Genentech’s pre-filled syringe for diabetic retinopathy wins FDA nod

Roche‘s (OTC:RHHBY) Genentech announced today that the FDA approved its 0.3-mg pre-filled syringe as a new way to administer Lucentis to diabetic retinopathy patients.

The company’s drug is the only FDA-approved medicine indicated for the treatment of diabetic retinopathy. The 0.3-mg pre-filled syringe is the first device of its kind approved to deliver an anti-vascular endothelial growth factor agent to patients with diabetic retinopathy and diabetic macular edema.

“Diabetic retinopathy is a serious condition that affects millions of people in the U.S.,” Dr. Sandra Horning, chief medical officer & head of global product development at Genentech, said in prepared remarks. “Today’s approval of the Lucentis 0.3-mg pre-filled syringe reinforces our commitment to advancing therapy for those impacted by this vision-threatening disease.”

Physicians administering Lucentis using the 0.3-mg pre-filled syringe can simply snap off the syringe cap, attach an injection needle to the syringe and adjust the dose, according to Genentech.

The drug-device combo will be available in the second quarter of this year, the company reported.

The 0.5-mg pre-filled syringe for Lucentis was approved by the FDA in Oct. 2016 and is indicated to treat wet age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovasculariztaion.

Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.

Registration is Open for DeviceTalks Boston Registration is open for DeviceTalks Boston! Join us on June 5-6, 2019, as we explore the trends and technology that are shaping the future of the medical device industry. REGISTER NOW