Rwanda FDA approves Africa’s first low-cost eye disease drug

KIGALI - The Rwanda Food and Drugs Authority (FDA) has approved the sale of BioUcenta™, a low-cost drug for treating eye diseases, marking the first time the medication has reached Africa. The drug will be manufactured by US-based biotech company Bio Usawa, under marketing authorization from Bioeq AG in Switzerland.

BioUcenta™, similar in efficacy to Lucentis® produced by Swiss company Genentech, treats conditions such as diabetic macular edema, Age-related Macular Degeneration (AMD), and diabetic retinopathy, all of which can cause vision loss. The approved drug is expected to arrive in Rwanda in 2026 and will be 80% cheaper than its counterpart, making it more accessible to patients in the region.

“This approval is a major step forward for Bio Usawa and demonstrates Rwanda’s commitment to helping patients access modern medicine,” said Dr. Menghis Bairu, President of Bio Usawa.

Ophthalmologist and co-founder of the Rwanda International Institute of Ophthalmology (RIIO), Prof. Ciku Mathenge, called the approval a milestone for healthcare in Africa. “For a long time, doctors struggled with the lack of timely access to these medicines, while patients suffered due to high costs. Rwanda is taking the lead in developing access to modern medicines,” he said.

Bio Usawa, known for manufacturing vaccines and other advanced medicines, signed an agreement with the Rwanda Development Board (RDB) in November 2024 to establish the country’s first pharmaceutical factory. The facility will initially focus on eye disease treatments before expanding to medicines for cancer and other serious conditions.

Rwanda is positioning itself as a regional hub for healthcare, promoting local pharmaceutical production and improving access to essential medicines for its population and beyond.