Industry Insider is a timely chat with an ophthalmic industry thought leader.

Kamran Hosseini, MD, PhD

Kamran Hosseini, MD, PhD, is co-founder and CEO of Surface Ophthalmics, which was created in 2018. Dr. Hosseini also led the approval process for therapies such as BromSite (Sun Ophthalmics) and AzaSite (Akorn) in addition to serving in leadership roles at companies such as Johnson & Johnson Vision and InSite Vision. Surface Ophthalmics has three clinical programs currently in development, all of which use its Klarity delivery system. The therapy furthest in development is SURF-201, to treat postoperative pain and inflammation following ocular surgery. Also in development are SURF-100, for chronic dry eye disease, and SURF-200, for acute dry eye.

Ophthalmology Management: Can you explain how the Klarity system works?

Kamran Hosseini, MD, PhD: The Klarity delivery vehicle, which contains chondroitin sulfate and was developed by Richard Lindstrom, MD, is one of the key building blocks that we use at Surface Ophthalmics. We use it to create therapeutics to relieve pain, inflammation and irritation, while protecting the ocular surface. It offers a unique and soothing lubricant that enhances patient comfort and increases contact time for active ingredients.

What this means to us is that Klarity offers the opportunity to improve patient outcomes when paired with active therapeutics as well as improve the patient experience by providing comfort and relief to patients dealing with ocular conditions or following ocular surgery.

OM: SURF-201 would be the first betamethasone-based offering for ophthalmic use in the US market. What is the significance of this for doctors and patients?

KH: Betamethasone, another one of Surface Ophthalmics’ key building blocks, offers a new corticosteroid option for the US ophthalmic market. It has a high level of potency along with a great safety record in global use; it also demonstrated rapid onset of action in our first Phase 2 clinical trial. Additionally, it is the highest ophthalmic concentration tested globally.

SURF-201 also utilizes betamethasone in the first non-preserved unit dose steroid. This means improved patient comfort and better protection for the ocular surface.

OM: Positive topline results for SURF-201 were published earlier this year. Could you briefly explain those results and tell us what’s the next step for SURF-201?

KH: We were thrilled with the results from our Phase 2 trial for SURF-201.

SURF-201 met the primary endpoints of complete clearance of anterior chamber cells, which is a marker for inflammation, at both day 8 and day 15 with p-values of 0.01 and 0.001, respectively.

While SURF-201 was dosed at only twice per day, a significantly higher percentage of patients were inflammation free by the end of the dosing when compared to the previously reported results of all other branded corticosteroids, some of which required more frequent dosing. Importantly, in addition to inflammation, when looking at the secondary endpoint, almost 90% of patients were pain free at day 15.

Overall, SURF-201 was found to be safe and well-tolerated, and there was zero incidence of IOP increase of more than 10 mm Hg from the base and exceeding the 22 mm Hg mark.

We plan to conduct our pivotal Phase 3 trials after the completion of our next FDA meeting, which will help guide us in planning appropriately for this project. We also feel that the results from the SURF-201 trial are a positive indication for our other clinical trials since we utilize similar building blocks across our therapies. So, we’re looking forward to the results from the Phase 2 trials for SURF-100 and SURF-200, which were recently initiated. OM