$OCGN couldn’t imagine having to get up to 12 eye injections a year. With OCU410 being a one and done therapy it be hard to imagine anyone not switching, then add the fact it’s twice the efficacy, psh game over they’re gonna have the whole market to themselves. 🍻

$OCGN sure and given what the DMC said it makes perfect sense. OCU410ST interim is pretty simple. Baseline lesion size is the driver of Stargardt progression. Larger lesions grow 2.7x faster than smaller lesions. The interim only looked at 26 patients, and the DMC said there was a baseline lesion size imbalance between the groups. That imbalance is not present in the full study population. The data skew in the interim was due to this imbalance and why they recommended to continue instead of ending and will look at the full 8 month dataset that won’t have the imbalance. Phase 1 showed OCU410ST slowed lesion growth by 52% at 6 months and 54% at 12 months, plus a 116% relative reduction in EZ loss. So with treated patients in that first 26 having larger lesions, they were naturally expected to progress much faster. Even with the same 54% treatment effect from Phase 1: 2.7 × 0.46 = 1.24 Meaning the treated group could look about 24% worse on raw lesion growth while the drug was actually cutting progression by more than half. 8 month data will show us pure results of the drug.

$OCGN 😂🍻💸🏦

$OCGN Holy shit fam, this is insanely bullish. All these approved ga drugs needed multiple phase 3's, fda is so confident with Ocugen’s drug they only need one and they even reduced the size of it. FDA gave our trial basically the highest confidence you could ask for, a 95% power design, meaning based on our Phase 2 results they see this Phase 3 as having only about a 1 in 20 chance of missing because of some unlucky anomaly. Basically, OCU410’s effects should show up in this trial with very little statistical noise or other X factors fucking with the outcome. The best part of it all is that Ocugen does not need to show anywhere near the same results we saw in Phase 2. OCU410 showed a 31% reduction in lesion growth rate in Phase 2, and honestly I could even argue the small sample size skewed that number lower than what a larger trial would have shown. Even if our Phase 3 only showed around a 18%+ reduction, it would still likely be enough for approval. It really isn’t until you get down around 17% or lower where you start risking the endpoint. Clearly Ocugen has uncovered something incredible here. The biological insight is showing up across 3 separate blinding diseases, with evidence that these therapies can stop disease progression and restore function. Data this strong does not always get reflected in the regulatory pathway, so it’s nice as hell to see the FDA continuing to recognize the significance of all 3 of Ocugen’s drugs. They’ve shaped 2 Phase 3 trials and a pivotal Phase 2/3 into one of the fastest and easiest paths to market you’ll ever see in this industry. Thankfully, because people are desperate for a one and done therapy, let alone one showing far better results. Now they may be looking at one coming remarkably soon. 🍻 ir.ocugen.com/news-releases/…