Neurotrophic Keratopathy Eye Drops May Be First Line Therapy

RGN-259 is a safe and effective therapy for neurotrophic keratopathy (NK), according to research presented at the American Academy of Ophthalmology 2021 meeting in New Orleans, held November 12-15.

Researchers conducted a study to assess the efficacy of 0.1% RGN-259 in persistent epithelial defects (PEDs) among NK patients. Inclusion criteria included failure with at least 1 week of conventional treatment, stage 2 or 3 NK, and corneal sensitivity of 4.5 cm or less.

A total of 18 participants were randomly assigned to receive RGN-259 or a placebo. The participants received 5 daily doses for 28 days, with a 2 week follow-up. The primary endpoint was considered the proportion of patients with complete PED healing at day 29.

The primary endpoint was not met, the researchers noted. However, 60% in the RGN-259 group (n=6) experienced complete healing at day 29, compared with 12.5% (n=1) in the placebo group (P =.0656). At day 43, a notable difference (P <.05) was found: 50% (n = 5) with RGN-259 vs 0% (n = 0) with placebo. 

According to the research, 1 serious adverse event unrelated to RGN-259 was reported, but no treatment emergent adverse events led to study discontinuation.

“In a small study, the efficacy and safety of RGN-259 validate that RGN-259 represents a potential first-line therapy for NK,” the presenters reported.  

Reference 

Watson M, Ousler III GW, Yang J, Sosne G. SEER-1 demonstrates safety and efficacy of RGN-259 for neurotrophic keratopathy. Poster presented at: The American Academy of Ophthalmology 2021 Annual Meeting; November 12-15, 2021; New Orleans. Abstract PO176.