between either the cenegermin group and the vehicle in 4 weeks (treatment difference; 95% CI: t.i.d., 2.60 mm and b.i.d., 3.99 mm vs. 1.68 mm [t.i.d.: 0.93; −1.47 to 3.32, P=0.078; b.i.d.: 2.31; −0.08 to 4.70, P=0.066]). A greater proportion of patients receiving cenegermin t.i.d. and b.i.d. experienced a positive response compared to the inactive treatment (t.i.d.: 25.9% [21/81, P=0.028]; b.i.d.: 29.3% [24/82, P=0.007] vs. 11.9% [10/84]), with statistical significance (set at P<0.025) in a twice-a-day dose. Cenegermin t.i.d. achieved statistically significant reductions (P<0.025) in SANDE scores versus vehicle, maintained through follow-up (P value range, 0.002–0.008); mild, transient eye pain was the predominant treatment-emergent adverse event. Comparable outcomes were noted in patients with Sjögren’s DED.

Investigators concluded that, despite not meeting the primary endpoint, cenegermin was well tolerated and significantly improved patient-reported dry eye symptoms, necessitating larger studies.

Source: bmcophthalmol.biomedcentral.com/articles/10.1186/s12886-024-03564-w