New drug CEQUA receives FDA approval
Last Thursday, Sun Pharmaceuticals announced they had received FDA approval for CEQUA, its dry eye drug.
If you've been following the dry eye drug pipeline, you'll have known of this under the name OTX-101. It is a cyclosporine drug sporting "nanomicellar technology" (see press release below for details). 0.09% cyclosporine is a substantially higher concentration than Restasis' 0.05%. I really haven't heard a lot of talk about this one. They filed back in December on the strength of some strong 12-week clinical trial results. Their primary endpoint was Schirmer score. They are claiming fairly quick results.
Excerpt from Sun Pharma's press release:
Mumbai, India, Princeton, NJ, August 16, 2018 – Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries and/or associate companies) today announced that Sun Pharma has received approval for CEQUA (cyclosporine ophthalmic solution) 0.09%, from the U.S. Food and Drug Administration (FDA). CEQUA is indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye).
CEQUA provides the highest FDA-approved concentration of cyclosporine A (CsA) and is the first and only approved CsA product that incorporates a nanomicellar technology. The innovative nanomicellar formulation allows the CsA molecule to overcome solubility challenges, penetrate the eye’s aqueous layer and prevents the release of the active lipophilic molecule prior to penetration. In the Phase 3 confirmatory trial on CEQUA, after 12 weeks of treatment, as compared to vehicle, CEQUA 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. CEQUA is dosed twice daily and will be available as a single-use vial.