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OCGN Advances Gene Therapy OCU410 In Phase III for Geographic Atrophy
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Key Takeaways
Ocugen dosed the first patient in the pivotal phase III ArMaDa3 study for geographic atrophy.
OCU410's phase III study will enroll 237 patients and assess lesion growth and functional vision.
Ocugen expects to file a BLA for OCU410 in 2028, with Europe discussions also underway.
Ocugen (OCGN - Free Report) announced that it has dosed the first patient in the global phase III ArMaDa3 study evaluating the modifier gene therapy candidate, OCU410, for treating geographic atrophy (“GA”) secondary to dry age-related macular degeneration (dAMD).
The initiation of the phase III study follows a Type B End-of-phase II meeting with the FDA's Center for Biologics Evaluation and Research in July 2026. Per management, the meeting resulted in alignment on key phase III design elements, including the primary and secondary endpoints, dose, adaptive design and a single pivotal study pathway intended to support a biologics license application (“BLA”) for OCU410.
The randomized, phase III registrational study, which also happens to be the first pivotal gene therapy study in GA, will enroll 237 patients with GA secondary to dAMD. Patients will be randomized 2:1 to receive a single 200 µL subretinal injection of OCU410 at a dose of 5×10^10 vg/mL or remain in an untreated control arm. The primary endpoint of the study is to check the rate of change in square root-transformed GA lesion area through month 12 using fundus autofluorescence.
Secondary endpoints will evaluate functional vision, including the proportion of patients experiencing a loss of at least 15 ETDRS letters in low-luminance visual acuity, as well as the rate of change in ellipsoid zone area loss.
OCGN Price Performance
Year to date, shares of Ocugen have declined 1.5% against the industry’s 9.7% increase.
Image Source: Zacks Investment Research
OCGN’s Recent Developments With OCU410
In July 2026, the FDA granted a Regenerative Medicine Advanced Therapy (“RMAT”) designation to OCU410 for the treatment of GA secondary to dAMD.
The RMAT designation provides OCU410 with eligibility for accelerated approval and priority review, along with benefits associated with Breakthrough Therapy designation. It also enables enhanced and frequent interactions with the FDA during the development process.
Both the phase III study and the FDA’s RMAT designation are based on 12-month data from the phase II ArMaDa study, which evaluated OCU410 in patients with GA secondary to dAMD. Data from the same showed a statistically significant 31% reduction in lesion growth compared with control at the intended medium dose, along with 27% ellipsoid zone preservation versus control.
In addition, approximately 20% of patients in the medium-dose group showed no disease progression, while 75% experienced more than a 30% reduction in lesion growth at 12 months. No treatment-related adverse side effects were reported either.
Ocugen expects to file a BLA for OCU410 in 2028. The company is also in discussions with the European Medicines Agency regarding alignment that could potentially allow the single phase III study to support a marketing authorization application for OCU410 in Europe.
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View the Zacks #1 Rank List
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OCGN Advances Gene Therapy OCU410 In Phase III for Geographic Atrophy
Key Takeaways
Ocugen (OCGN - Free Report) announced that it has dosed the first patient in the global phase III ArMaDa3 study evaluating the modifier gene therapy candidate, OCU410, for treating geographic atrophy (“GA”) secondary to dry age-related macular degeneration (dAMD).
The initiation of the phase III study follows a Type B End-of-phase II meeting with the FDA's Center for Biologics Evaluation and Research in July 2026. Per management, the meeting resulted in alignment on key phase III design elements, including the primary and secondary endpoints, dose, adaptive design and a single pivotal study pathway intended to support a biologics license application (“BLA”) for OCU410.
The randomized, phase III registrational study, which also happens to be the first pivotal gene therapy study in GA, will enroll 237 patients with GA secondary to dAMD. Patients will be randomized 2:1 to receive a single 200 µL subretinal injection of OCU410 at a dose of 5×10^10 vg/mL or remain in an untreated control arm. The primary endpoint of the study is to check the rate of change in square root-transformed GA lesion area through month 12 using fundus autofluorescence.
Secondary endpoints will evaluate functional vision, including the proportion of patients experiencing a loss of at least 15 ETDRS letters in low-luminance visual acuity, as well as the rate of change in ellipsoid zone area loss.
OCGN Price Performance
Year to date, shares of Ocugen have declined 1.5% against the industry’s 9.7% increase.
Image Source: Zacks Investment Research
OCGN’s Recent Developments With OCU410
In July 2026, the FDA granted a Regenerative Medicine Advanced Therapy (“RMAT”) designation to OCU410 for the treatment of GA secondary to dAMD.
The RMAT designation provides OCU410 with eligibility for accelerated approval and priority review, along with benefits associated with Breakthrough Therapy designation. It also enables enhanced and frequent interactions with the FDA during the development process.
Both the phase III study and the FDA’s RMAT designation are based on 12-month data from the phase II ArMaDa study, which evaluated OCU410 in patients with GA secondary to dAMD. Data from the same showed a statistically significant 31% reduction in lesion growth compared with control at the intended medium dose, along with 27% ellipsoid zone preservation versus control.
In addition, approximately 20% of patients in the medium-dose group showed no disease progression, while 75% experienced more than a 30% reduction in lesion growth at 12 months. No treatment-related adverse side effects were reported either.
Ocugen expects to file a BLA for OCU410 in 2028. The company is also in discussions with the European Medicines Agency regarding alignment that could potentially allow the single phase III study to support a marketing authorization application for OCU410 in Europe.
OCGN’s Zacks Rank & Stocks to Consider
Ocugen currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the biotech sector are Repligen (RGEN - Free Report) , Anika Therapeutics (ANIK - Free Report) and Precigen (PGEN - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have gained 3.8% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for Anika Therapeutics’ 2026 earnings per share have risen from 41 cents to $1.05, while estimates for 2027 have increased from 46 cents to 95 cents during the same time. ANIK’s shares have surged 119.7% year to date.
Anika Therapeutics’ earnings beat estimates in each of the trailing three quarters, with the average surprise being 950.00%.
Over the past 60 days, Precigen’s estimates for 2026 have moved from a loss of 2 cents per share to earnings of 25 cents, while estimates for 2027 have increased from 25 cents to 86 cents during the same time. PGEN’s shares have rallied 64.2% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 108.96%.