Meeting News Coverage

Corneal cross-linking faces various regulatory hurdles in US

SAN FRANCISCO — Corneal collagen cross-linking faces numerous regulatory approvals in the United States by virtue of being a drug-device combination, an expert said here.

The procedure is approved in the European Union and other regions but is not approved in the U.S. Several clinical trials are ongoing.

"Riboflavin and UVA light are regulated as a combination product both in Europe and in the United States," Barbara Fant, PharmD, said during a symposium at the American Society of Cataract and Refractive Surgery meeting. "That presents some definite regulatory challenges. A combination product presents challenges in and of itself. If we have an approved drug and an approved device, that’s the easiest pathway to the market. In the U.S., we’re looking at both a new drug and a new device."

In the U.S., a company can submit one new drug application for riboflavin as a drug and a separate application for ultraviolet light as a device. The U.S. Food and Drug Administration has an Office of Combination Products to handle combined procedures such as cross-linking, Fant said.

Off-label use is an option for ultraviolet light but not for riboflavin, Fant said. There is no ophthalmic riboflavin solution commercially available in the U.S. Compounding pharmacies have to formulate ophthalmic riboflavin solution, but this may be challenging because compounding pharmacies are under strict scrutiny, she said.

Orphan drug designation is also an option, Fant said.

The FDA review process is costly; a company applying for approval can invest hundreds of millions of dollars in research, development and regulatory fees, Fant said.

Disclosure: Fant is president and principal regulatory consultant of Clinical Research Consultants, which is sponsoring investigational new device applications and clinical studies for Sooft Italia products.

SAN FRANCISCO — Corneal collagen cross-linking faces numerous regulatory approvals in the United States by virtue of being a drug-device combination, an expert said here.

The procedure is approved in the European Union and other regions but is not approved in the U.S. Several clinical trials are ongoing.

"Riboflavin and UVA light are regulated as a combination product both in Europe and in the United States," Barbara Fant, PharmD, said during a symposium at the American Society of Cataract and Refractive Surgery meeting. "That presents some definite regulatory challenges. A combination product presents challenges in and of itself. If we have an approved drug and an approved device, that’s the easiest pathway to the market. In the U.S., we’re looking at both a new drug and a new device."

In the U.S., a company can submit one new drug application for riboflavin as a drug and a separate application for ultraviolet light as a device. The U.S. Food and Drug Administration has an Office of Combination Products to handle combined procedures such as cross-linking, Fant said.

Off-label use is an option for ultraviolet light but not for riboflavin, Fant said. There is no ophthalmic riboflavin solution commercially available in the U.S. Compounding pharmacies have to formulate ophthalmic riboflavin solution, but this may be challenging because compounding pharmacies are under strict scrutiny, she said.

Orphan drug designation is also an option, Fant said.

The FDA review process is costly; a company applying for approval can invest hundreds of millions of dollars in research, development and regulatory fees, Fant said.

Disclosure: Fant is president and principal regulatory consultant of Clinical Research Consultants, which is sponsoring investigational new device applications and clinical studies for Sooft Italia products.

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