AUG 26, 2020
By Kanaga Rajan
Recordati Rare Diseases
Cornea/External Disease
Recordati Rare Diseases has announced FDA clearance of their cysteamine 0.37% eye drops (Cystadrops) for treating cystinosis-related corneal crystal deposits.
The first and only approved cysteamine eye drops, the viscous solution is indicated for depleting corneal cystine crystal deposits in adults and children with this rare condition. The recommended dose is 1 drop in each eye, 4 times daily.
The FDA based their decision on a pair of open-label clinical trials that comprised 23 patients. In the phase 3 trial, patients were monitored using in vivo confocal microscopy, which showed cysteamine led to a 40% improvement across all corneal layers at 90 days. Patients in the phase 1/2a adaptive dose-response trial sustained a 30% improvement for 5 years.
In both studies, the most common adverse reactions were eye pain, irritation, redness, itching, blurred vision, sticky eyes or eyelids at the instillation site, watery eyes and medicine deposits on eye lashes or around the eyes. Since the eye drops contain the preservative benzalkonium chloride, the company recommends contact lens wearers wait 15 minutes after administration before inserting contact lenses.
Cystadrops is already available in Europe since its EMA approval in 2017.