Name: Duravyu (vorolanib intravitreal insert) in Wet age-related macular degeneration: Access and distribution
Published: 2026-09-17T18:16:06-04:00

Product information and disease description Product description Product information

Access and distribution

4 evidence topics · 3 sources

Commercial manufacturing facility and registration batches

“The 41,000 square foot Good Manufacturing Process (cGMP) compliant commercial manufacturing facility was built to meet U.S. FDA and EMA standards and will support global manufacturing across the Company’s portfolio, including lead pipeline asset, DURAVYU upon potential regulatory approval.” (opens the source at this quote in a new tab)
“Manufacturing tech transfer of DURAVYU from Watertown to Northbridge began during 2025.” (opens the source at this quote in a new tab)

“DURAVYU registration batches completed to support anticipated NDA filing” (opens the source at this quote in a new tab)

Supply chain for drug substance and injector components

“We source the active pharmaceutical ingredient (API) vorolanib from one supplier, and various raw materials and components for DURAVYU drug product manufacturing from third-party vendors. Injector and packaging components are purchased from several different vendors with the needles supplied by a third-party supplier.” (opens the source at this quote in a new tab)

FDA warning letter concerning the Watertown facility

“citing alleged violations of cGMP requirements in connection with an FDA inspection at our Watertown facility in February 2024” (opens the source at this quote in a new tab)

Anticipated launch preparation and federal pricing programs

“Prepare for the potential commercial launch of DURAVYU” (opens the source at this quote in a new tab)
“In order to be eligible to have our products paid for with federal funds under the Medicaid and Medicare Part B programs and purchased by certain federal agencies and grantees, we must participate in the U.S. Department of Veterans Affairs, (VA), Federal Supply Schedule, (FSS), pricing program.” (opens the source at this quote in a new tab)

Distribution channel, specialty distribution, and patient support programs

No evidence found.