Solution for Treating Dry Eye Disease Approved by FDA

Sun Pharmaceutical's cyclosporine ophthalmic solution is the first and only dry eye treatment to combine cyclosporine A with nanomicellar technology, according to the company.

A cyclosporine ophthalmic solution (Cequa, Sun Pharma) for treating dry eye disease has been approved by FDA officials, according to a press release. The newly approved product (0.09%) is indicated to increase tear production in patients with dry eye.

According to Sun Pharma, the solution contains the highest FDA-approved concentration of cyclosporine A (CsA). Cequa also is the first dry eye treatment to combine cyclosoporine A with nanomicellar technology, the company said, in a prepared statement announcing the FDA approval.

Cequa is dosed twice daily, and will be available as a single-use vial, according to Sun Pharma. The nanomicellar formulation allows the CsA molecule to overcome solubility challenges, penetrate the eye’s aqueous layer, and prevent the release of the active lipophilic molecule prior to penetration.

The Phase 3 confirmatory trial on Cequa studied 744 patients with dry eye. After 12 weeks of treatment, as compared to vehicle, the solution showed statistically significant improvement in the primary endpoint, Schirmer’s score (a measurement of tear production) (p<0.01). Improvements in secondary endpoints (i.e. ocular staining assessments) were seen as early as 1 month after initiating treatment.

“Dry eye is a complex disease that lacks a ‘one-size-fits-all’ approach. As a clinician treating a high volume of dry eye patients, it’s important to have multiple treatment modalities available at my disposal,” said Jodi Luchs, MD, the principal investigator behind the Cequa confirmatory Phase 3 trial, in a prepared statement. “Given its strong clinical trial performance, the approval of Cequa is welcomed news, and I look forward to offering my patients this compelling new option.”

Cequa’s nanomicellar formulation technology utilizes micelles, which are gelatinous aggregates of amphipathic (both hydrophobic and hydrophilic) molecules formed at a well-defined concentration. The small size of the nanomicelles facilitates entry into corneal and conjunctival cells, enabling delivery of high concentrations of CsA.

In a prepared statement Abhay Gandhi, CEO, North America, Sun Pharma, said Cequa delivers a lipophilic molecule in a clear solution form with novel nanomicellar formulation. for a proven dry eye medication.

“Dry Eye Disease represents an area of high unmet medical need, with a significant number of patients who are currently untreated,” said Gandhi, in the statement. “The U.S. FDA approval of Cequa represents a long-awaited dry eye treatment option and is an important milestone in the development of Sun’s Ophthalmics business.”

According to Sun Pharma, reported adverse effects were mild to moderate. The most common adverse reaction following the use of cyclosporine ophthalmic solution 0.09% was instillation site pain (22%), and conjunctival hyperemia (6%). Other adverse effects, reported in 1% to 5% of the patients studied, were eye irritation, blepharitis urinary tract infection, headache, and bronchitis.

Reference

Sun Pharma Announces U.S. FDA Approval of CEQUATM to Treat Dry Eye Disease [news release]. Mumbai, India and Princeton, NJ: Sun Pharmaceutical Industries; August 16, 2018. https://cequapro.com/pdf/cequa-news-release.pdf.