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Proper screenings, treatment, management needed for this increasingly prevalent disease.

PDR: public health considerations  

The patient’s ocular history was significant for severe nonproliferative diabetic retinopathy (NPDR) in the right eye (OD) and mild NPDR in the left eye (OS), which had been diagnosed 4 years previously at his last eye exam. 

Case study:  Patient presents with severe PDR history 

Patient Case 2: Reversal of Contact Lens Intolerance in a Young Patient Following Demodex Blepharitis Treatment

A panelist discusses how treating Demodex blepharitis led to successful reversal of contact lens intolerance in a young patient, highlighting the importance of addressing underlying ocular surface conditions.

Video Series

Patient Case 1: Delaying Cataract Surgery to Prioritize Aggressive Treatment of Ocular Surface Disease, Including Demodex Blepharitis

A panelist discusses how prioritizing aggressive treatment of ocular surface disease, particularly Demodex blepharitis, before proceeding with cataract surgery can lead to better surgical outcomes and patient satisfaction.

Preoperative Ocular Surface Disease Algorithm Overview

A panelist discusses how evaluating and treating ocular surface disease before cataract or refractive surgery through a systematic algorithm improves surgical outcomes and patient satisfaction.

This poll is for optometrists and eyecare professionals, only. It will close on Friday, November 5, 2021.

Poll: What pipeline presbyopia treatment are you most looking forward to?

-In the midst of its contentious merger offer from Novartis, Alcon Inc. announced it will acquire the rights to three products from Tampa, FL-based Sirion Therapeutics Inc. 

On Jan. 18, Alcon said it would acquire the U.S. rights to two FDA-approved products-difluprednate ophthalmic emulsion (Durezol) 0.05%, an ophthalmic corticosteroid in drop form for the treatment of inflammation and pain associated with eye surgery, and ganciclovir ophthalmic gel 0.15% (Zirgan), which the FDA approved on Sept. 17 for treating acute herpetic keratitis. In April 2007, the FDA had granted the gel orphan drug status. 

The acquisition also gives Alcon nearly global rights, excluding Latin America, to cyclosporine (Zyclorin), an investigational drug being developed to treat dry eye and other ocular surface diseases. The deal is expected to close by the end of Q1 2010, and hinges on customary closing conditions and required regulatory approvals. 

"While the potential Novartis deal is certainly an issue for us, our leadership is focused more on continuing to build Alcon's commercial capabilities and research pipeline," MacHatton said. "The Sirion deal is a good example of that, as it brings a currently marketed product in Durezol, the recently approved orphan drug Zirgan that will be launched soon, and a potential dry-eye treatment for our pipeline." 

MacHatton declined to say the cost of the acquisitions. 

Sirion spokeswoman Erin Parsons said the deal is "totally separate" from Alcon's discussions with Novartis. "We are certain this will not affect the completion of the deal between Alcon and Sirion," she said. 

In the midst of the contentious merger offer from Novartis, Alcon Inc. announced it will acquire the rights to three products from Tampa, FL.-based Sirion Therapeutics Inc.

Alcon acquires rights to three Sirion products

A large international study conducted by the LHON Study Group reported that a unilaterally administered gene therapy to treat Leber hereditary optic neuropathy (LHON) caused by the 

gene variant resulted in bilateral improvement in visual acuity with improved quality of life and good overall tolerability up to 5 years after treatment.

The first study author, Patrick Yu-Wai-Man, MD, PhD, and colleagues commented, “These results demonstrated the persistent benefit over time from 1 dose of lenadogene nolparvovec (rAAV2/2-ND4, Lumevoq, GenSight Biologics SA), which is promising for the use of gene therapy in LHON due to the 

gene variant,” the most common cause of LHON.

Yu-Wai-Man is from the Cambridge Centre for Brain Repair and MRC Mitochondrial Biology Unit, Department of Clinical Neurosciences, University of Cambridge, and the Cambridge Eye Unit, Addenbrooke’s Hospital, Cambridge University Hospitals, both in Cambridge, United Kingdom; and Moorfields Eye Hospital, and the Institute of Ophthalmology, University College London, both London.

LHON, a genetic disease that affects the retinal ganglion cells,

results in severe bilateral sequential vision loss.

The investigators explained, “Lenadogene nolparvovec, an adeno-associated virus (AAV)–based ocular gene therapy, was developed to treat patients carrying the m.11778G>A mitochondrial DNA gene variant. Its efficacy and safety have been evaluated in four clinical studies that showed an improvement in best-corrected visual acuity (BCVA) up to 2 years after administration and a good safety profile.

The multinational, multicenter, prospective RESTORE Study is the 5-year follow-up study of the phase 3 clinical RESCUE and REVERSE Studies of lenadogene nolparvovec to treat vision loss from LHON due to the 

 mutation. The RESCUE Study evaluated the treatment up to 6 months after the onset of LHON

 and the REVERSE Study did the same from 7 months to 1 year.

In the RESCUE and REVERSE Studies, the patients were treated with a intravitreous injection in 1 eye and a sham injection in the other eye. The main outcome measures were the best-corrected visual acuity (BCVA), quality of life using the National Eye Institute visual functioning questionnaire 25, and adverse events.

The RESTORE Study included 62 of 76 patients who were included in the RESCUE ad REVERSE Studies; 55 patients completed the 5-year examination. The investigators reported that the patients “sustained bilateral improvement in visual acuity with improved quality of life and good overall tolerability up to 5 years after unilateral lenadogene nolparvovec intravitreal administration in patients with LHON due to the 

The investigators concluded, “In this analysis of the RESTORE trial, the follow-up of patients with LHON due to the 

 gene variant unilaterally treated with lenadogene nolparvovec demonstrated a sustained bilateral improvement in BCVA and a good safety profile up to 5 years after treatment. This evidence of persistent benefit over time is promising for the use of gene therapy in these patients.”

Yu-Wai-Man P, Newman NJ, Biousse V, et al. Five-year outcomes of lenadogene nolparvovec gene therapy in LHON. 

Published online December 19, 2024. doi:10.1001/jamaophthalmol.2024.5375

Yu-Wai-Man P, Griffiths PG, Chinnery PF. Mitochondrial optic neuropathies—disease mechanisms and therapeutic strategies. 

Vignal-Clermont C, Girmens JF, Audo I, et al. Safety of intravitreal gene therapy for treatment of subjects with Leber hereditary optic neuropathy due to mutations in the mitochondrial ND4 gene: the REVEAL study. 

Newman NJ, Yu-Wai-Man P, Carelli V, et al.; LHON Study Group. Efficacy and safety of intravitreal gene therapy for Leber hereditary optic neuropathy treated within 6 Months of disease onset. 

Yu-Wai-Man P, Newman NJ, Carelli V, et al. Bilateral visual improvement with unilateral gene therapy injection for Leber hereditary optic neuropathy. 

Newman NJ, Yu-Wai-Man P, Subramanian PS, et al.; LHON REFLECT Study Group. Randomized trial of bilateral gene therapy injection for m.11778G>A MT-ND4 Leber optic neuropathy. 

Autumnn Wooten, OD

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