Weekly Ophthalmic Newsletter

1. Stem Cell Therapy Restores Cornea Damage in Phase I Trial

A team led by researchers from Mass Eye and Ear, a member of Mass General Brigham, reports the results of a phase I trial of a revolutionary stem cell treatment called cultivated autologous limbal epithelial cell transplantation (CALEC), which was found to be safe and well-tolerated over the short term in four patients with significant chemical burns in one eye.

While the phase I study was designed to determine preliminary safety and feasibility before advancing to a second phase of the trial, the researchers consider the early findings promising.

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2. Nanoscope's MCO-010 Shows Notable Improvement in Vision Function for Stargardt Disease

Nanoscope Therapeutics announced significant findings from its Phase 2 clinical trial, STARLIGHT, during the annual meeting of the American Society of Retina Specialists (ASRS) in Seattle last week.

Key Highlights from the STARLIGHT Clinical Trial:

● Patients administered with MCO-010 exhibited noteworthy improvements in best-corrected visual acuity (BCVA).

● An estimated gain of around 3 dB was recorded in mean sensitivity, as evaluated by Octopus visual field perimetry.

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3. FDA Warns of Methylsulfonylmethane Eye Drops Due to Contamination

The FDA has issued warning to consumers, advising them against purchasing and immediately discontinuing the use of two products: Dr. Berne's MSM Drops 5% Solution and LightEyez MSM Eye Drops – Eye Repair. The warning is based on the potential presence of bacterial contamination, fungal contamination, or both, in these products.

These particular items are manufactured by two companies: Dr. Berne’s Whole Health Products distributes Dr. Berne’s products, while LightEyez Limited distributes LightEyez’ products.

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4. Scientists Develop Novel Therapeutic Model to Treat Incurable Eye Diseases

In a study published as a Reviewed Preprint in eLife, researchers have effectively transplanted human microglia cells into the mouse retina. This innovative model holds promise for testing novel treatments targeting incurable eye diseases.

The editors have deemed this research significant, showcasing robust data that underscores the potential of microglial replacement therapy in addressing retinal and central nervous system ailments.

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5. Apellis Identifies Potential Cause of Rare Safety Events with Syfovre

Apellis Pharmaceuticals has identified a potential link to the?rare cases of retinal vasculitis observed?in real-world use of its newly approved GA treatment,?Syfovre.

As part of the investigation into these safety events, the company pinpointed "internal structural variations" in the particular 19-gauge x 1? inch filter needle present in specific injection kits.?Apellis suggests that healthcare professionals immediately discontinue the use of injection kits containing the 19-gauge filter needle and instead use kits with the 18-gauge filter needle.

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