Bayer’s Aflibercept Injection (EyleaTM) for intravitreal Use Receives DCGI Approval for Diabetic Macular Edema Indication

* Intravitreal Aflibercept is a highly targeted, evidence-based treatment administered via injection directly in the area of swelling in the eye.

* Diabetic macular edema is the most common cause of moderate vision loss in Indian diabetic patients with diabetic retinopathy 

* This new indication for intravitreal aflibercept (EyleaTM) provides an additional treatment option for patients with diabetic macular edema in India

Bayer in India today announced that the Drugs Controller General of India (DCGI) has approved a new indication for intravitreal Aflibercept (EyleaTM) injection solution to treat Diabetic Macular Edema (DME). The approval of Aflibercept injection for intravitreal use presents a new and alternative treatment option to currently available therapies, for patients with DME.

India is estimated to have the second highest number of diabetes cases in the world, with 77 million cases projected to grow to more than 100 million cases by 2030.[1] Diabetic macular edema (DME) is the most common cause of moderate vision loss in patients with diabetic eye diseases, and is expected to affect 22.4 million Indians within the next two decades.[2]

Explaining the magnitude of this disease burden, Dr. Shobhit Chawla, Sr. Vitreo-Retina Consultant, Lucknow and President, Vitreo-Retina Society of India  said, “Based on existing medical literature, we can estimate that diabetic eye disease is found approximately in every fifth person living with diabetes in urban India, and every tenth person living with diabetes in rural India.[3] However, very few diabetic patients get screened proactively. The current pandemic has exacerbated this situation, with many patients waiting until symptoms of vision loss worsen.

Manoj Saxena, Managing Director Bayer Zydus Pharma said, “India has a large and growing prevalence of diabetes, coupled with low levels of awareness and diagnosis of vision-related complications resulting from the condition. Since a significant number of people living with diabetes are under 50, are working and may have dependent families, the economic and social burden of such complications is high.[4] Intravitreal Aflibercept (EyleaTM) offers patients impacted by diabetic vision loss a new option to be proactive and stay ahead of the disease, thereby allowing patients to maintain their vision and to continue to participate in important daily activities such as reading, working and driving.”

He continued, “We are also ensuring this innovative and effective treatment remains accessible through our unique patient support program as well as financing partnership for patients. We look forward to extending our commitment to preserving healthy vision for patients in India, and continue to emphasize a proactive approach to disease management that best maintains and supports their journey to better health.”

About Diabetic Macular Edema (DME)

Diabetic Macular Edema (DME) occurs when high blood sugar levels damage capillaries that leak fluid into the retina, resulting in swelling and blurred vision. By targeting and stopping the release of the VEGF protein that causes fluid leakage and new blood vessel growth, anti-VEGF therapies like intravitreal aflibercept (EyleaTM) rapidly reduce swelling and restore central vision.   

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2019, the Group employed around 104,000 people and had sales of € 43.5 billion. Capital expenditures amounted to € 2.9 billion and R&D expenses to € 5.3 billion.