peptides and macular degeneration

Posted by 56huxley @sjs1, Mar 7 7:51pm

The Peptide (Forzinity): This new prescription medicine is available off label now for both wet and dry intermediate and GA. It's used on label for Barth's disease but I understand that this peptide supports the mitochondria so the RPE cells don't die off.
Please discuss with your retina doctor. It's very expensive but capped at 2000 part D. There are drug discounts. A MD PhD retina specialist at a major hospital would likely be the best to approach to see if the peptide would help in your case. A regular clinical retina doctor may not be as well informed. I've emailed and sent a letter off to a specialist in my area who is a MD PhD to see if I could be considered as a candidate for this prescription. Is anyone else informed on the use of this peptide? From a google search-
Key Medical Details
Mechanism of Action: It binds to cardiolipin, a key lipid in the inner mitochondrial membrane, stabilizing mitochondrial structure and improving energy (ATP) production.
Administration: Administered as a once-daily subcutaneous injection (under the skin).
Approval Status: Granted accelerated approval by the FDA in September 2025. Continued approval may depend on further clinical benefit verification.
Common Side Effects: Mostly mild-to-moderate injection site reactions, such as redness, pain, or swelling.
Developer Information
Manufacturer: Developed by Stealth BioTherapeutics.
Regulatory History: The drug, previously known as SS-31 or Bendavia, underwent a decade-long development journey and faced an initial FDA refusal in 2021 before its eventual approval.
Future Indications: It is also being studied for other conditions, including primary mitochondrial myopathy and dry age-related macular degeneration.
Patient & Caregiver Resources
Dosage: The standard recommended dose for eligible patients is 40 mg daily.
Support: Stealth BioTherapeutics has launched the Mito Assist Patient Support Program to help with access

Interested in more discussions like this? Go to the Eye Conditions Support Group.

56huxley | @sjs1 | Mar 9 10:04am

The Reclaim studies for this peptide for the intermediate dry class AMD have finished testing now but the GA phase clinical study is open. Ask about the ReNEW Phase III trial at clinicaltrials.gov (search NCT number for ReNEW/SPIAM-301) to find enrolling sites near you. A trial gives you structured access, monitoring, and your of-pocket drug costs are covered. You inject like a gPl-1. I will try to get off label use of this new SS31 peptide if I can. I cant wait until 2028 when its research trials end for the AMD trials which are going well and its on mtk for mac degen. It's FDA approved for Barths syndrome now and can be used off label. It's a game changer. Injectable peptides you inject yourself for eye degeneration not eyeball shots are a big deal. It's bigger than photobiomodulation and Valdea.