Article

Ranibizumab approved by Health Canada, gains priority review for sBLA from FDA

Health Canada has approved Novartis Pharmaceuticals Canada’s ranibizumab (Lucentis) for the treatment of visual impairment due to choroidal neovascularization secondary to pathologic myopia (mCNV).

Dorval, Canada and South San Francisco, CA-Health Canada has approved Novartis Pharmaceuticals Canada’s ranibizumab (Lucentis) for the treatment of visual impairment due to choroidal neovascularization secondary to pathologic myopia (mCNV).

According to the company, the treatment is an inhibitor of vascular endothelial growth factor. Treatment of vision loss from mCNV with the drug starts with a single injection, with further injections as needed based on disease activity, which is monitored monthly for the first 2 months, then at least quarterly for up to 1 year. After the first year, frequency of monitoring is at the discretion of the treating physician.

More in this issue: FDA approves VisionCare implant for AMD in patients over 65

The phase III study, on which the approval of the new indication was based, showed that treatment with the drug was superior to the previous standard of care, verteporfin PDT (Visudyne).

The treatment improved mean visual acuity by about 14 letters after 1 year. This result was achieved with a median of two injections over the 12 months. Over 60% of patients in the trial did not need any further injections after 6 months.

Previous treatments for mCNV aimed to stabilize vision but generally did not improve visual acuity.

Additionally, the FDA has accepted to file Genentech’s supplemental biologics license application (sBLA) and granted priority review of the drug for the treatment of diabetic retinopahy.

 

The FDA confirmed action date is Feb. 6.

“We are committed to the treatment of serious eye diseases for patients with diabetes and pleased the FDA is moving forward in its consideration of (the treatment) for diabetic retinopathy,” said Sandra Horning, MD, chief medical officer and head of global product development for Novartis.

The submission is based on results of the RISE and RIDE phase III trials in which meaningful improvements in the disease were observed in a clinically significant proportion of diabetic retinopathy patients treated with the drug at 2 years compared with patients treated with sham injections (control group). Benefits of the drug were maintained during year 3 of treatment.

The safety in the RISE and RIDE phase III trial was consistent with previous studies.

 

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 Europe) Anat Loewenstein, MD, shares insights on the real-world results of remote retinal imaging
(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.
© 2025 MJH Life Sciences

All rights reserved.