Keratoconus – Rare? Not really!

The Keratoconus market will be dominated by lenses, cross-linking procedures as well as IVMED-80, if approved in the coming decade.

Keratoconus, away from the general perception of a rare disease, has come a long way. Thirty-four years back, in Minnesota, United States, this disease was claimed as rare, which created a gap in disease understanding; however, this disparity has evolved dramatically with time. Since the 90s, the advancement in diagnostic tools such as corneal topography has soared the diagnosis rate at a commendable rate. The improvement, recognition, and research progress has made the disease well-known. Moreover, DelveInsight estimates the number to be 1,700,658 in the Seven Major Markets (7MM) in the year 2020.

As, at present, most of the Pharma giants consider this disease as rare; there is often a debate on the understanding of the actual prevalence of the disease. However, 612,938 diagnosed cases in the United States make us believe that it is not the case anymore. Keratoconus awareness has prompted significant development of new and improved interventions that augment the established legacy treatments.

There is a dearth of significant and up-to-date understanding of epidemiology trends in the 7MM. Nationwide Registration Study in the Netherlands recently conducted a study on a large patient pool, wherein the diagnosed keratoconus prevalence was on a much higher side as compared to any of the previous studies conducted in the European population. This study proved to be a game-changer in proving keratoconus to be much more prevalent than before. This prevalence is highly variable when it comes to different geographies worldwide due to the varying environmental and genetic factors, which account for greater prevalence of keratoconus in Asian individuals compared with whites. It is quite common in countries such as Saudi Arabia, India, Iran, Pakistan, as compared to colder regions such as Finland, Denmark, Minnesota, Japan, and Russia.

As far as the treatment is concerned, the procedures such as Intracorneal ring segment implants, Keratoplasty, Corneal Crosslinking’sapart from oral steroids, or anti-inflammatory medications—given for pain relief during the procedures—occupies the current market. Cross-linking with Riboflavin solutions in the presence of UV light is the most trending treatment option in the United States after Avedro’s Photrexa Viscous and Photrexa with the KXL System that was launched in 2016 by the USFDA for the treatment of progressive KC and corneal ectasia following refractive surgery. These cross-linking procedures have already created a negative impact on the Keratoplasty Market for the past few years, which might further reduce the transplant events in the coming years.

Furthermore, the cross-linking procedures occupied the European market much before its approval from the US FDA, as CE Marked Products had already laid grounds in Europe. Avedro, at present, holds the maximum number of CE marked products worldwide with a rapid and dramatic increase in access to these patients.

Besides, players such as Sooft Italia, Peschke Meditrade GmbH, and Lightmed-OptiMed are offering other high-quality riboflavin solutions that are being used for the treatment of progressive keratoconus in different parts of the world, especially in Europe.

The only bright spot in the otherwise bleak pipeline is Iveena Delivery System’s IVMED-80, twice-daily eye drops in Phase I/II trial for the treatment of keratoconus.

What is so unique about this eye drop? Its copper-based formulation, which is reportedly the first eye drop designed to treat keratoconus without the need for adjunctive laser treatment or surgical intervention. If approved, the eye drop is expected to target the most neglected mild and moderate patient population, for which there are no medications approved until now.

For decades, this patient pool is being taken care of with spectacle and lenses only, but it cannot stop the disease progression for a very long time.

Considering the unmet need of a neglected early-stage patient group of Keratoconus, IVMED-80 can occupy a fair market share with this segment of patients in the coming years based on their sanguine approach toward the development of the topical medication. However, IVMED-80, due to its unique target pool, will not be as efficient in terms of competing with procedures such as cross-linking and Keratoplasty, which are usually performed in progressive or severe Keratoconus patients.

In the future, apart from lenses, the Keratoconus market will also be dominated by cross-linking procedures as well as IVMED-80, only if approved. DelveInsight has evaluated and analyzed this market comprehensively, leading to approximately a market worth of USD 2,715 million in the year 2020, which seems to be relatively high due to the sky-high cost burden of the current procedures conducted by the physicians worldwide.