BEDFORD, Mass. - Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company, announced positive topline results from its Phase 1 HELIOS study of AXPAXLI in treating non-proliferative diabetic retinopathy (NPDR).
The study found that 46.2% of patients in the AXPAXLI arm showed improvement in the Diabetic Retinopathy Severity Scale (DRSS) at 40 weeks, with no cases of worsening, in contrast to a 12.5% worsening in the control group.
The HELIOS study, a randomized clinical trial conducted across 10 U.S. centers, focused on the safety and efficacy of AXPAXLI compared to a sham control. The primary endpoint was the frequency of treatment-emergent adverse events, with secondary endpoints including changes in DRSS and best corrected visual acuity, among others.
AXPAXLI, a bioresorbable hydrogel implant with axitinib, has shown a durable effect up to 40 weeks without the need for rescue medication. These findings have prompted Ocular to plan a Phase 3 study for AXPAXLI, pending discussions with the FDA.
Dr. Jeffrey S. Heier, CSO of Ocular Therapeutix, highlighted the decision to accelerate the diabetic retinopathy program to Phase 3 based on the observed safety and efficacy. Dr. Dilsher Dhoot, a principal investigator in the study, noted the consistent efficacy signals favoring AXPAXLI.
Ocular Therapeutix specializes in therapies for wet AMD (NASDAQ:AMD), diabetic retinopathy, and other eye conditions. Their portfolio includes the FDA-approved corticosteroid DEXTENZA and several other clinical and preclinical programs.
The company plans to present the full results from the HELIOS study at an upcoming meeting. This article is based on a press release statement from Ocular Therapeutix, Inc.
InvestingPro Insights
Ocular Therapeutix, Inc. (NASDAQ:OCUL) has shared promising results from its HELIOS study, potentially positioning the company for a Phase 3 trial and further growth. In light of these developments, a review of the company's financial health and stock performance provides additional context for investors considering the stock's future prospects.
According to InvestingPro data, Ocular Therapeutix currently holds a market capitalization of $1.13 billion. Despite the positive study outcomes, the company's financials reflect some challenges, with a negative gross profit margin of -13.51% over the last twelve months as of Q4 2023, indicating that the cost of goods sold exceeds the revenue generated from those goods.
Furthermore, the company's operating income margin stands at -140.96%, suggesting substantial operating costs relative to its revenue.
InvestingPro Tips reveal that analysts have revised their earnings upwards for the upcoming period, which could signal confidence in Ocular's future performance. Additionally, the stock's Relative Strength Index (RSI) suggests it is in oversold territory, which might attract investors looking for potential rebounds.
Despite the lack of profitability over the past year and weak gross profit margins, Ocular's stock has experienced a significant price uptick over the last six months, with a 219.16% total return. This could reflect investor optimism about the company's long-term growth potential, especially in light of the recent study results.
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