Preservative-free Bimatoprost Gel Gains FDA Approval

An FDA trial found Zolymbus noninferior to preserved bimatoprost. Thea Pharma will differentiate the product based on its favorable patient tolerability due to the preservative-free formulation. Glaucoma patients on chronical topical medication regimens are often subjected to ocular surface compromise brought on by repeat exposure to the BAK preservative in many eye drops. To help, a new preservative-free therapy called Zolymbus (bimatoprost 0.01%) was just appproved for use in glaucoma patients and ocular hypertensives. It will be marketed by Thea Pharma, a longtime advocate of preservative-free approaches to treatment.The company’s marketing materials state that the gel’s carbomer base gives it mucoadhesive properties that increase ocular surface contact time to support penetration and drug delivery.A 12-week trial comparing Zolymbus to a preserved formulation of bimatoprost 0.01% found the gel to be noninferior, leading to FDA approval. Intended use is one administration from the product’s single-use vials at bedtime.Visit https://zolymbus.com for more information.