Peter Sallstig, MD, MBA, is the chief medical officer (CMO) and global head of the product development division at Santen, a 133-year-old company dedicated to ophthalmology that conducts research, development, marketing and sales of pharmaceuticals, over-the-counter products and medical devices. Dr. Sallstig joined the company in 2018 and has more than 20 years of experience in the pharmaceutical industry at national and international levels, across large multinationals and small biotechs that include Novartis, BMS, Alcon and Insmed.

Ophthalmology Management: Can you discuss your role as CMO at Santen and how you got started in this role? Why did you move in this direction with your career and how?

Dr. Peter Sallstig: As CMO, I work with others to expand Santen’s products and to make them available to our patients and physicians worldwide. It is a great opportunity to lead the organization, both from early stages such as non-clinical all the way into late stage, which includes global medical affairs, global regulatory affairs, global safety vigilance, project management, etc. This role was a natural progression in my career as I have always been compelled to serve patients in need and truly enjoy pushing the scientific boundaries on how to get us to it.

As MDs, we are trained early on to be accountable, to rise to the occasion when it’s needed and to find better and innovative solutions for our patients. Serving as CMO is really a culmination from that. I am really thrilled about this opportunity to guide the organization as CMO.

OM: Last year, Santen and UBE received FDA approval for OMLONTI (omidenepag isopropyl ophthalmic solution) 0.002% for the reduction of elevated IOP in patients with primary open-angle glaucoma or ocular hypertension. How does it work?

PS: OMLONTI is developed jointly by Santen and UBE Industries. Omidenepag isopropyl, the active pharmaceutical ingredient in OMLONTI, is a relatively selective prostaglandin EP2 receptor agonist, which increases aqueous humor drainage through the conventional (or trabecular) and uveoscleral outflow pathways. It is the first product with this pharmacological action. We are pleased to provide doctors and patients in the United States with a new option to help control IOP and believe it will benefit many patients.

OM: Last year, Verkazia (cyclosporine ophthalmic emulsion) 0.1% was released in the United States for the treatment of vernal keratoconjunctivitis in children and adults. How does it work?

PS: Verkazia is the first FDA-approved topical immunomodulator for the treatment of vernal keratoconjunctivitis in children and adults. Administered as an eyedrop, Verkazia is a prescription-only, cationic nanoemulsion that provides improved ocular bioavailability of cyclosporine. Verkazia is thought to act by blocking release of pro-inflammatory cytokines that can cause the allergic inflammation of the ocular surface. Prior to Verkazia, many of these patients were treated with steroids. While steroids are very effective, there are some significant long-term side effects such as the occurrence of glaucoma.

OM: What other products/developments are in the pipeline at Santen for the US market?

PS: Santen is currently developing sepetaprost (DE-126), a once a day prostaglandin eyedrop with a novel mode of action that is both an FP- and EP- receptor dual agonist for the treatment of ocular hypertension and glaucoma. In a recent Phase 2b trial where we compared DE-126 vs timolol b.i.d., we were able to demonstrate not only statistical non-inferiority at all timepoints, but IOP was shown to be statistically lower than that with timolol at certain timepoints.

Santen, in collaboration with ActualEyes Inc., is also conducting a clinical trial for the global development of sirolimus eyedrops to treat Fuchs’ endothelial corneal dystrophy (FECD). Currently, the only therapy for treating FECD is the transplantation of a donor cornea. Sirolimus could provide a novel alternative treatment to a corneal transplant and may reduce the percentage of patients who develop visual impairment.

Finally, Santen is also exploring the field of refractive errors and is conducting studies for myopia and presbyopia. OM