FDA asks advisory committee for guidance on myopia drug

GAITHERSBURG, Md. — The Food and Drug Administration sought guidance yesterday from an advisory panel on how to evaluate a drug intended to retard the progression of juvenile myopia.

Wiley Chambers, MD, deputy director for the Division of Anti-Inflammatory, Analgesics and Ophthalmologic Drug Products for the FDA, asked the panel to develop guidance for such products.

At the meeting, the FDA’s Dermatologic and Ophthalmic Drug Advisory Committee discussed the appropriate sample population for such a drug, whether a drug for myopia is medically necessary, and the appropriate duration for a trial, including how long to follow patients after drug cessation.

The committee expressed concerns regarding the number of children that would be needed to study the potential adverse effects of a drug for myopia.

Previously, Novartis had submitted to the FDA a clinical trial design proposed to evaluate the safety and efficacy of a medical treatment for myopia, company executives explained here.

Novartis did not name the drug or drugs destined for investigation, although in January of this year the company acquired the rights to market pirenzipine, a drug for the treatment of myopia.

Novartis proposed a 3-year study including about 500 children, aged 6 to 12 years, to observe the safety and efficacy of a gel to reduce juvenile myopia. Novartis said the gel would not eliminate myopia but would retard its advancement.

Novartis has indicated it would be willing to have its clinical data used to help develop regulatory guidance for these types of products.

Pirenzipine is currently in phase 2 clinical trials. For more on the early results of those trials, click here.