Ocugen reports Q2 2026 update with FDA clearance for OCU410 Phase 3 and $130M raise

Ocugen announced on August 6, 2026 that it received FDA clearance to initiate the OCU410 Phase 3 trial for geographic atrophy secondary to dry age-related macular degeneration, with the trial on track to start this quarter, and that OCU410 was granted Regenerative Medicine Advanced Therapy designation, making it eligible for priority review and accelerated approval.¹ The Phase 3 study, called ArMaDa3, is planned as a combined global trial of approximately 237 subjects powered at 95% for the primary endpoint, with BLA and MAA filings targeted for 2028.¹ The company said the trial design was supported by positive 12-month Phase 2 ArMaDa data showing a statistically significant 31% reduction in GA lesion growth versus control in patients with lesion size between 2.5 and 17.5 mm2, at p<0.05, at the dose chosen for Phase 3.¹

In the Stargardt disease program, Ocugen said it finished enrolling and dosing 63 patients in the Phase 2/3 trial known as "GARDian3," which the company described as covering all Stargardt mutation types, and that the enrollment was completed ahead of schedule, in less than nine months.¹ Topline results are anticipated in the second quarter of 2027, with a BLA submission expected to follow mid-2027.¹

For OCU400 in retinitis pigmentosa, the company completed enrollment in the "liMeliGhT" trial (N=140)¹ and said FDA feedback confirmed the path to a rolling BLA submission remains linked to topline data expected in the first quarter of 2027.¹ Separately, Ocugen signed a binding term sheet with Roots Pharmaceutical and its partner Al-Dhow International Holding to negotiate exclusive rights to OCU400 for retinitis pigmentosa across the Middle East and North Africa, with terms including up to $255 million in sales milestones and a 22% royalty on net sales, plus a modest upfront payment.¹

On financing, Ocugen closed $130.0 million in 6.75% Convertible Senior Notes due 2034, including full exercise of a $15.0 million over-allotment option, for net proceeds of about $112.5 million.¹ It said roughly $32.7 million of those proceeds was used to pay off the Avenue Capital loan in full, removing debt that carried a 12.25% interest rate.¹ Cash, cash equivalents, and restricted cash totaled $100.4 million as of June 30, 2026, compared to $32.2 million as of March 31, 2026,¹ which the company said extends its cash runway into 2028.¹