Regulatory Decision Summary for Lucentis

The benefit/risk assessment of Lucentis for improvement of visual acuity in the group of rare-to-very rare diseases, all of which result in visual impairment due to choroidal neovascularization (CNV), is positive. The MINERVA study showed an average improvement in visual acuity of 9.5 letters (range 5.05 to 14.57 letters) as determined using the Early Treatment Diabetic Retinopathy Study (ETDRS) Protocol. This is considered to be a clinically meaningful improvement in vision.

Although the efficacy of Lucentis relative to sham treatment was greater among younger patients (i.e. 13.17 letters among patients under 60 years of age versus 5.04 letters among older patients) and the treatment by age interaction was statistically significant, the impact to the benefit/risk ratio is considered minimal as there is no treatment for visual impairment in CNV secondary to the rare underlying ocular conditions and the prognosis is poor for all ocular conditions and in all age groups.

For the safety, few adverse reactions (ARs) were reported in this study and occurred in 1 or 2 patients. They included ocular ARs that were relatively mild; i.e. conjunctival hemorrhage, choroidal neovascularization, reduction in visual acuity, conjunctivitis, foreign body sensation in the eye, hyperemia, photophobia, and slight increases in intraocular pressure which were transient. The most serious potential ARs are related to the injection procedure (infection, endophthalmitis, rhegmatogenous retinal detachment, retinal tear, iatrogenic traumatic cataract, intraocular inflammation and serious increases in intraocular pressure). The safety profile of Lucentis in these rare ocular conditions is similar as in the other ocular conditions for which Lucentis is authorized. By extension, the benefit/risk ratio for Lucentis in the treatment of these rare conditions is also similar as previously reported for the indications authorized.

Therefore, Health Canada authorizes the extension of the indication for Lucentis for the treatment of visual impairment due to choroidal neovascularization secondary to ocular conditions other than AMD or PM, including but not limited to angioid streaks, post-inflammatory retinochoroidopathy, central serous chorioretinopathy or idiopathic chorioretinopathy.