FDA greenlights Genentech's eye implant for macular degeneration. Will it be a tough sell?

Susvimo, Genentech
With an approval in hand for Genentech's Susvimo, which is a delivery system with ranibizumab, Roche will try to extend the system to Lucentis' other indications. The surgically placed implant is the size of a grain of rice. (Genentech)

Two treatments per year as opposed to 12, what’s not to like? In two words—surgical implants.

That’s the stigma Genentech will potentially face as it attempts to convince patients with wet age-related macular degeneration (AMD) to try a treatment that requires surgery.

Friday, the FDA approved Genentech’s Susvimo, a port delivery system with a customized formulation of ranibizumab, the active ingredient in Lucentis. Now, the trick for Genentech and parent company Roche could be to get patients to accept having surgery to have an implant the size of a grain of rice placed under the upper eyelid. Susvimo is refilled every six months. 

In the treatment of AMD, the refillable eye implant is the first of its kind approach, requiring a single outpatient procedure, followed by refilling visits every six months. In contrast, injectable Lucentis' optimal dosing is once a month.

“[This] is a very exciting choice for patients,” said Chris Brittain, the global head of ophthalmology development at Genentech. “It’s a surgically implanted device. Therefore, for us it’s really important to ensure that surgeons are very well trained.”

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As part of a phase 3 trial, more than 200 surgeons were instructed how to install and refill Susvimo. For new trainees, Roche developed a virtual reality program to help guide doctors through the implant and maintenance processes.

For the launch, Roche plans to deploy a mix of in-person and digital training tools for providers. Separately, Roche is also piloting a remote vision monitoring app that in the future could help patients track changes in sight between treatments. Patients in the pilot can download the smartphone app that provides vision tests and sends alerts straight to doctors if a patient’s sight starts to deteriorate.

The approval is based on the phase 3 study, which showed Susvimo extended time between treatments up to six months for more than 98% of patients and provided vision outcomes equivalent to monthly Lucentis injections.

RELATED: Regeneron shoots for longer Eylea dosing interval in diabetic retinopathy with NIH data

Susvimo was well-tolerated, with a favorable benefit-risk profile. In the trial, the most common adverse events were conjunctival hemorrhage, conjunctival hyperemia, iritis and eye pain. Cases of endophthalmitis, an eye infection, also were reported.

Roche hopes to extend the delivery system to Lucentis’ other indications. A phase 3 trial is underway testing the delivery tech on those with diabetic macular edema (DME).

The company could also extend the system to other eye drugs in its portfolio. One of these, faricimab, a bispecific antibody for the treatment of wet AMD and DME, is under review by the FDA, with a decision expected early next year. It could become the first medicine to treat two of the distinct pathways (Ang-2 and VEGF-A) that cause retinal diseases.

RELATED: FDA accepts Roche's 6-month Lucentis implant for priority review

The new drug and the delivery system will help Roche in its pursuit of Regeneron’s Eylea, which works on an eight-week dosing schedule and hopes to eventually gain approval for a 16-week regimen. Eylea racked in $4.95 billion in U.S. sales last year. Lucentis' sales came in at $1.61 billion.

For its part, Lucentis can be dosed less frequently but with the caveat that it may not be as effective. The drug's label notes that after an initial monthly dosing for three months, patients can be prescribed an average of four to five doses over the next nine months. 

The wet AMD market is huge. The condition, also known as neovascular AMD, is the leading cause of blindness in people older than 60, impacting 20 million worldwide.

“Anti-VEGF therapy brings significant benefit to people with nAMD, but optimal results require frequent trips to the doctor’s office for eye injections. This burden leaves many people under-treated and susceptible to vision loss,” Roche’s chief medical officer Levi Garraway, M.D., Ph.D., said in a statement in June when the FDA accepted a biologics license application for Susvimo.