FDA panel issues two 'approvable' letters

WASHINGTON — Two devices received "approvable with conditions" letters from a Food and Drug Administration advisory panel this month. The Morcher Capsular Tension Ring for capsular bag stabilization and Paragon's rigid gas permeable lenses for orthokeratology received the approvable designation at meetings on January 17 and 18.

Capsular Tension Ring

The FDA’s Ophthalmic Devices Panel advisory committee recommended revising the indications for use of Morcher's Capsular Tension Ring (CTR) to read: "For the stabilization of the crystalline lens capsule in the presence of weak or partially absent zonules in patients aged 18 years or older."

In addition, the company must provide to the panel data on complications from its phase 1 and 2 studies, including glaucoma, uveitis, cystoid macular edema, retinal detachment, branch retinal vein occlusion, phthisis, broken eyelets and device explantation.

The device’s labeling also must be revised. New information to be added includes a statement that the endocapsular ring does not alter the progression of zonular instability over time. The panel also suggested Morcher remove several contraindications from its labeling, including progressive eye disease, glaucoma, chronic uveitis, non-proliferative diabetic retinopathy and operative complications such as prolapsed vitreous or bleeding.

Lenses for ortho-K

Paragon's CRT and Quadra gas permeable contact lenses also received an "approvable with conditions" recommendation from the panel for use in orthokeratology. The lenses are currently indicated for the temporary reduction of naturally occurring myopia from -0.5 D to -6 D of sphere with up to 1.75 D of astigmatism in an overnight wear fitting program.

Among the conditions for approval are inclusion of the phrase "in ages 18 years and older" in the indications.

The panel also made revising the labeling a condition of approval. Among the revisions: Include information that the study population was predominantly white; include discontinuation rate (34.6%) and the reasons for discontinuation; state that 10% to 15% of the study patients did not achieve 20/40 uncorrected visual acuity, with the trend worsening for higher myopic patients; and include a statement that orthokeratology does not affect the magnitude of pretreatment astigmatism.

Paragon will also need to add a caution statement that corneal edema is more prevalent with the use of the lens in high altitudes and revise its side effect data to include discomfort rates, punctate epithelial keratopathy and other clinical findings.