Ocugen Says Bahamas Regulator Gave Provisional Approval To OCU400 Early Access Program
Full approval and patient dosing are expected within 90 days, and Ocugen cites potential revenue of $1-2M per patient.
Ocugen said a Bahamas regulator has given provisional approval to its OCU400 gene therapy for retinitis pigmentosa under an early access program, according to an investor presentation furnished with an 8-K on Thursday. The program is open to patients worldwide at commercial pricing.
What the presentation says
The regulator, LARTA (the Bahamas' Longevity and Regenerative Therapies Board), also granted priority designation. Full approval, which the deck says is focused on logistics such as site readiness and activation and patient dosing, is expected within 90 days under a regulated early access program.
Ocugen calls it the first approval of OCU400 for a broad retinitis pigmentosa indication, covering early- to late-stage disease and pediatric to adult patients. The company says it could earn revenue from the program of potentially $1-2M per patient, citing a paper in the journal Retina on the cost-effectiveness of gene-agnostic treatment.
The 8-K itself is a Regulation FD filing: the deck is furnished, not formally "filed," and Ocugen said it would post it on its website Thursday.
What it changes
The approval gives OCU400 a route to paying patients before any major-market approval. Nothing is final yet: full LARTA approval and first dosing are still ahead.
The deck's timelines for the main program do not fully agree. The OCU400 slide shows a 140-patient Phase 3 trial with topline data in the first half of 2027 and a U.S. biologics license application target of the second quarter. The milestones slide instead lists Phase 3 topline data in the second quarter of 2027 and the application in the third quarter.
The deck projects that 71.4% (5 of 7) of treated eyes will meet the revised Phase 3 success threshold of at least a 2 lux level improvement on the LDNA scale. The trial uses a 2:1 randomization of treatment versus untreated control.
The partnership terms in the deck were reported earlier: a Kwangdong deal with potential sales milestones of up to $180M+ and 25% royalties, first shown in an August 8-K, and a Roots Pharmaceutical deal with milestones up to $255 million and 22% royalties, first shown in a July 8-K.
What to watch
The next markers are full LARTA approval and the first patient dosed, both expected within 90 days. Beyond OCU400, the deck lists three biologics license applications targeted by 2028, for retinitis pigmentosa, Stargardt disease and geographic atrophy.
Ocugen's own deck puts the OCU400 application in either the second or third quarter of 2027, depending on the slide.
Sources
- 8-K Filing — Ocugen, Inc. (OCGN) — SEC EDGAR
- Exhibit tm2627592d2_ex99-1.htm — Ocugen, Inc. 8-K exhibit — SEC EDGAR
