Weekly Ophthalmic Newsletter

1. FDA Approves Apellis' Syfovre as First and Only Treatment for Geographic Atrophy

The FDA has approved Apellis Pharmaceuticals'?Syfovre (pegcetacoplan)?for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). This marks the first time that patients with GA have an FDA-approved treatment option, which is a significant milestone in medical history.

Syfovre is expected to be available in the US by the beginning of March through specialty distributors and specialty pharmacies nationwide.

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2. FDA Accepts Orasis Pharmaceuticals' NDA for CSF-1 for Treatment of Presbyopia

Orasis Pharmaceuticals announced that the FDA has approved the company's new drug application (NDA) for investigational?CSF-1 (low dose pilocarpine hydrochloride 0.4%)?for review. A Prescription Drug User Fee Act (PDUFA) goal date of October 22, 2023 has been set by the FDA.

CSF-1 is a preservative-free, proprietary formula that contains a low dosage of pilocarpine and a multifaceted vehicle. It is intended to strike the right balance between effectiveness, safety, and comfort. By modulating the pupil, CSF-1 enhances near visual acuity, resulting in a "pinhole effect" that increases depth of field and improves the ability to concentrate on close-up items.

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3. UVA Researchers Discover Potential New Way to Prevent Vision Loss

Researchers at UVA Health have discovered a new cause of harmful blood vessel growth in the eye that could pave the way for the development of new treatments for macular degeneration and other common causes of vision loss.

The team has identified a new target that could be used to prevent the formation of abnormal tangles of blood vessels, which are linked to eye conditions like neovascular age-related macular degeneration, proliferative diabetic retinopathy, and ischemic retinal vein occlusion.

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4. FDA Extends Warning on Eye Care Products to Include Delsam Pharma's Artificial Eye Ointment

The FDA has issued a warning to consumers and healthcare professionals not to purchase or use Delsam Pharma's Artificial Eye Ointment due to potential bacterial contamination. This eye oinment is an over-the-counter product, intended to be sterile and produced by?the recalled EzriCare Artificial Tears’?manufacturer, Global Pharma Healthcare Private Limited. The company agreed to initiate a recall.

The FDA has faulted the company for numerous violations and has prohibited the import of the company's items into the United States, CBS News reported on the matter.

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5. European Parliament Extends MDR Compliance Timeline to 2027-2028

The European Parliament voted in favor of delaying the implementation of the new Medical Device Regulation (MDR) and approved the European Commission's plan, which was adopted in January. The plan involves extending the deadlines for compliance with the new certification rules for medical devices, with the timeline varying based on the risk class of the device.

This measure aims to guarantee patients' continuous access to medical technologies. The European Commission also stated that devices that were placed on the market under the existing legal framework can still be sold.

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