ThromboGenics re-submits
BLA with US FDA ThromboGenics has resubmitted a Biologics License Application (BLA) with the US Food and Drug Administration (FDA) for ocriplasmin intravitreal injection, 2.5 mg/mL, for the treatment of symptomatic vitreomacular adhesion (VMA) including macular hole. In February 2012, the FDA indicated that it intended to assign a Priority Review designation to the original BLA submission for the same indication filed in December 2011. A company spokeswoman said the re-submission will allow ThromboGenics to meet the FDA's Priority Review timelines and to manage the phasing of its resources to support both its European and US ocriplasmin filings.
www.thrombogenics.com
Latest Articles
Towards a Unified IOL Classification
The new IOL functional classification needs a strong and unified effort from surgeons, societies, and industry.
The 5 Ws of Post-Presbyopic IOL Enhancement
Fine-tuning refractive outcomes to meet patient expectations.
AI Shows Promise for Meibography Grading
Study demonstrates accuracy in detecting abnormalities and subtle changes in meibomian glands.
Are There Differences Between Male and Female Eyes?
TOGA Session panel underlined the need for more studies on gender differences.
Simulating Laser Vision Correction Outcomes
Individualised planning models could reduce ectasia risk and improve outcomes.
Need to Know: Aberrations, Aberrometry, and Aberropia
Understanding the nomenclature and techniques.
When Is It Time to Remove a Phakic IOL?
Close monitoring of endothelial cell loss in phakic IOL patients and timely explantation may avoid surgical complications.
Delivering Uncompromising Cataract Care
Expert panel considers tips and tricks for cataracts and compromised corneas.
Organising for Success
Professional and personal goals drive practice ownership and operational choices.