Catch up with what Optometry Times shared this week:

US FDA issues Complete Response Letter for avacincaptad pegol (IZERVAY)

By Hattie Hayes and Jordana Joy, Associate Editor

Astellas Pharma Inc. announced the United States Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for avacincaptad pegol intravitreal solution (IZERVAY). In the November 15 CRL, the FDA stated it cannot approve a supplemental New Drug Application in its present form. IZERVAY had an expected Prescription Drug User Fee Act (PDUFA) date of November 19.¹

In a press release, Astellas noted that the FDA comments in the CRL were not related to the safety, efficacy or risk of use for IZERVAY. The lack of approval is instead related to a statistical matter pertaining to proposed labelling language for the product.

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Aldeyra Therapeutics announced NDA acceptance for reproxalap for dry eye, expansion of exclusive option agreement

By Emily Kaiser Maharjan, Assistant Managing Editor

The FDA has accepted the resubmitted new drug application (NDA) from Aldeyra Therapeutics for its first-in-class investigational candidate, topical ocular reproxalap for the treatment of signs and symptoms of dry eye disease. At the same time, Aldeyra is choosing to expand their option agreement with AbbVie, granting the manufacturer more cash to bring the drug to market.1

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Wait, this is not allergies: Case report on carotid-cavernous fistula

By Shawna L. Vanderhoof, OD, FAAO

Although conjunctival redness and eyelid swelling can affect vision and comfort, they are also unsightly, giving the patient a sense of urgency to resolve the condition as soon as possible. As patients often do, I googled “swollen eyelid,” and the results list the common, possible causes such as allergies, blepharitis, styes, or pink eye (which is such a catch-all term). Recommended remedies include a cold compress or tea bag and lubricating eye drops, which should resolve the problem in a day.

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AAOpt 2024: Simplifying genetic testing

By Mohammad Rafieetary, OD, FAAO, FORS, Dipl ABO, ABCMO, and Jordana Joy, Associate Editor

Mohammad Rafieetary, OD, FAAO, FORS, Dipl ABO, ABCMO, discusses one of his presentations, "Suprachoroidal Delivery of Investigational ABBV-RGX-314 Gene Therapy for Diabetic Retinopathy: The Phase II ALTITUDE Study," which he gave alongside Roya Attar, OD, MBA, DHA at the AAOpt 2024 conference.

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Study: Long-term blood pressure variability and visual field progression in glaucoma

By Lynda Charters

A newly published study¹ reported that higher mean blood pressure (BP) levels and higher standard deviation (SD) of BP are associated with faster progression of visual field (VF) defects in patients with glaucoma.

Vincent Q. Pham, BS, and colleagues from the Viterbi Family Department of Ophthalmology, Hamilton Glaucoma Center, Shiley Eye Institute, University of California, San Diego, La Jolla, CA, reported their results in JAMA Ophthalmology.

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