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.
Steve MacMillan took over as CEO of Hologic in 2013, drawing on his experience at medtech titans like Stryker and Johnson & Johnson. Since then, Hologic has grown into a $3 billion business.
At DeviceTalks Boston, MacMillan will provide exclusive insights into the Massachusetts-based company and its evolving definition of women's healthcare. You don't want to miss it!
Use code WOMENSHEALTH to save an additional 10%.