Novartis drug vs diabetic macular edema gets FDA okay

MANILA, Philippines - The Philippine Food and Drug Administration (FDA) has granted research-based Swiss health care company Novartis a new indication for ranibizumab to treat vision loss due to diabetic macular edema (DME), one of the most feared diabetes complications that can cause disabling vision loss.

Ranibizumab is the first US FDA-approved drug specifically developed for the treatment of “wet” age-related macular degeneration (AMD), a leading cause of blindness in older adults.

Laser therapy, the current standard of care for DME, provides stabilization of vision in many patients, but generally does not improve vision.

Ranibizumab is the first licensed therapy to significantly improve both vision and vision-related quality of life in patients with visual impairment due to DME.

The Philippine FDA’s approval of the new ranibizumab indication was based on data from two Novartis-sponsored clinical trials, RESTORE and RESOLVE, which showed that ranibizumab was superior in providing rapid and sustained visual acuity gain versus placebo therapy or laser therapy, the current standard of care.

The RESTORE study showed patients treated with ranibizumab alone or with ranibizumab plus laser therapy gained an average of 6.8 letters and 6.4 letters, respectively, in visual acuity at 12 months compared to baseline, while laser-treated patients gained an average of 0.9 letters as measured on a standard eye chart.

The RESOLVE study showed that ranibizumab-treated patients gained an average of 10.3 letters in visual acuity at 12 months compared to baseline while placebo-treated patients, some of who also received laser treatment, lost an average of 1.4 letters.

“In these clinical trials, ranibizumab-treated patients began to recover their vision as early as eight days after the first injection on average, and vision improvement was maintained at one year,” said Prof. Gabriele Lang of the University Eye Hospital of University of Ulm, Germany.

“The vision improvement for many of these patients was clinically significant, meaning that they regained the ability to carry out day-to-day activities such as driving,” Lang said.

“Ranibizumab has become the gold standard treatment for wet AMD and its use has stimulated research into other eye conditions,” said David Epstein, division head of Novartis Pharmaceuticals.

“Our continued investment in the clinical development of ranibizumab means that another group of patients who are at risk of losing their eyesight will have the option of a licensed therapy that could help save their vision,” Epstein said.

The pivotal data from RESTORE and RESOLVE studies are further supported by results of an independent US study examining ranibizumab for the treatment of DME compared to standard of care.

Conducted by the Diabetic Retinopathy Clinical Research Network (DRCR.net), this study showed that at 12 months patients treated with ranibizumab plus laser gained an average of nine letters in visual acuity compared to baseline while patients treated with laser therapy alone gained an average of three to four letters.

In addition, the study demonstrated superior gains in visual acuity among ranibizumab-treated patients up to two years, with a reduced number of ranibizumab injections required the second year compared to the first.

Specifically, there was a median of only two to three injections required in the second year of treatment compared to a median of eight to nine injections required in the first year.

DME is a consequence of diabetic retinopathy, the most common diabetic eye complication. It is characterized by changes in the blood vessels of the retina, which is the light-sensitive layer at the back of the eye.

In patients with DME, leakage from these abnormal blood vessels occurs in the central portion of the retina, called the macula. Because this part of the eye is responsible for sharp central vision, DME can lead to significant visual impairment.

Ranibizumab offers an entirely new pharmacological approach to treatment for visual impairment due to DME compared to the current standard of care, which involves the use of laser burns to stop capillary leakage and reduce swelling.

Ranibizumab is an antibody fragment that is injected into the eye and neutralizes vascular endothelial growth factor (VEGF), a protein that is known to increase vascular permeability, resulting in capillary leakage and macular edema in patients with diabetes.

Ranibizumab is currently licensed in more than 85 countries for the treatment of wet AMD. It receives continuous safety monitoring via a systematic pharmacovigilance system.