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FDA Approvals Reshape Ophthalmology in 2023: A Year of Transformative Advances

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In the field of ophthalmology, the year 2023 saw a remarkable transformation with the FDA granting approvals for a total of 12 significant advancements. As we wrap up the year, there’s a promising pipeline of drugs, setting high expectations for continued progress in ophthalmological care in 2024 and beyond.

2023 was an exceptional year for ophthalmology, witnessing a total of 12 FDA approvals, marking significant strides in the field. In addition to these approvals, several companies received complete response letters (CRL) from the FDA. Reflecting on the year and its numerous achievements, Peter J. McDonnell, MD, director of the Wilmer Eye Institute and chief medical editor of Ophthalmology Times, remarked, “I think there has never been a better time to be an ophthalmologist.”

Major FDA Approvals Reshaping Ophthalmology in 2023

The year started on a strong note with the FDA approval of Apellis’ pegcetacoplan injection (Syfovre) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). This marked a significant milestone as the first and only FDA-approved treatment for GA. The availability of this therapy holds immense implications for addressing unmet needs among a large patient population and presents challenges for healthcare payors, especially Medicare.

Subsequently, Astellas Pharma secured FDA approval for avacincaptad pegol intravitreal solution (Izervay) in August, following their acquisition of Iveric Bio in July. Notably, the year began without any FDA-approved treatments for GA, and by the end of the year, there were two, with numerous others in development globally. Regeneron also made a significant contribution in February with the FDA approval of aflibercept (Eyelea) injection for the treatment of retinopathy of prematurity (ROP) in preterm infants. This marked a pivotal moment, offering an alternative to the complex and stressful laser photocoagulation procedure previously used for these infants.

Advancements and Challenges in Ophthalmology

Later in the year, Regeneron obtained FDA approval for aflibercept 8 mg (Eyelea HD) for the treatment of wet AMD, diabetic macular edema (DME), and diabetic retinopathy (DR), based on the results of the PULSAR and PHOTON trials. Bausch + Lomb also joined the ranks with the FDA approval of perfluorohexyloctane ophthalmic solution (MIEBO) for the treatment of dry eye disease (DED) in May, marking the first FDA-approved treatment targeting tear evaporation for DED.

Eyenovia made a groundbreaking achievement with the FDA approval of MydCombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5%, the first fixed-dose combination of tropicamide and phenylephrine in the US. Eyenovia’s proprietary Optejet device was also approved for the first time by any regulatory authority.

Despite these successes, the year was not without its challenges, as seen with complete response letters issued to Aldeyra Therapeutics for ADX-2191 (methotrexate for injection) and reproxalap, both aimed at treating different aspects of eye health. Novaliq achieved FDA approval for Vevye (cyclosporine ophthalmic solution) 0.1% in November, offering an effective treatment for the signs and symptoms of DED. Tarsus Pharmaceuticals Inc. earned recognition for its lotilaner ophthalmic solution 0.25% (Xdemvy) to treat Demodex blepharitis, becoming the first FDA-approved treatment targeting Demodex mites.


FDA Approvals/Challenges and the Future of Ophthalmology

However, the FDA also issued a complete response letter to Sun Pharma Advanced Research Company (SPARC) for PDP-716 (brimonidine tartrate 0.35%), citing inspection findings at a third-party Active Pharmaceutical Ingredient (API) manufacturing facility. This decision did not raise concerns about the drug’s clinical efficacy or safety. The year concluded with Outlook Therapeutics receiving a complete response letter for Lytenava, an investigational ophthalmic formulation of bevacizumab for the treatment of wet AMD and other retinal diseases. Despite these setbacks, anticipation for the future remains high, with numerous drugs in the pipeline for 2024 and beyond.

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2023 undoubtedly stands as a monumental year in ophthalmology, marked by a dozen FDA approvals that reshaped the landscape of eye care. It also highlighted the challenges and rigorous standards upheld by regulatory authorities. As we enter 2024, the field is poised for continued progress, with promising developments such as APP13007 (clobetasol propionate ophthalmic nanosuspension) and NVK002 (low dose atropine), underscoring the relentless pursuit of advancements in ophthalmological care.


Resource: Opthalmology Times, December 12, 2023

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