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Ocugen Advances Blindness Therapies for 2025-2028

Summary

  • Ocugen plans BLA filings for retinitis pigmentosa and Stargardt disease next year.
  • A geographic atrophy BLA is targeted for submission in 2028.
  • Phase 3 trials for geographic atrophy will begin in Q3 with regulatory alignment.
Ocugen Advances Blindness Therapies for 2025-2028

Ocugen is advancing its pipeline of late-stage retinal disease treatments, with plans for biologics license applications (BLA) targeting retinitis pigmentosa and Stargardt disease in 2027. Furthermore, the company expects to file a BLA for geographic atrophy in 2028. These programs address critical unmet needs in inherited retinal diseases and dry age-related macular degeneration.

The company is currently conducting Phase 3 trials for its retinitis pigmentosa and Stargardt disease candidates. A global Phase 3 program for geographic atrophy, utilizing the OCU410 gene therapy, is slated to commence in the third quarter of 2026. Ocugen has secured alignment with regulators in both the U.S. and Europe for this trial. OCU410 employs a modified RORA gene, which is also leveraged in the Stargardt program, aiming to regulate key disease progression pathways.

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