Week in Review - November 12, 2023

Welcome to another edition of the Ophthalmology Times EyePod Week in Review podcast, a recap of some of the week’s top headlines.

FDA issues warning letter to Amazon for selling unapproved eye care products

In a letter addressed to Andrew Jassy, President and CEO of Amazon, the FDA issued a warning to the company regarding the sale of unapproved ophthalmic drugs.

Recently, the FDA urged customers to avoid several eyedrops due to the possible risk of eye infections that could result in vision loss or blindness. This is just one of many times the FDA has issued a warning on unapproved ophthalmic products in 2023.

The letter specifies 7 drugs that Amazon is “responsible for introducing or delivering for introduction into interstate commerce” which are “unapproved new drugs under section 5 0 5 (a) of the Federal Food, Drug, and Cosmetic Act.

The list of ophthalmic drops included in the letter are:

• Similasan Pink Eye Relief
• The Goodbye Company Pink Eye
• Can-C Eye Drops
• Optique 1 Eye Drops
• OcluMed Eye Drops
• TRP Natural Eyes Floaters Relief
• Manzanilla Sophia Chamomile Herbal Eye Drops

In the letter, the FDA warns Amazon that these products are especially concerning because “ophthalmic drug products, which are intended for administration into the eyes, in general, pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.”

Atsena Therapeutics receives FDA Regenerative Medicine Advanced Therapy designation for ATSN-101

Atsena Therapeutics announced the US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy designation to ATSN-101, the company’s lead investigational gene therapy for patients with Leber congenital amaurosis caused by biallelic mutations in GUCY2D.

According to the company, the RMAT designation was granted based on positive 6-month efficacy data from the company’s ongoing Phase I/II clinical trial of ATSN-101.

Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the drug development and review processes for promising pipeline products, including gene therapies.

A regenerative medicine therapy is eligible for RMAT designation if it is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug or therapy has the potential to address unmet medical needs for that disease or condition.

Tarsier Pharma holds Type C meeting with FDA for TRS01 in noninfectious uveitis

Tarsier Pharma Ltd announced the successful outcome of a Type C meeting with the FDA, supporting the advancement of TRS01 eye drop formulation for the treatment of noninfectious uveitis into a registrational program based on the recently completed TRS4 Vision trial.

According to the company, the Type C meeting was supported by results from the previously completed TRS4 Vision trial – a randomly assigned, double-masked, active-controlled Phase 3 trial that was designed to evaluate the efficacy and safety of TRS01 eye drop formulation in noninfectious uveitis patients including uveitic glaucoma patients.

In the TRS4 Vision trial, TRS01 was found to be active in clearing inflammation, reducing ocular pain and exhibited a compelling risk/benefit profile, minimizing the concerns of IOP increase during the course of treatment

Ocugen doses first patient in Phase 1/2 clinical trial evaluating safety, efficacy of OCU410S T for Stargardt disease

Ocugen Inc announced the first patient has been dosed in its Phase 1/2 GARDian clinical trial for OCU410ST, a modifier gene therapy candidate being developed to treat Stargardt disease.

Stargardt disease is a genetic eye disorder that causes retinal degeneration and vision loss, and is the most common form of inherited macular degeneration. The progressive vision loss associated with Stargardt disease is caused by the degeneration of photoreceptor cells in the central portion of the retina called the macula.

The company also noted decreased central vision due to loss of photoreceptors in the macula is the hallmark of Stargardt disease. Some peripheral vision is usually preserved.

The disease typically develops during childhood or adolescence, but the age of onset and rate of progression can vary. The retinal pigment epithelium, a layer of cells supporting photoreceptors, is also affected in people with Stargardt disease.

According to the company, the Phase 1/-2 trial will assess the safety of unilateral subretinal administration of OCU410ST in subjects with Stargardt Disease and will be conducted in two phases. Phase 1 is a multicenter, open-label, dose ranging study. Phase 2 is a randomized, outcome accessor-blinded, dose-expansion study in which adult and pediatric subjects will be randomized in a 1:1:1 ratio to either one of two OCU410ST dose groups or to an untreated control group.

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