Is there an anti-adenoviral drug on the horizon?

Abstract

Adenovirus ocular infections are the most common ocular viral infections worldwide. To date, there is no US FDA- or EMA-approved antiviral for the treatment of these infections. However, several agents are currently in industry, academic and investigator sponsored clinical trials. The antiviral agents under evaluation are: NVC-422 (0.33%, NovaBay); ganciclovir (0.15%, Bausch + Lomb; 0.15 and 0.3% Adapt Produtos Oftalmológicos Ltda.; 0.15% Laboratoires Thea); povidone-iodine (2%, Mahidol University; 5%, Betadine for EKC Internet Study) and a combination of 0.4% povidone-iodine and 0.1% dexamethasone (FST-100, Foresight Biotherapeutics; University of Campinas, Brazil). This article will examine the characteristics of these agents and rate their chances for FDA or EMA approval for this indication.

Keywords::

• adenoviral conjunctivitis
• adenovirus
• antiviral
• EKC
• epidemic keratoconjunctivitis

Financial & competing interests disclosure

Romanowski EG has been paid fees by Bausch + Lomb as a specialty advisor. The University of Pittsburgh has been provided research support by Alcon Laboratories, Allergan, Inc. and 3-V Biosciences with the author acting as Principal Investigator. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Key issues

• • There is no US FDA- or EMA-approved antiviral for the treatment of adenoviral conjunctivitis.

• • Presently, there are four antiviral agents being evaluated in clinical trials: i) NVC-422; ii) povidone-iodine; iii) a combination of povidone-iodine and dexamethasone (FST-100) and iv) ganciclovir. However, these antiviral agents have limitations reducing their chances for approval.

• • There is a need for more efficacious candidate antivirals. The treatment regimen of the candidates must be reasonable with a maximum dosing regimen of no more than four-times daily dosing.

• • If new candidate antiviral compounds are not discovered, then we should consider combining antivirals to take advantage of different mechanisms of action. Perhaps the combination of a traditional nucleoside analog antiviral with an antiseptic may increase antiviral efficacy over either of the agents alone.

• • Ideally, the candidate antivirals should also possess antibacterial activity to treat both viral and bacterial conjunctivitis. An anti-inflammatory component could be advantageous, providing it does not prolong infection and recovery from anti-inflammatory withdrawal. This would mandate that regulating agencies be more open to combination therapy.