Steroid eye drops are widely used for the treatment of pain and inflammation following ocular surgery and other inflammatory ocular conditions. Variety of ocular steroids in the form of suspension, gels and emulsions are available in market. However, they need to be administered 3-4 times a day. These formulations may also cause blurring of vision and unease to the patients.

To overcome these shortcomings, SPARC is developing SDN - 037 with the aim of improving dosing and patient convenience. It is a novel optimized formulation of an approved ocular steroid. SDN - 037 eye drops are formulated at a lower strength and are intended to be used twice a day instead of 4 times a day. Moreover, SDN - 037 is clear colourless solution instead of white hazy eye drops. SPARC has developed novel technology for delivery of ocular steroids that uses non-ionic, cationic and anionic solubilizers to provide a unique nanometre sized micelle with neutral surface property. Steroid is entrapped inside the tiny micelle structure that looks transparent to the eye. The polymeric components further stabilise the micellar system and also provide enhanced bio adhesion, retention and corneal permeation.

SDN - 037 IND has been granted by USFDA in Q2 FY19. Phase 3 study has been initiated in Q1 FY19 with target enrolment of 386 subjects and at ~15 sites across US. NDA submission is planned by Q2 FY20.