Cloudbreak clears up truth of pterygium symptoms, treatment in survey of eye disease med trial volunteers

Cloudbreak Pharma is riding the wave of new survey results highlighting patients’ desire for a new treatment option for the ocular disease pterygium—say, like the drug that Cloudbreak, coincidentally, is currently developing.

The Southern California biotech shared the survey’s findings during the American Society of Cataract and Refractive Surgery’s annual meeting in Boston this month. The 60 respondents came from the pool of volunteers for Cloudbreak’s ongoing phase 3 trial of its lead candidate, CBT-001, a multikinase inhibitor aimed at slowing or stopping the progression of pterygium and either postponing or completely eliminating the need for eye surgery to treat the condition.

Pterygium, also known as “surfer’s eye,” is most commonly caused by long-term exposure to the sun’s UV rays and results in an overgrowth of the conjunctiva tissue, which can spread from the inner corner of the eye to the cornea, potentially affecting vision and causing irritation. Data cited by Cloudbreak in Friday’s announcement suggest that around 15 million people in the U.S. alone have pterygium, and only about one in every six of those people have actually received a formal diagnosis.

Currently, according to the company, there are no approved pharmacological treatments specifically for pterygium; patients may seek symptom relief via eye drops or undergo surgery to remove the growth, which may not be a permanent solution.

According to the survey results (PDF), more than three-quarters of respondents said they were “extremely interested” in a new eye-drop-based treatment that would both address their symptoms and delay the need for surgery. More than 60% of those surveyed had already tried at least one type of prescription or over-the-counter eye drops, and 13% had undergone surgery for the condition—though all saw their pterygium recur after the procedure.

While 22% of patients said they hadn’t yet faced any challenges while being treated for pterygium, about half felt differently, citing as their biggest challenges the limited and ineffective treatment options and the impact of symptoms on their mental health and daily lives.

The survey also uncovered a slow road to pterygium diagnosis: About half of respondents said they didn’t consult a healthcare provider until at least two years after they first began experiencing symptoms, and fewer than 60% received their diagnosis within a month of reporting their symptoms to a doctor. In total, nearly 90% of patients were already symptomatic by the time they received a diagnosis, with irritation, discomfort and the sensation of a foreign body in their eye the most common pre-diagnosis symptoms.

And those symptoms continue long after the issue has been identified. More than 50% of respondents said they still experience redness, irritation, foreign body sensation, sensitivity to light or itchiness, and, when they were asked to rate the level of burden of 12 symptoms, all received an average rating of at least “mild bother,” with light sensitivity crossing into “moderate bother” territory and a handful of others—including foreign body sensation, blurred vision and dryness—not far behind.

Altogether, half of those surveyed said pterygium has a “considerable” impact on their lives and can affect their daily activities, per Cloudbreak.

“Pterygium is far more common and has far more impact on patients—than implied by the casual name, ‘surfer’s eye.’ Chronic symptoms can impose a daily burden on people grappling with the disease, and unfortunately many people who experience symptoms face challenges receiving a formal diagnosis,” Abu Abraham, M.D., Cloudbreak’s chief medical officer, said in the company release. “Cloudbreak Pharma recognizes the urgent and growing need for new non-surgical treatment options to address the debilitating symptoms associated with pterygium and help delay or avoid the need for surgery for these patients for whom there have been so few options.”

According to the biotech, the CBT-001 asset showed “positive results” in its phase 2 trial, which assessed the med’s ability to reduce pterygium vascularity and inhibit lesion growth when administered three times a day for four weeks. The phase 3 trial, meanwhile, will study twice-daily doses for 24 months, with primary endpoints of reducing conjunctival hyperemia caused by pterygium and inhibiting lesion length progression.