Veloce BioPharma is clinical stage company that has successfully completed multiple phase 2 clinical trials in dermatology for indications that include molluscum contagiosum, chemotherapy associated paronychia, and common warts with our novel antiseptic formulation. As company founders are ophthalmologists, and diseases of the eyelid and ocular surface crossover with the field of dermatology- it is a natural fit for our company to build an ophthalmology division. Our ocular drug candidate is 505 (b)2 pathway enabled and ready for phase 2 testing after the submission of an IND with the FDA.
Our founders have been involved with the chemistry of PVI for decades. Our CEO, successfully developed and sold ($300M) a PVI based formulation for the treatment of adenoviral conjunctivitis. Based on this success and a multitude of scientific publications, we believe that our novel formulation through mechanisms of penetration enhancement along with properly titrated amounts of free iodine reaching target tissues will be an effective treatment for blepharitis.
Our current hypothesis is that this formulation is a safe and effective treatment for blepharitis. Because of the long history and efficacy of our API, we are able to pursue FDA approval through the 505 (b)2 pathway. Our project will consist of two phases- the first will be the submission of the IND to the FDA. Once this is completed, we will commence Phase 2 clinical trials through the aforementioned pathway. The Phase 2 clinical trial will enroll approximately 50-100 patients in a placebo-controlled, randomized clinical trial to be conducted in the US. Primary endpoints will include global assessment scores of eyelid erythema, edema, lash debris, lash follicles, palpebral conjunctiva, and meibomian glands. Secondary endpoints will include assessment of psychometrics and microbiological parameters.