Article

Genentech submits sBLA for diabetic retinopathy treatment

Genentech has submitted a supplemental Biologics License Application (sBLA) to the FDA for its treatment of diabetic retinopathy, ranibizumab injection (Lucentis).

 

South San Francisco, CA-Genentech has submitted a supplemental Biologics License Application (sBLA) to the FDA for its treatment of diabetic retinopathy, ranibizumab injection (Lucentis).

The submission is based on results of the RISE and RIDE phase III clinical trials demonstrating the safety and efficacy of the treatment for diabetic retinopathy.

More from this issue: Ophthotech initiates expansion studies of wet AMD therapy

“As the number of people impacted by diabetes continues to rise, so too will the number of people affected by diabetic eye disease,” said Sandra Horning, MD, chief medical officer and head of global product development for Genentech. “We are committed to helping more people with diabetes prevent vision loss and look forward to continuing our discussions with the FDA about these data.”

During the RISE and RIDE trials, a clinically significant proportion of diabetic retinopathy patients treated with ranibizumab showed meaningful improvements in their disease at 2 years compared with patients treated with sham injections (control group).

 

NEXT: Page 2

 

The benefits of ranibizumab on the signs of diabetic retinopathy were maintained during the third year of the treatment.

Further reading: varying ranibizumab therapy may improve DME results

 

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

 

 

To receive weekly clinical news and updates in ophthalmology, subscribe to the Ophthalmology Times eReport.

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)  ASCRS 2025: Joaquin De Rojas, MD, leverages machine learning model to predict arcuate outcomes
(Image credit: Ophthalmology Times) ASCRS 2025: AnnMarie Hipsley, DPT, PhD, presents VESA for biomechanical simulation of presbyopia progression
Shehzad Batliwala, DO, aka Dr. Shehz, discussed humanitarian ophthalmology and performing refractive surgery in low-resource, high-risk areas at the ASCRS Foundation Symposium.
(Image credit: Ophthalmology Times) ASCRS 2025: Advancing vitreous care with Inder Paul Singh, MD
(Image credit: Ophthalmology Times) The Residency Report: Study provides new insights into USH2A target end points
Lisa Nijm, MD, says preoperative osmolarity testing can manage patient expectations and improve surgical results at the 2025 ASCRS annual meeting
At the 2025 ASCRS Annual Meeting, Weijie Violet Lin, MD, ABO, shares highlights from a 5-year review of cross-linking complications
Maanasa Indaram, MD, is the medical director of the pediatric ophthalmology and adult strabismus division at University of California San Francisco, and spoke about corneal crosslinking (CXL) at the 2025 ASCRS annual meeting
(Image credit: Ophthalmology Times) ASCRS 2025: Taylor Strange, DO, assesses early visual outcomes with femto-created arcuate incisions in premium IOL cases
(Image credit: Ophthalmology Times) ASCRS 2025: Neda Shamie, MD, shares her early clinical experience with the Unity VCS system
© 2025 MJH Life Sciences

All rights reserved.