Leuven - Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing next generation standard-of-care ophthalmic therapies, with a focus on diabetic macular edema (DME), today issues its business and financial update for the sixth-month period ending June 30, 2020.

Oxurion is focused on developing an industry leading DME franchise based on novel therapies designed to potentially provide improved visual outcomes for all DME patients.

The Company is progressing its pipeline of innovative clinical drug candidates for treating DME. DME is a significant global healthcare problem and the major cause of vision loss in diabetic patients worldwide.

Oxurion's clinical development pipeline consists of two novel products with different and complimentary, non-VEGF, modes of action: THR-149 is a potent plasma kallikrein inhibitor with the potential to become the treatment of choice for DME patients who respond sub-optimally to anti-VEGF therapy.

THR-687 is a best in class small molecule pan-RGD integrin antagonist being developed to treat DME with the possibility to become the standard of care for all treatment-naive DME patients.

Patrik De Haes, M.D., CEO of Oxurion, said: 'We have made significant progress in developing our DME franchise in the first half of 2020. Following the positive Phase 1 results for THR-149 in 2019, in January we announced positive and highly promising Phase 1 results with THR-687 showing that this novel pan-RGD integrin antagonist has the potential to deliver improved visual outcomes to a broad population of DME patients when compared to anti-VEGFs, the current standard of care.

We have recently started our Phase 2 study of THR-149 in patients with DME. This two-part study will first select the optimal dose of THR-149 and will then compare it with aflibercept in terms of improvements in best corrected visual acuity. This Phase 2 data is designed to support our plans to position THR-149 as the treatment of choice for the large number of DME patients who have a sub-optimal response to anti-VEGF therapy.

By successfully developing THR-149 and THR-687, two novel and complimentary drug candidates that could offer improved therapeutic options beyond anti-VGEFs, we believe we are positioned to build an industry leading DME franchise. We are confident that creating this franchise will deliver significant benefits to nearly all DME patients globally and will, in parallel, generate attractive returns for our shareholders.'

Diabetic Macular Edema - Oxurion's key focus

Diabetic macular edema (DME) is a complication of diabetes caused by fluid accumulation in the macula (central part of the retina), due to leaking blood vessels, leading to swelling of the macular area due to the increased permeability of the vessels.

DME is a result of another complication of diabetes, called diabetic retinopathy (DR), in which blood vessels in the eye are damaged, allowing fluid to escape. DR is the presence and characteristic evolution of typical retinal microvascular lesions in an individual with diabetes. DR is a chronic, progressive, sight-threatening, and life-altering disease, and is the leading cause of vision loss in working-age adults (20-65 years).

DME, which is a consequence of DR, can occur at any stage in the development of DR. More than one in three people living with diabetes will develop some form of DR in their lifetime, and a third of those will have some vision-threatening form of the disease such as DME.

DR and DME are a growing public health concern due to the rapid growth in the number of people with diabetes globally.

An estimated 37.8 million people have been diagnosed with diabetes in the United States (US), European top five countries (EU5) (France, Germany, Italy, Spain, and the United Kingdom), and Japan. If the undiagnosed population is included, the estimated number of people with diabetes in these countries increases to 61.3 million people.

The prevalence of DME was estimated to be 2.8 million people in the US, EU5 and Japan in 2019. The market value for DME treatments in these markets was estimated to be between approximately $3.4 to $3.8 billion in 2019.

The market for DME therapies is dominated by anti-VEGFs, which are the current standard of care. However, anti-VEGFs have been shown to deliver sub-optimal results in a significant portion of the patient population. Around 40% of DME patients have an unsatisfactory early visual response with anti-VEGF therapy, and in many cases anti-VEGFs fail to achieve a clinically meaningful visual improvement.

Contact:

Wouter Piepers

Tel: +32 16 75 13 10

Email: wouter.piepers@oxurion.com

About Oxurion

Oxurion (Euronext Brussels: OXUR) is a biopharmaceutical company developing next generation standard of care ophthalmic therapies, which are designed to better preserve vision in patients with diabetic macular edema (DME), the leading cause of vision loss in diabetic patients worldwide.

Oxurion is building a leading global franchise in the treatment of DME, based on the successful development of its two novel therapeutics: THR-149, a plasma kallikrein inhibitor being developed as a potential new standard of care for DME patients who respond sub-optimally to anti-VEGF therapy.

THR-149 has shown positive topline Phase 1 results for the treatment of DME. The Company is currently conducting a Phase 2 clinical trial evaluating THR-149 with DME-patients who previously responded sub-optimally to anti-VEGF therapy.

THR-149 was developed in conjunction with Bicycle Therapeutics PLC

THR-687, is a pan-RGD integrin inhibitor, that is initially being developed as a potential new standard of care for all DME patients Positive topline results in a Phase 1 clinical study assessing it as a treatment for DME were announced in January 2020. THR-687 is expected to enter a Phase 2 clinical trial by mid 2021.

THR-687 is an optimized compound derived from a broader library of integrin inhibitors in-licensed from Galapagos NV (Euronext & NASDAQ: GLPG).

Oxurion is headquartered in Leuven, Belgium, and is listed on the Euronext Brussels exchange under the symbol OXUR.

Important information about forward-looking statements

Certain statements in this press release may be considered 'forward-looking'. Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company's Annual Report. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of Oxurion in any jurisdiction. No securities of Oxurion may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. state securities laws.

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