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Effect of recombinant human nerve growth factor eye drops in patients with dry eye: a phase IIa, open label, multiple-dose study
  1. Marta Sacchetti1,
  2. Alessandro Lambiase1,
  3. Doreen Schmidl2,
  4. Leopold Schmetterer2,
  5. Mauro Ferrari3,
  6. Flavio Mantelli3,
  7. Marcello Allegretti3,
  8. Gerhard Garhoefer2
  1. 1 Department of Sense Organs, University Sapienza of Rome, Rome, Italy
  2. 2 Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria
  3. 3 Dompe farmaceutici SpA, Milano, Italy
  1. Correspondence to Professor Alessandro Lambiase, University Sapienza of Rome, Rome 00185, Italy; alessandro.lambiase{at}uniroma1.it

Abstract

Background Dry eye disease (DED) affects more than 14% of the elderly population causing decrease of quality of life, high costs and vision impairment. Current treatments for DED aim at lubricating and controlling inflammation of the ocular surface. Development of novel therapies targeting different pathogenic mechanisms is sought-after. The aim of this study is to evaluate safety and efficacy of recombinant human nerve growth factor (rhNGF) eye drops in patients with DED.

Methods Forty consecutive patients with moderate to severe DED were included in a phase IIa, prospective, open label, multiple-dose, clinical trial to receive rhNGF eye drops at 20 µg/mL (Group 1: G1) or at 4 µg/mL (Group 2: G2) concentrations, two times a day in both eyes for 28 days (NCT02101281). The primary outcomes measures were treatment-emerged adverse events (AE), Symptoms Assessment in Dry Eye (SANDE) scale, ocular surface staining and Schirmer test.

Results Of 40 included patients, 39 completed the trial. Both tested rhNGF eye drop concentrations were safe and well tolerated. Twenty-nine patients experienced at least one AE (14 in G1 and 15 in G2), of which 11 had at least 1 related AE (8 in G1 and 3 in G2). Both frequency and severity of DED symptoms and ocular surface damage showed significant improvement in both groups, while tear function improved only in G1.

Conclusions The data of this study indicate that rhNGF eye drops in both doses is safe and effective in improving symptoms and signs of DED. Randomised clinical trials are ongoing to confirm the therapeutic benefit of rhNGF in DED.

Trial registration number NCT02101281.

  • clinical trial
  • ocular surface
  • pharmacology
  • tears

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Footnotes

  • Contributors MS: study design, data analysis and interpretation, writing manuscript and final approval. AL: study design and conception, data interpretation, writing manuscript and final approval. DS: patients evaluation and data acquisition, manuscript revision and final approval. LS: patients evaluation and data acquisition, manuscript revision and final approval. MF: data analysis, study design and manuscript writing and final approval. FM: study design and conception, manuscript revision and final approval. MA: study design and manuscript revision and final approval. GG: study design and conception, data interpretation, manuscript revision and final approval.

  • Funding The study was sponsored by Dompe Farmaceutici spa, Via Santa Lucia, 6, 20122 Milan, Italy.

  • Competing interests MS and AL: Consultant—Dompé Farmaceutici SpA. MA, FM and MF: Employee—Dompé Farmaceutici SpA. MS, AL: report personal fees from Dompé Farmaceutici SpA, Italy, outside the submitted work. MA, MS, MF, GG: report personal fees from Dompe Farmaceutici spa, during the conduct of the study.

  • Patient consent for publication Obtained.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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