Friday, May 31, 2013

Lucentis® receives positive opinion for patients with myopic choroidal neovascularization showing vision gains with only two injections

Novartis has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for Lucentis® (ranibizumab) to treat patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (myopic CNV). 

CNV is the most common vision-threatening complication of high myopia. Myopic CNV usually affects patients younger than 50 years old so any associated vision loss can have not only a significant impact on their quality of life but also on their productivity and to society. In patients with untreated myopic CNV the long-term prognosis is poor with approximately 90% of affected patients developing severe vision loss after five years.

The submission was supported by data from the Novartis-sponsored clinical trial, RADIANCE, that showed Lucentis provides superior improvement in visual acuity compared with the current licensed standard of care, Visudyne® (verteporfin PDT), in patients with myopic CNV. These new data showed around 40% of Lucentis treated patients compared with 15% of Visudyne treated patients gained 15 or more letters of visual acuity at month three[4]. Mean visual acuity gains of approximately 14 letters at one year were demonstrated with Lucentis; this was with a median of 2.0 injections.

In this pivotal Phase III study patients were randomized to one of three treatment arms: Lucentis treatment based on visual acuity stability (group 1) or disease activity (group 2); or Visudyne treatment (group 3). Subjects randomized to Visudyne could be given Lucentis after three months based on persistent disease activity. The primary endpoint was Lucentis superiority to Visudyne based on the mean visual acuity change from baseline to month three. Patients were followed for twelve months.

Both the Lucentis treatment groups were statistically superior to the Visudyne treatment group. Mean letter gains at month three from baseline in the two Lucentis groups (groups 1 and 2) were 12.1 and 12.5 letters, respectively, compared to a 1.4 letter gain in the Visudyne treatment arm (group 3). At twelve months, the mean letter gains from baseline were 13.8 (group 1), 14.4 (group 2) and 9.3 (group 3).

The safety profile of Lucentis was consistent with that observed in other studies as well as real-world experience and no new ocular/non-ocular safety risks were identified. The most common adverse events occurring in more than ten percent of patients, at twelve months, were conjunctival hemorrhage (ocular) and nasopharyngitis (non-ocular).

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