Novartis gains European Commission approval for Lucentis®

The European Commission has granted Novartis a new indication for Lucentis® (ranibizumab) to treat patients with visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO and central RVO), a sudden-onset disease where patients have difficulties with daily activities such as reading, cooking and driving.

Lucentis becomes the first anti-VEGF therapy licensed for the treatment of both branch- and central-RVO in the European Union, having demonstrated in pivotal trials that it improves vision and vision-related quality of life for these patients.

RVO results from a blockage forming in a blood vessel in the retina, which is the light-sensitive layer at the back of the eye. In CRVO, the blockage occurs in the main retinal vein at the optic nerve. In BRVO, the blockage occurs in one of the four branches of the main retinal vein. Both CRVO and BRVO can lead to swelling of the macula, which is the central portion of the retina responsible for sharp central vision. This swelling of the macula, or macular edema, is the most common cause of visual impairment in patients with RVO. RVO often leads to increased production of vascular endothelial growth factor (VEGF), which can exacerbate RVO complications including macular edema.

“This is an important step forward in the management of patients with RVO because the disease is difficult to treat with few available options,” said Ian Pearce, Consultant Ophthalmologist, Royal Liverpool University Hospital. “Laser treatment can provide partial improvement for BRVO patients but many do not regain their vision. Laser treatment for patients with CRVO is not considered effective and prognosis is worse than that for BRVO.”

Approval of Lucentis was based on data from two pivotal Phase III studies, BRAVO in BRVO patients and CRUISE in CRVO patients, that showed early and sustained improvement in vision in patients at six months with monthly Lucentis treatment compared with standard of care, and visual acuity gains were maintained from months seven through 12 with as-needed dosing of Lucentis.

In BRAVO, approximately 60% of BRVO patients treated with monthly Lucentis gained at least 15 letters of visual acuity at six months, compared with 29% of those treated according to current standard practice. Mean gains from baseline in visual acuity at six months were 18.3 letters for BRVO patients, compared with gains of 7.3 letters with current standard practice.

In CRUISE, approximately 48% of CRVO patients treated with monthly Lucentis gained at least 15 letters of visual acuity at six months, compared with 17% of those treated according to current standard practice. Mean gains from baseline in visual acuity at six months were 14.9 letters for CRVO patients, compared with gains of 0.8 letters with current standard practice.

“Lucentis has proven to be an important therapy for people with difficult-to-treat eye conditions, including wet age-related macular degeneration and patients with vision loss due to diabetic macular edema,” said David Epstein, Division Head of Novartis Pharmaceuticals. “Lucentis is the first anti-VEGF therapy available for patients with both BRVO and CRVO. We are very pleased that another group of patients with debilitating vision loss has access to an effective licensed therapy.”

Safety data from the BRAVO and CRUISE trials were similar to previous studies with Lucentis in patients with wet AMD and visual impairment due to DME, and no new adverse events were reported. At six months the most common ocular adverse events that occurred in the Lucentis-treated patients included conjunctival hemorrhage (48%) and eye pain (17%). In the BRAVO trial, there was one case of endophthalmitis, two arterial thrombo-embolic events, fatal hemorrhagic stroke and non-fatal myocardial infarction. One case of non-fatal myocardial infarction was reported in the sham group. In the CRUISE trial, systemic safety events included one case of either myocardial infarction or acute coronary syndrome in each of the three groups. There were no cerebrovascular accidents or deaths.

Lucentis is an antibody fragment that is injected into the eye and acts by neutralizing VEGF. Lucentis is currently licensed in more than 85 countries for the treatment of wet age-related macular degeneration (AMD) and in more than 30 countries for the treatment of visual impairment due to diabetic macular edema (DME).

Lucentis was developed by Genentech and Novartis. Genentech has the commercial rights to Lucentis in the United States, where Lucentis is also approved for the treatment of macular edema following RVO. Novartis has exclusive rights in the rest of the world.