A first in China – Frontera Therapeutics Doses First Patient in a Clinical Trial of FT-003 Gene Therapy for the Treatment of DME

BEDFORD, Mass., and SHANGHAI, China, June 13th 2023 Frontera Therapeutics announced another major clinical milestone: FT-003 was successfully dosed for the first patient with Diabetic Macular Edema (DME) in the Ophthalmic Hospital of Tianjin Medical University. This marks the first treatment of gene therapy  for this indication in China.

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Li Xiaorong team of Tianjin Medical University Eye Hospital took the lead in completing AAV gene therapy for diabetic macular edema. The first patient-in China.

On May 19th, 2023, Professor Li Xiaorong, Ophthalmic Hospital, Tianjin Medical University, successfully completed the administration of AAV gene drug FT-003 for the treatment of Diabetic Macular Edema (DME) in the first patient in China, which is first in classof AAV gene therapy in the treatment of DME in China.

Professor Li Xiaorong said that this is the second clinical study conducted at Tianjin Medical University Eye Hospital with FT-003 and Frontera this time to evaluate the safety, tolerability and efficacy of FT-003 in patients with DME. There are currently no approved  gene therapy treatments for  DME anywhere in the world. The results of a FT-003 nonclinical study completed by Frontera   showed that FT-003 intraocular injection can effectively target the retinal histiocytes of animals and enable them to secrete an anti-VEGF protein continuously and stably, thereby reducing fundus vascular leakage, reducing the leakage area and lesion area of model animals, with no safety concerns. This human trial is the first AAV gene therapy for DME in China, and it is hypothesized that one injection will be effective in the long term to improve the visual function of patients and reduce the need for other anti-VEGF therapies. The 14th Five-Year National Eye Health Plan also clearly states that the diagnosis and treatment standards of key diseases should be formulated for diabetic retinopathy, the management model of patients with chronic ophthalmopathy should be improved, and the burden of disease and the rate of blindness should be reduced. This study is also one of the important actions of our hospital to carry out the National Eye Health Program.

About DME

Diabetic Retinopathy (DR) is one of the most common microvascular complications in Diabetic patients (including type I and type II) and the leading cause of visual impairment in patients aged 25-74 years. DME is the main cause of vision loss in patients with diabetic retinopathy. DME occurs within 10 yr in 20% of patients with type 1 diabetes and 14 to 25% with type 2 diabetes. It is estimated that there are about 9 million DME patients in China, which brings great burden to patients and society.

At present, the treatment modalities of DME include laser photocoagulation, anti-VEGF therapy and hormone injection therapy, among which anti-VEGF drugs are expensive and require regular repeated intraocular injections, and the possible risks such as intraocular hemorrhage and infection affect the compliance and treatment effect of patients. There is an urgent need for new treatments to increase patients’ treatment compliance, reduce the economic burden of patients, and meet the long-term treatment needs of patients with DME.