Roche has bagged an expanded approval from regulators in the USA for its injectable eye drug Lucentis as a treatment for a common cause of vision loss.

The Swiss major’s Genentech unit says that the US Food and Drug Administration has approved Lucentis (ranibizumab) for the treatment of macular oedema following retinal vein occlusion (RVO). The green light for this new indication (it is already approved for wet age-related macular degeneration) came after a six-month priority review.

The agency backed the new use based on the 397-patient BRAVO and 392-patient CRUISE studies. In the first trial, the percentage of patients in the Lucentis 0.5mg study arm who gained 15 or more letters in best-corrected visual acuity (BCVA) from baseline at month six was 61% compared with 29% in the sham injection arm. In the CRUISE study, the percentage of patients on Lucentis 0.5mg study arm who gained 15 or more letters in BCVA after six months was 48% compared with 17% in the sham arm.

Roche’s chief medical officer Hal Barron said the approval “provides an important new medicine for people experiencing the unexpected vision loss associated with macular oedema following RVO,” He noted that in the clinical trials, “significantly more people treated with monthly Lucentis showed sustained vision improvement during the six-month study with an effect seen as early as seven days”.

RVO affects more than one million people in the USA and is the second-most common cause of vision loss due to retinal vascular disease, which, Roche noted, can develop over a long period of time or occur suddenly. It happens when the normal blood flow through a retinal vein becomes blocked, causing swelling and haemorrhages in the retina.

Sudden blurring or vision loss in all or part of one eye is common with RVO, although loss of vision can develop over a long period of time. It typically affects patients who are over 50 and the incidence increases with age and people with a history of high blood pressure, hypertension, diabetes and atherosclerosis are at an increased risk for developing RVO.

The new approval will boost already strong sales of Lucentis which is partnered with Novartis. US turnover of the drug for the first quarter jumped 27% to 327 million Swiss francs,