Weekly Ophthalmic Newsletter

1. FDA Approves Formycon and Klinge’s Biosimilar to Eylea?

Formycon AG and its licensing partner Klinge Pharma announced the U.S. Food and Drug Administration's (FDA) approval of FYB203/AHZANTIVE?, a biosimilar to Eylea?.

FYB203/AHZANTIVE? has been approved by the FDA for the treatment of patients with Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), and Macular Edema following Retinal Vein Occlusion (RVO).

Formycon AG and Klinge Biopharma GmbH have also submitted a marketing authorization application for FYB203 to the European Medicines Agency (EMA) in late 2023. A decision from the EMA is anticipated by early 2025 at the latest.

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2. EMA’s CHMP Issues Negative Opinion on Syfovre for GA; Apellis to Pursue Re-Examination

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency delivered a negative opinion on the marketing authorization application (MAA) for Apellis Pharmaceuticals’ Syfovre (pegcetacoplan), intended for the treatment of geographic atrophy (GA).

In their assessment, the CHMP noted, “Although the studies showed that Syfovre slowed the growth of geographic atrophy lesions, this did not lead to clinically meaningful benefits for patients.” The committee underscored the necessity for treatments to significantly impact patients’ daily lives, which they found lacking in the clinical data.

Additionally, concerns were raised over the safety profile of regular intraocular injections, highlighting risks such as the development of other forms of age-related macular degeneration (AMD) or eye inflammation that could exacerbate vision impairment.

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3. Novo Nordisk’s Popular Weight Loss Drugs Linked to Higher Risk of NAION

A recent study led by investigators from Mass Eye and Ear has found a concerning association between the use of semaglutide, prescribed for diabetes and weight loss under brand names Ozempic and Wegovy, developed by 诺和诺德 , and an increased risk of a serious eye condition known as NAION (non-arteritic anterior ischemic optic neuropathy).

The study revealed that patients with diabetes who were prescribed semaglutide were over four times more likely to develop NAION compared to similar patients not using the drug. For individuals who were overweight or obese and prescribed semaglutide, the risk of NAION diagnosis was more than seven times higher.

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4. Alcon Completes Acquisition of BELKIN Vision

Alcon has finalized its acquisition of BELKIN Vision, marking a significant expansion of its glaucoma treatment offerings. The acquisition, valued at $81M upfront, with potential additional payments up to $385M contingent on sales milestones, includes BELKIN Vision’s innovative Direct Selective Laser Trabeculoplasty (DSLT) technology.

Currently approved in the European Union (E.U.) and the United Kingdom (U.K.), DSLT has received 510(k) Clearance from the U.S. Food & Drug Administration, with plans for U.S. availability by the end of 2024. Alcon intends to integrate DSLT into its Alcon Vision Suite ecosystem, ensuring comprehensive support and training to meet the needs of healthcare providers and patients alike.

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5. Roche’s Vabysmo Receives CHMP Recommendation for RVO Indication

罗氏公司 announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the extension of marketing authorization for Vabysmo (faricimab).

This recommendation includes the treatment of visual impairment caused by macular edema secondary to retinal vein occlusion (RVO). Developed by Genentech, a member of the Roche Group, Vabysmo awaits final approval from the European Commission.

The company expects a decision from the European Commission in the near future regarding the expanded use of Vabysmo for the treatment of RVO in the European Union.

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