Universität zu Köln

Zwingelberg, Sarah Barbara, Bachmann, Bjoern O. and Cursiefen, Claus (2020). Real Life Data on Efficacy and Safety of Topical NGF Eye Drops (Cenegermin). Klinische Monatsblat. Augenheilkunde, 237 (12). S. 1455 - 1462. STUTTGART: GEORG THIEME VERLAG KG. ISSN 1439-3999

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Abstract

Background Topical NGF eye drops (Cenegermin) were approved in 2015 as an orphan drug for the treatment of neurotrophic keratopathy (NK). The active substance Cenegermin is a recombinant form of human NGF (nerve growth factor). Objectives Presentation of efficacy and safety of Cenegermin for use in patients in an university real-life setting. Material and Methods Retrospective study at the Koln University Eye Hospital from 2017 to 2019 with n = 11 eyes. Average follow-up was 13.5 +/- 7.1 months. Reasons for treatment were neurotrophic keratopathy stage II and III, clinically mostly in combination with corneal neovascularization. Results Seven eyes with a NK II and 4 eyes with a NK III with a median observation period of 13.6 months (range 1.2-20.3 months) from a total of 11 patients were included. The median patient age was 42.8 +/- 23.6 years (range 18-75 years). Before the start of therapy, the median erosion area measured 3.1 +/- 1.4 x 1.9 +/- 1.1 mm and the median ulcer area had a size of 2.3 +/- 1.1 x 2.1 +/- 0.8 mm. After the start of therapy with Cenegermin (application 6x/day), the epithelial defect closed in all 11 study eyes (100%) within 4-12 weeks (mean: 49 d +/- 9 d). In 9 out of 10 patients (90%) pre-existing corneal neovascularization regressed significantly (p <0.001). Before the start of therapy, a value in the Luneau test of 2.9 +/- 1.9 (minimum 1/6, maximum 4/6) was found and rose to a median value of 4.2 +/- 1.7 (minimum 2(6, maximum 6/6) after 18 months (p = 0.015). Therapy with Cenegermin had no long-term effect on intraocular pressure: the pressure ranged between 13.2 +/- 4.1 mmHg (minimum 8 mmHg, maximum 21 mmHg). Under therapy with NGF eye drops, 67% of the patients, after an initial decrease, showed a long-term improvement in visual acuity (BSCVA) from 0.72 +/- 0.31 to 0.46 +/- 0.29 logMAR after 18 months (p = 0.005). Relapses in form of a corneal erosion in the long-term follow-up were observed in only one eye. One patient had to stop therapy because of local pain, no other local and systemic side effects were observed. Conclusion This real-life series on the use of Cenegermin in a university context shows a good effectiveness of the substance for epithelial closure in various underlying diseases (100% within 12 weeks). There is a long-term improvement in vision and corneal sensitivity. Larger real-life cohorts with various underlying diseases should follow.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Zwingelberg, Sarah Barbara UNSPECIFIED UNSPECIFIED UNSPECIFIED Bachmann, Bjoern O. UNSPECIFIED UNSPECIFIED UNSPECIFIED Cursiefen, Claus UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-309222
DOI:	10.1055/a-1274-3675
Journal or Publication Title:	Klinische Monatsblat. Augenheilkunde
Volume:	237
Number:	12
Page Range:	S. 1455 - 1462
Date:	2020
Publisher:	GEORG THIEME VERLAG KG
Place of Publication:	STUTTGART
ISSN:	1439-3999
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language Ophthalmology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/30922