Article

ThromboGenics resubmits BLA for ocriplasmin

ThromboGenics NV has resubmitted a biologics license application (BLA) to the FDA for ocriplasmin intravitreal injection, 2.5 mg/ml, for the treatment of symptomatic vitreomacular adhesion (VMA) including macular hole.

Leuven, Belgium-ThromboGenics NV has resubmitted a biologics license application (BLA) to the FDA for ocriplasmin intravitreal injection, 2.5 mg/ml, for the treatment of symptomatic vitreomacular adhesion (VMA) including macular hole.

In February, the FDA indicated that it intended to assign a priority review designation to the original BLA submission for the same indication, which had been filed in December. The re-submission will allow ThromboGenics to meet the FDA’s priority review timelines and manage the phasing of its resources to support both its European and U.S. ocriplasmin filings. The European Medicines Agency is reviewing the company’s marketing authorization application (MAA) for ocriplasmin for the same indication.

Patrik De Haes, MD, ThromboGenics’ chief executive officer, said: “The re-submission of the BLA filing is a significant step in our strategy to commercialize ocriplasmin in the United States, if approved. Gaining priority review designation for ocriplasmin, as anticipated, would further validate the potential of this novel pharmacological drug in treating symptomatic VMA including macular hole.”

Ocriplasmin has successfully completed two phase III clinical trials for the pharmacologic treatment of symptomatic VMA. In March, ThromboGenics signed a strategic partnership with Alcon (Novartis) for the commercialization of ocriplasmin outside the United States. ThromboGenics and Alcon intend to share the costs equally of developing ocriplasmin for several vitreoretinal indications.

For more articles in this issue of Ophthalmology Times eReport, click here.

Newsletter

Don’t miss out—get Ophthalmology Times updates on the latest clinical advancements and expert interviews, straight to your inbox.

Related Videos
(Image credit: Ophthalmology Times) Two-wavelength autofluorescence for macular xanthophyll carotenoids with Christine Curcio, PhD
(Image credit: Ophthalmology Times) FLIO and the brain: Making the invisible visible with Robert Sergott, MD
(Image credit: Ophthalmology Times) Structure-function correlates using high-res OCT images with Karl Csaky, MD, PhD
(Image credit: Ophthalmology Times) SriniVas Sadda, MD, on high-res OCT of atrophic and precursor lesions in AMD
(Image credit: Ophthalmology Times) Christine Curcio, PhD, shares histology update supporting review software and revised nomenclature for <3 μm OCT
1 expert is featured in this series.
1 expert is featured in this series.
1 expert is featured in this series.
1 expert is featured in this series.
Steven R. Sarkisian, Jr., MD, ABO, speaks about glaucoma at the 2025 ASCRS annual meeting
© 2025 MJH Life Sciences

All rights reserved.